CervoMed Inc. (NASDAQ: CRVO) has been awarded the Prix Galien USA 2024 prize in the Best Startup category by the Galien Foundation, recognizing the company's innovative work toward developing a treatment for Dementia with Lewy bodies (DLB). The award acknowledges the advancements made with neflamapimod, an investigational drug currently in Phase 2b clinical trials. Topline results from the RewinD-LB Phase 2b trial are anticipated in December 2024.
Significance of the Award
The Prix Galien USA Best Startup award is given to therapeutics-focused life science companies demonstrating outstanding innovation before receiving their first product approval. CervoMed was selected from 43 nominees by a committee of pharmaceutical industry leaders. John Alam, MD, CEO of CervoMed, stated that the award implicitly recognizes the potential breakthrough a positive outcome in the RewinD-LB study would represent, given the unmet need in DLB treatment.
The Unmet Need in Dementia with Lewy Bodies
DLB is the third most common degenerative brain disease, affecting approximately 700,000 individuals in both the U.S. and EU. Patients experience a build-up of Lewy bodies, protein deposits in the brain's nerve cells, leading to cognitive and motor function decline. Currently, there are no FDA or European Medicines Agency-approved treatments specifically for DLB. The standard of care, cholinesterase inhibitors, offers only transient cognitive improvement and does not address motor symptoms.
Neflamapimod: A Potential Therapeutic Approach
Neflamapimod is an investigational, orally administered, brain-penetrant small molecule that inhibits the alpha isoform of p38MAP kinase. Preclinical studies have shown that neflamapimod can reverse synaptic dysfunction, particularly in the basal forebrain cholinergic system, an area significantly impacted in DLB. Phase 1 and Phase 2 clinical studies, involving over 300 participants, have indicated that neflamapimod is generally well-tolerated.
Results from the AscenD-LB Phase 2a clinical study demonstrated significant improvements in dementia severity, as measured by the Clinical Dementia Rating Sum-of-boxes (CDR-SB), and functional mobility, assessed by the Timed Up and Go Test (TUG), compared to placebo. A cognitive test battery also showed improved results at the highest dose evaluated. The ongoing RewinD-LB Phase 2b study is a randomized, 16-week, double-blind, placebo-controlled trial involving 159 patients with early-stage DLB. The primary endpoint is the change in CDR-SB, with secondary endpoints including the TUG test, a cognitive test battery, and the Clinician’s Global Impression of Change. Patients completing the initial 16-week study are continuing into a 32-week open-label extension.
