A Phase 2a clinical trial of IFB-088, a novel drug candidate for bulbar-onset amyotrophic lateral sclerosis (ALS), has shown promising results in safety and potential treatment effectiveness. The study, conducted by InFlectis BioScience, involved 51 patients with this severe ALS subtype.
The primary objective of the randomized, double-blind, placebo-controlled study was to assess the safety of IFB-088. Researchers found the drug was well-tolerated, meeting the study's primary endpoint. Additionally, preliminary efficacy data suggested a potential slowdown in functional decline among treated patients.
In the per-protocol population, patients receiving IFB-088 experienced a slower functional decline compared to the placebo group, with a statistically significant difference in ALSFRS score progression. The treatment also demonstrated engagement with integrated stress response and oxidative stress pathways, supporting the underlying medical hypothesis.
Bulbar-onset ALS, which affects approximately 30% of ALS patients, is characterized by rapid progression and significant impairment of speech and swallowing functions. Current treatment options remain limited, making this research potentially significant for patient care.
The study's findings validate previous preclinical research and position IFB-088 for potential further development. InFlectis BioScience is now seeking global partners to advance the drug's clinical progression and explore its potential in treating neurological conditions.
