Neurizon files IND application to support HEALEY ALS platform trial
- Neurizon has submitted an IND application to the FDA for its lead candidate, NUZ-001, targeting ALS.
- The IND includes comprehensive data from animal and human studies, pharmacokinetics, toxicology, and manufacturing.
- The FDA has 30 days to review the application, which is crucial for starting a Phase 2/3 trial.
- Pending approval, patient enrollment in the HEALEY ALS Platform Trial is expected to begin in H1 2025.
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Vandria begins phase 1 trial of VNA-318 for CNS disorders
- Vandria has dosed the first subjects in its phase 1 trial of VNA-318, a brain-penetrant mitophagy inducer.
- The trial is a randomized, double-blind study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy male subjects.
- VNA-318 targets age-related diseases, showing potential in Alzheimer's and Parkinson's disease models.
- A $32M Series A funding supports this trial, with plans for phase 1b/2a trials in early 2026.
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NMD Pharma publishes new data on ClC-1 inhibition in Charcot-Marie-Tooth
- NMD Pharma published data in the Annals of Clinical and Translational Neurology on ClC-1 inhibition's role in Charcot-Marie-Tooth (CMT) disease.
- The ESTABLISH1 study confirmed neuromuscular junction dysfunction in CMT patients, correlating with disease severity.
- Preclinical studies showed that ClC-1 inhibitor NMD670 improved muscle function in CMT mouse models.
- NMD Pharma has initiated a Phase 2 clinical trial for NMD670 in CMT patients as of November 2024.
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Health Canada approves XEOMIN for post-stroke lower limb spasticity
- Health Canada has approved XEOMIN (incobotulinumtoxinA) for treating post-stroke lower limb spasticity in the ankle and foot in adults.
- XEOMIN can now be administered in up to 600 units for combined upper and lower limb treatment, allowing for tailored patient care.
- The approval is based on data from the Japanese J-PLUS study, which demonstrated XEOMIN's efficacy in treating spasticity in stroke survivors.
- Canada is the third country to approve this treatment, following the United Kingdom and Switzerland.
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NeuroMetrix to be acquired by electroCore
- NeuroMetrix has entered into a definitive merger agreement with electroCore, expected to close in Q1 2025.
- NeuroMetrix shareholders will receive net cash and a contingent value right (CVR) per share.
- The CVR includes potential proceeds from the DPNCheck platform divestiture and royalties on Quell products.
- The transaction is subject to NeuroMetrix shareholder approval and other customary conditions.
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