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 -