AltPep Study Published in Nature Journal, Scientific Reports, Further Affirms Potential of Blood Test to Detect Alzheimer's Disease

April 05, 2024 - AltPep Corporation , a privately held biotechnology company dedicated to early disease-modifying treatments and detection tools for amyloid diseases, announced that the peer-reviewed Nature journal Scientific Reports has published new results from the Company’s evaluation of its novel SOBA-AD blood test, aimed at detecting Alzheimer’s disease (AD).

The data, consistent with an earlier study, further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD. The SOBA-AD blood test targets toxic soluble oligomers, an early molecular trigger of amyloid diseases, with the ultimate goal of identifying patients with the disease years before symptoms manifest.

In the report titled “Performance of SOBA-AD blood test in discriminating Alzheimer’s disease patients from cognitively unimpaired controls in two independent cohorts”, 265 blinded plasma samples from two independent cohorts were tested at two different sites. The SOBA-AD blood test identified AD patients from cognitively unimpaired (CU) subjects with 100% sensitivity, >95% specificity, and >98% area under the curve (95% CI 0.95-1.00)... AltPep's Press Release -

AlzeCure gets Late Breaking abstract of new preclinical data with ACD856 accepted at AD/PD 2024 conference

February 6, 2024 - AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops candidate drugs for CNS diseases, focusing on Alzheimer's disease and pain, announced that an abstract on preclinical data with its lead drug candidate NeuroRestore ACD856 has been accepted for a poster presentation at AD/PD 2024, which will be held in Lisbon on March 5-9.

The abstract, titled ACD856 is a biased positive allosteric modulator of Trk-receptors – Enhances neurite outgrowth but do not affect pain signaling, will be presented at the international conference AD/PD 2024 on Alzheimer's, Parkinson's and Related Neurological Disorders by Pontus Forsell, Head of Discovery and Research at AlzeCure. Co-authors are Veronica Lidell, Azita Rasti, Gunnar Nordvall and Johan Sandin.

The presentation includes study results showing that ACD856, the lead drug candidate in the NeuroRestore platform being developed with a focus on Alzheimer's disease, selectively appears to potentiate some signaling pathways, but not others. New preclinical data show that the substance stimulates the growth of nerve cell projections, which can promote nerve cell communication, but does not affect other functions, such as pain signaling. Previous studies have also been able to show that ACD856 improves memory, synaptic plasticity and has neuroprotective properties... AlzeCure Pharma's Press Release -

INmune Bio Announces FDA Removal of Clinical Hold for Alzheimer’s Disease Program

The Phase II clinical trial in patients with Alzheimer’s disease with neuroinflammation is on track to complete enrollment mid-2024 with top line data expected approximately six months after the final patient is enrolled.  

BOCA RATON, Florida, Jan. 30, 2024 -- INmune Bio Inc. (NASDAQ: INMB)  (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted. The Phase II trial is on track to enroll the last patient mid-2024. Top line data is expected approximately six months after the last patient is enrolled.

“We are pleased with the FDA’s response and will continue to work closely with the agency in anticipation of our Phase III AD program,” said RJ Tesi, CEO of INmune Bio. “Our primary goal is to complete the Phase II program in 2024 followed by an end-of-Phase II meeting with the FDA in early 2025 to confirm our planned global Phase III trial that will include sites in the U.S., Canada, U.K., E.U. and Pacific Rim.”... INmune Bio's Press Release -

IGC Pharma Activates ClinCloud, One Of 12 Sites In Ongoing Phase 2b Alzheimer’s Trial

 POTOMAC, Md., January 17, 2024 – IGC Pharma, Inc (NYSE American: IGC) (“IGC” or the “Company”), announced that ClinCloud, a clinical research facility in Florida, has dosed its first patient as part of the Company’s ongoing Phase 2b trial.

IGC Pharma is currently conducting a Phase 2b trial at twelve sites in the US and Canada with IGC-AD1, a combination medicine with a CB1 receptor partial agonist with anti-neuroinflammatory properties, and an inflammasome inhibitor to treat agitation in dementia from Alzheimer’s. Neuroinflammation, neurotransmitter imbalance, loss of CB1 receptors, and inflammasome-3 have been implicated in agitation/aggression.

ClinCloud has two sites in Florida, one in Maitland and the other in Viera-Melbourne. Individuals diagnosed with Alzheimer’s disease and/or their caregivers who live near the sites are encouraged to contact ClinCloud for information regarding enrolling in the trial. Contact information is available at clincloudresearch.com.

Jessica Branning, founder of ClinCloud, commented, “Treatment options targeting agitation in Alzheimer’s disease are currently limited. This symptom is present in over 50-80% of Alzheimer’s patients and is a source of significant distress for both patients and their caregivers. We’re glad to support this Phase 2b clinical trial as it aligns with ClinCloud’s goal of transforming healthcare with continuous improvements and revolutionary breakthroughs. As the global population ages, it is more important than ever to identify treatments for neuropsychiatric conditions. An oral solution with the ability to reduce agitation in Alzheimer’s would have a significant impact on patients’ quality of life.”

Ram Mukunda, CEO of IGC Pharma stated, “We are excited to announce this important addition to our Phase 2b trial of IGC-AD1. This strategic expansion amplifies our reach and strengthens the depth of our data collection, marking a critical phase in our pursuit of an innovative therapy for agitation in Alzheimer’s disease. The expansion of our trial network underscores our commitment to a robust, scientifically driven approach, advancing our confidence in the potential of IGC-AD1. We continue to see progress in patient and trial site recruitment. I am optimistic that our partnership with ClinCloud will bring us closer to developing an effective and safe therapy to address the global challenge of Alzheimer’s disease.”

IGC Pharma has 12 sites and is on target to roll out additional sites in the U.S. and in Canada to increase population diversity and promote the inclusion of underrepresented populations. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo... IGC Pharma's Press Release - 

Athira Pharma Completes Enrollment of Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Topline data from LIFT-AD on track for second half of 2024

Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton

Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases

BOTHELL, Wash., Jan. 03, 2024 --  Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced completion of enrollment in the Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease.  

Fosgonimeton is a potentially first-in-class, investigational, small molecule designed to positively modulate the hepatocyte growth factor (HGF) system, which can activate neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system.

“The successful completion of enrollment in LIFT-AD marks an important milestone for Athira and enables the topline data readout in the second half of 2024,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We believe LIFT-AD has the potential to meet the study’s primary endpoint based on the unblinded interim efficacy and futility analysis performed by an independent committee on the first 100 patients who completed the trial. This interim analysis gives us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes.”

“We are also encouraged that more than 85% of participants who completed the LIFT-AD and ACT-AD clinical trials elected to participate in the open label extension trial (OLEX). Notably, there are currently more than 60 patients in this open label trial who are continuing fosgonimeton treatment beyond 18 months, which is unexpected in a progressive mild-to-moderate Alzheimer’s disease population. We also recently reported findings from the exploratory SHAPE Phase 2 clinical trial, which investigated the use of fosgonimeton in patients with Parkinson’s disease dementia and dementia with Lewy Bodies. The results showed positive effects on several cognitive measures in the fosgonimeton 40 mg dose group, which is the same dose being investigated in the LIFT-AD trial. Collectively, the extended duration of OLEX participation and the SHAPE findings add to our confidence for a positive LIFT-AD outcome and support the potential of our HGF modulation franchise in neurodegeneration,” added Dr. Litton.

The Phase 2/3 LIFT-AD clinical trial, which targeted an enrollment of 298 patients in the primary analysis population, ultimately enrolled approximately 315 patients with mild-to-moderate Alzheimer’s disease in a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo. The primary endpoint is the Global Statistical Test (GST), a composite of the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23. Key secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation. Additional information about the LIFT-AD study can be found at: NCT04488419... Athira Pharma's Press Release -

Fujirebio expands its Alzheimer’s disease test menu with the much awaited and fully automated Lumipulse® G pTau 217 Plasma assay for Research Use Only (RUO)

Gent, Belgium, Malvern PA, United States, and Tokyo, Japan, December 22nd, 2023 – H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

“The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”

About pTau 217

Current research indicates that plasma pTau, including pTau 217, is a predictor of amyloid status determined either by CSF1 or PET2, and therefore able to differentiate between Alzheimer’s disease (AD) and non-AD neurodegenerative diseases3,4 and to predict progression to AD.5,6 Blood-based biomarkers, such as plasma pTau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy in clinical trials, and could further advance the development and implementation of disease-modifying treatments in the field of AD and related disorders.7 This assay is designed to measure specifically the phosphorylation on position threonine 217 in human plasma.

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information at Fujirebio Alzheimer. - Fujirebio's Press Release  – H.U. Group's press Release [PDF] -

LEQEMBI® to be launched in Japan for Alzheimer’s disease on December 20

Stockholm, Sweden, December 13, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced that LEQEMBI (lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) drug price list.

LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan’s NHI drug price list, the products Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Heath, Labour and Welfare, held today. The launch, planned for December 20, will make Japan the second country to have the product on the market, following the U.S.

"This is a great Christmas present! Alzheimer's disease patients in Japan will now have access to the first disease modifying treatment. This gives hope for the large aging population in Japan with a great need for new treatment options," says Gunilla Osswald, CEO of BioArctic.

LEQEMBI selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[1]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Eisai will conduct a post-marketing special use results survey in all patients who are administered LEQEMBI (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and the Optimal Clinical Use Guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (ARIA).

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region... BioArctic's Press Release - Eisai's Press Release- Biogen's Press Release -

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.

Agitation symptoms negatively impact functioning, disease progression, quality of life and care for about half of Alzheimer’s dementia patients – and are a consistent predictor of nursing home admission.

REXULTI® is the first drug approved by the FDA for agitation associated with dementia due to Alzheimer’s disease.

November 06, 2023 - PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce that treatment with REXULTI® (brexpiprazole) resulted in statistically significant and clinically meaningful improvements in adult patients with agitation associated with dementia due to Alzheimer’s disease, according to the complete results of the placebo-controlled pivotal phase 3 Study 213 (NCT03548584), published today in JAMA Neurology.1 In May 2023, brexpiprazole became the first and only drug to receive approval from the Food and Drug Administration for this indication. REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Study 213 is the second pivotal phase 3 study, in addition to Study 283 (NCT01862640), to report positive efficacy and good tolerability for brexpiprazole, compared to a placebo, when used to treat patients with agitation associated with dementia due to Alzheimer’s disease.2 The JAMA Neurology publication is the first to report the efficacy of brexpiprazole to significantly improve each of three classifications of agitation symptoms: aggressive behaviors, physically nonaggressive behavior and verbally agitated behavior... Otsuka and Lundbeck's Press Release -  TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03548584

 

Alzheon Announces Phase 1 Results of ALZ-801, a First-in-Class Inhibitor of Amyloid Formation and Neurotoxicity for Alzheimer’s Disease

March 20, 2015 - LEXINGTON, Mass.- Alzheon, Inc., a clinical-stage biopharmaceutical company focused on brain health, memory and aging, today announced that the company presented Phase 1 clinical data for ALZ-801, a first-in-class small molecule inhibitor of amyloid formation and neurotoxicity for the treatment of Alzheimer’s disease. As additional support to the clinical program for ALZ-801, Alzheon presented expanded post-hoc analyses of Phase 3 data with tramiprosate, the parent molecule of the optimized prodrug ALZ-801, which demonstrated sustained efficacy on cognition and function in a population of patients with Alzheimer’s disease that are positive for the ε4 gene variant of apolipoprotein E (ApoE4), associated with increased risk of Alzheimer’s disease. The Phase 1 results and Phase 3 post-hoc clinical analyses were presented at a poster session today at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases in Nice, France... [PDF] Alzheon's Press Release -

Higher dose of Novartis drug Exelon® Patch approved by FDA for patients with mild to moderate Alzheimer's disease

Sept. 4, 2012 - The US Food and Drug Administration has approved a higher dose of Exelon® Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease. The new 13.3 mg/24 h dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. 

"Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver," said Jeffrey Cummings, MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."... Novartis' Press Release -

ReproCELL launches Alzheimer’s disease model based on iPS-derived human neuronal cells

7th June 2012 - ReproCELL, Inc. (CEO: Chikafumi Yokoyama PhD) announces that the company will start commercializing human iPS-derived neurons in which an Alzheimer’s disease related gene has been incorporated.

ReproCELL’s scientists have successfully incorporated a gene related to Alzheimer’s disease using homologous recombinant genetic engineering technology into undifferentiated human iPS cells and then differentiated them into neurons. In these cells, it has been confirmed that amyloid beta 42 is accumulated at higher levels compared to normal neurons. This phenomena is similar to what is observed in neurons of Alzheimer’s patients. Accordingly, ReproCELL’s scientists believe the newly developed iPS cells can be useful for drug screening to identify new therapeutic molecules to treat Alzheimer’s disease patients.... ReproCELL's Press Release -

Axerion Therapeutics and AstraZeneca to Develop and Commercialize a Biologic Approach for the Treatment of Alzheimer’s Disease

May 1, 2012 - Axerion Therapeutics, Inc., a private Connecticut-based biotechnology company, and MedImmune the global biologics arm of AstraZeneca, announced that they have entered into a research collaboration and sublicense arrangement to develop and commercialize a biologic approach for the treatment of Alzheimer's disease.

The agreement with Axerion is the first collaboration signed within the new Neuroscience Innovative Medicines Unit that AstraZeneca announced in February 2012. Under this model, AstraZeneca and MedImmune will conduct neuroscience discovery research and early development for small and large molecules by tapping into the best available external science and sharing cost, risk and reward with other research partners active in psychiatry, neurology and pain research.

Under the terms of the agreement, Axerion has granted the AstraZeneca Neuroscience Innovative Medicines Unit an exclusive sublicense* to research, develop and commercialize a pre-clinical biologic that targets the binding of A-beta oligimers to prion proteins.

In exchange, the AstraZeneca Neuroscience Innovative Medicines Unit will provide Axerion with certain upfront and milestone payments plus research and development (R&D) funding during the time both companies are working together on the program. Additionally, Axerion will earn royalties on product sales. The financial terms of the deal have not been disclosed... Axerion Therapeutics' Press Release -

Piramal Healthcare : Encouraging Phase III Study Results Show PET Imaging with Florbetaben Reliably Detects Beta-Amyloid in the Brain

April 16, 2012 - Lead Compound in newly created subsidiary Piramal Imaging SA - Piramal Imaging SA (“Piramal”), a newly formed subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], announced positive results from a Phase III study that showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease. The study results will be featured as part of the Emerging Science Program on April 25th at the American Academy of Neurology’s 64th Annual Meeting in New Orleans.

Historically, the only way to definitively diagnose Alzheimer’s disease has been after death – at autopsy – through analysis and identification of beta-amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).

Piramal has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG through its newly created subsidiary – Piramal Imaging SA. Florbetaben is the lead compound in the portfolio... Piramal Healthcare's Press Release -

Bristol-Myers Squibb and MESO SCALE DISCOVERY : Agreement to Develop Diagnostic Assays for Alzheimer's Disease

March 28, 2012  – Bristol-Myers Squibb Company (NYSE:BMY) and Meso Scale Discovery announced they have entered an agreement to develop diagnostic assays that will measure cerebrospinal fluid biomarkers for use in Alzheimer's disease research.

Under the terms of the agreement, the companies will develop these assays based on the Meso Scale Discovery® MULTI-ARRAY technology platform. Meso Scale Discovery will commercialize the assays for Alzheimer's disease research and drug development, and plans to release the assays in the second quarter of 2012. Terms of the agreement were not disclosed.

"The collaboration with Meso Scale Discovery demonstrates Bristol-Myers Squibb's commitment to advancing the science of Alzheimer's disease research," said Jane Tiller, vice president, Global Clinical Research, Bristol-Myers Squibb. "These assays could provide the Alzheimer's disease research community with an important tool to help advance understanding of this complex and devastating disease and may lead to advances in the diagnosis and treatment of Alzheimer's disease."... Meso Scale Discovery's Press Release - Bristol-Myers Squibb's Press Releases -

PhRMA : Collaborations Between Public and Private Sector Are Critical to Advance Alzheimer’s Research

February 7, 2012 — The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani responded to new efforts unveiled by the Administration to combat Alzheimer’s Disease:

“Alzheimer’s disease is one of America’s top health challenges. It ravages the minds of patients, seriously impacts entire families and currently costs the U.S. health care system $172 billion a year. According to the Alzheimer’s Association, an American will develop the disease every 33 seconds in 2050, costing the U.S. health care system $1.1 trillion. These costs are simply unsustainable.

“The outlook could change course, however, if a treatment were discovered that helps delay the onset of Alzheimer’s. Biopharmaceutical research companies, recognizing the great health and economic need to help delay or prevent the onset of Alzheimer’s, have invested heavily in this area and are currently researching and developing nearly 100 medicines to help address this public health priority.

“Discovering an Alzheimer’s treatment is by no means an easy task; and it can certainly benefit from collaborations between industry, academia and federal research institutions. In addition to their individual efforts to discover and develop novel treatments for Alzheimer’s, biopharmaceutical companies have partnered with each other and with academic and federal research institutions to help move forward the scientific understanding of this complex disease... PhRMA's Press Release -

Pfizer : Diagnosis of Alzheimer's and What You Need to Know as a Caregiver

One in eight people over 65 have Alzheimer's disease, and many more have personal experience as a family member or caregiver to someone with the disease. On The Doctors, Dr. Freda Lewis-Hall and Dr. Travis Stork discuss signs of dementia and key steps to take if you suspect someone in your life may have Alzheimer's disease. [PfizerNews on YouTube]

Medivation and Pfizer : Results from Phase 3 Concert Trial of Dimebon in Alzheimer's Disease

January 17, 2012 - Dimebon Did Not Meet Primary Efficacy Endpoints - Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer's disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale — cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer's Disease Cooperative Study — Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

"We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers," said David Hung, M.D., president and CEO of Medivation. "I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial."

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement... Medivation's Press Release - Pfizer's Press Release -

Aphios® Awarded Phase II SBIR Grant From National Institute On Aging For Alzheimer's Disease Research

January 24, 2012— Aphios® Corporation has received a Phase II SBIR grant from the National Institutes of Health (NIH) amounting to $2.4 million over two years. The National Institute on Aging (NIA), part of the NIH, awarded the grant to the Aphios Corporation to develop an “Alzheimer’s Disease Therapeutic.”

Alzheimer’s Disease (AD) is the third leading cause of death in America and among the highest in the industrial world. AD is a devastating age-related neurological disorder that affects more than 4.5 million Americans and more than 10 million people worldwide. Experts estimate that 22 million people around the world and more than 8 million Americans will be afflicted with this disease by 2025.

“Aphios is developing APH-0703, a potent protein kinase C (PKC) modulator that activates the alpha-secretase pathway which can dramatically enhance the generation of soluble amyloid precursor protein (sAPP), diminishing plaques and cognitive deficits associated with Alzheimer’s Disease,” explains Dr. Trevor P. Castor, President and CEO, Aphios Corporation. “We are developing novel formulations of APH-0703 based on Aphios’ proprietary hydrophobic-based formulation and patented SFS-PNS polymer nanospheres technologies. After formulation selection, Aphios will manufacture and characterize the API and final drug product following cGMP guidelines, and conduct preclinical studies in preparation of filing an IND with the FDA to conduct human clinical trials.”... Aphios' Press Release -

Targacept : Decision by AstraZeneca to Advance AZD1446 in Alzheimer’s Disease

January 05, 2012 - Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced that AstraZeneca has informed the company that it plans to progress the development of Targacept’s product candidate AZD1446 as a treatment for Alzheimer’s disease.

AZD1446 is a selective modulator of the alpha4beta2 neuronal nicotinic receptor that arose out of a research collaboration conducted by Targacept and AstraZeneca. Under the terms of a 2005 collaborative research and license agreement, AstraZeneca is responsible for conducting and funding the development and potential commercialization of AZD1446. The next clinical trial of AZD1446 is expected to be a Phase 2 study as an adjunct treatment to donepezil in patients with mild to moderate Alzheimer’s disease... Targacept's Press Release -

Abbott Biotech Ventures Invests in NeuroGenetic Pharmaceuticals

January 4, 2012 - Advancing Research on Therapy for Alzheimer’s Disease -

NeuroGenetic Pharmaceuticals, Inc. (NGP), a privately held biopharmaceutical company focused on Alzheimer’s disease (AD) therapeutics, has received an investment from Abbott Biotech Ventures. The amount of the investment was not disclosed. Dr. William T. Comer, president and CEO of NGP said, “The funding will expedite the development of our lead candidate, NGP 555, for the prevention of AD, including achieving our immediate goal of initiating clinical trials.”

Earlier, NGP announced that it has been awarded a Small Business Innovation Research (SBIR) fast-track grant from the National Institutes of Health (NIH) for preclinical work on NGP 555. The first phase award is in the amount of $288,000 with future awards to approach $1 million for each subsequent phase, which can be up to three rounds of additional funding for milestone-based achievements.

About NeuroGenetic Pharmaceuticals, Inc. 

NeuroGenetic Pharmaceuticals, Inc. (NGP), a biopharmaceutical discovery and development company founded in 2009, is developing innovative drug therapies for Alzheimer’s disease. Based in San Diego, Calif., the company’s next objective is to obtain an Investigational New Drug approval for its clinical candidate, NGP 555. Future clinical trials will utilize specific amyloid biomarkers and/or brain scanning as an early diagnostic and to monitor drug efficacy in clinical trials. Combining early disease identification with a treatment capable of preventing AD-related pathology, such as NGP 555, would represent an important advance in our ability to prevent AD or hinder its progression to dementia. Clearly, the earlier AD is detected and treated, the better the likelihood of a good outcome.

NGP 555, a proprietary “first in class” molecule for the treatment/prevention of Alzheimer’s disease, is a gamma-secretase modulator targeting the γ-secretase complex, a key enzyme in the amyloid pathway. The compound has excellent brain penetration and is devoid of side-effects seen with other potential amyloid therapies such as gamma-secretase inhibitors and monoclonal antibodies. Based on the pre-clinical studies in rodents, this compound is expected to prevent the formation of Aβ42 and the deposition of amyloid plaques in the human brain, thereby precluding neuronal cell death and the dementia associated with AD... NeuroGenetic Pharmaceuticals' Press Release -