Anavex Life Sciences

Anavex Completes Enrollment in Phase 2 Trial of ANAVEX®3-71 for Schizophrenia Treatment

20 days ago

• Anavex Life Sciences has successfully completed enrollment of 71 participants in its Phase 2 clinical study of ANAVEX®3-71 for schizophrenia treatment, with top-line data expected in the second half of 2025. • ANAVEX®3-71, a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, offers a novel mechanism that could potentially address all symptom domains of schizophrenia without the side effects of standard antipsychotics. • The trial addresses a significant unmet need in schizophrenia treatment, where approximately 34% of patients don't respond to current therapies and 50-60% experience only partial improvement or unacceptable side effects.

Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression

4 months ago

• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. • Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. • Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. • Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.

Anavex's Blarcamesine Shows Promise in Long-Term Alzheimer's Treatment, EMA Filing Accepted

4 months ago

• Anavex Life Sciences' blarcamesine demonstrates sustained cognitive and functional benefits in early Alzheimer's patients over three years of continuous oral treatment. • The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for blarcamesine, a potential novel oral treatment for Alzheimer's disease. • Blarcamesine targets upstream Alzheimer's pathology through autophagy enhancement and has shown a favorable safety profile in clinical trials. • Anavex is also evaluating blarcamesine for other CNS indications, including Parkinson’s disease and Rett syndrome.

FDA Approves Monthly IV Maintenance Dosing for Leqembi, Eases Treatment Burden for Alzheimer's Patients

4 months ago

• The FDA has approved a monthly intravenous (IV) maintenance dose for Leqembi, offering a more convenient treatment schedule for early Alzheimer's disease. • Patients completing the initial 18-month biweekly IV treatment can transition to monthly dosing, potentially improving long-term adherence and quality of life. • Approval is based on data modeling showing sustained clinical and biomarker benefits with monthly dosing, addressing the continuous neurotoxic processes of Alzheimer's. • Leqembi, developed by Eisai and Biogen, is now approved in multiple countries, offering a significant advancement in managing early Alzheimer's disease.

Blarcamesine Shows Sustained Cognitive Benefits in Early Alzheimer's Patients

4 months ago

• Anavex Life Sciences' blarcamesine demonstrates significant reduction in clinical decline over three years for early Alzheimer's patients. • Delayed-start analysis reveals early treatment with blarcamesine leads to greater cognitive stability, highlighting the importance of early intervention. • The ATTENTION-AD trial confirms blarcamesine's favorable safety profile, with mostly mild to moderate adverse events and no treatment-related deaths. • Peer-reviewed data from a Phase IIb/III study published in JPAD supports blarcamesine's potential as a novel oral treatment for early Alzheimer's.

Anavex Life Sciences Reports Financial Results and Clinical Advancements in Neurodegenerative Disease Research

5 months ago

• Anavex Life Sciences Corp. reported a reduced net loss of $43.0 million for fiscal year 2024, driven by decreased operating expenses and increased other income. • The company's lead drug candidate, ANAVEX®2-73, showed significant improvements in cognitive and functional endpoints in a Phase 2b/3 trial for early Alzheimer's disease. • Clinical trials for ANAVEX®2-73 in Rett syndrome demonstrated significant improvements in behavioral symptoms and safety in both adult and pediatric populations. • Anavex is advancing ANAVEX®3-71 into clinical trials for schizophrenia, frontotemporal dementia, and Alzheimer's disease after successful Phase 1 safety trials.

Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development

5 months ago

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

Anavex's Blarcamesine MAA Accepted by EMA for Alzheimer's Treatment

7 months ago

• Anavex Life Sciences' blarcamesine MAA has been accepted by the EMA for review as a potential Alzheimer's treatment, marking a regulatory milestone. • Clinical data from Phase IIb/III trials showed blarcamesine significantly improved cognition and slowed neurodegeneration in early Alzheimer's patients. • Blarcamesine offers a convenient once-daily oral administration and a favorable safety profile without requiring routine MRI monitoring. • If approved, blarcamesine could provide a novel treatment option for the 7 million Europeans affected by Alzheimer's disease.