Anavex submits blarcamesine MAA for Alzheimer's treatment to EMA
- Anavex Life Sciences has submitted a Marketing Authorization Application (MAA) for blarcamesine to the European Medicines Agency (EMA) for Alzheimer's treatment.
- Blarcamesine, an oral small molecule, showed significant improvement in ADAS-Cog13 scores over 48 weeks, indicating potential efficacy in early Alzheimer's patients.
- The drug's safety profile suggests it does not require routine MRI monitoring, offering a convenient administration route.
- This submission marks a step towards providing a novel oral treatment for Alzheimer's, potentially complementing existing therapies.
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CervoMed receives orphan drug designation for neflamapimod in frontotemporal dementia
- Neflamapimod granted Orphan Drug Designation by the FDA for frontotemporal dementia (FTD).
- Orphan Drug status offers benefits like tax credits and seven years of marketing exclusivity.
- FTD affects 50,000-60,000 people in the U.S., with no approved treatments available.
- CervoMed plans to advance neflamapimod into a Phase 3 trial for dementia with Lewy bodies in mid-2025.
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Axsome Therapeutics announces AXS-12 achieves primary endpoint in ENCORE long-term phase 3 trial in narcolepsy
- AXS-12 significantly reduced cataplexy attacks compared to placebo in the ENCORE Phase 3 trial.
- The trial included a 6-month open-label period followed by a 3-week double-blind withdrawal period.
- Patients on AXS-12 showed improvements in cognition and overall narcolepsy symptoms.
- AXS-12 was well-tolerated with a safety profile consistent with previous trials.
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Acadia Pharmaceuticals announces exclusive license agreement with Saniona for SAN711
- Acadia Pharmaceuticals has secured an exclusive worldwide license from Saniona for SAN711, a GABAA-α3 positive allosteric modulator.
- The initial focus will be on developing SAN711 for essential tremor, with a Phase 2 study planned for 2026.
- Saniona will receive $28 million upfront, with potential milestone payments up to $582 million and royalties on net sales.
- Acadia will lead clinical development, regulatory submissions, and global commercialization efforts for SAN711.
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S.BIOMEDICS investigational cell therapy for Parkinson’s disease shows positive data at 12-months in phase 1/2a clinical trial
- S.BIOMEDICS reported promising one-year data from their Phase 1/2a trial of TED-A9 for Parkinson's disease.
- The trial involved 12 participants, with 6 in low-dose and 6 in high-dose groups, showing significant improvements in motor symptoms.
- High-dose patients showed a 44.4% improvement on the Hoehn and Yahr scale, while low-dose patients improved by 19.4%.
- No safety issues related to the transplanted cells were observed, and the trial will continue to monitor safety and efficacy for 5 years.
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MaaT Pharma announces positive phase 1b results for MaaT033 in ALS
- MaaT Pharma's Phase 1b trial of MaaT033 in ALS met its primary endpoint, demonstrating safety and tolerability.
- The trial involved 15 participants across two centers in France, with support from the DSMB to proceed to Phase 2.
- Preliminary microbiome analysis confirmed successful engraftment of MaaT033, supporting its safety profile.
- Next steps include a comprehensive data analysis in early 2025, potentially leading to a larger efficacy study.
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