1ST Biotherapeutics, Inc., announced positive results from a Phase 1 trial of FB-101, an investigational compound being studied to treat Parkinson’s disease and other neurodegenerative disorders. FB-101 inhibits c-Abl (Abelson tyrosine kinase), a protein that plays a role in the toxic buildup of alpha-synuclein.
The randomized, double-blind, placebo-controlled study was conducted in 24 healthy subjects and assessed the safety, tolerability, and pharmacokinetic profile of a single ascending oral dose of FB-101. The compound was well-tolerated and showed no significant safety signals. FB-101 effectively crossed the blood-brain barrier as measured by subjects’ cerebrospinal fluid.
1ST Biotherapeutics plans to move FB-101 into a multiple ascending dose trial by the end of 2022. The results from that study will be used to determine the correct dose for evaluating the efficacy and safety of FB-101 in patients with Parkinson’s. 1ST Biotherapeutics will also begin clinical testing of FB418, which inhibits both c-Abl and LRRK2, as a potential treatment for Parkinson’s disease early next year.