Bloom Science, a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis, has completed enrolment in all four cohorts of healthy adult participants as part of its Phase I clinical trial.
Bloom is developing BL-001 for Dravet syndrome, a rare paediatric epilepsy that significantly impacts individuals throughout their lifetime.
The study
Bloom’s BL-001 is an orally administered Live Biotherapeutic Product reverse translated from the positive clinical outcomes associated with the Ketogenic Diet in treating refractory epilepsy.
The Phase I study of BL-001 is a randomised, double-blind, placebo-controlled, single-center, multiple ascending dose study in healthy volunteers.
A total of 32 healthy adult volunteers have been enrolled, across four dose cohorts and randomised in a three to one ratio of BL-001 to placebo.
The primary objective of this study is to evaluate the safety and tolerability of BL-001. The trial will also evaluate the effects of BL-001 on the gut microbiota and pharmacodynamic biomarkers.
Official comment
“The initial dosing and completion of enrolment of our Phase I clinical trial for BL-001 represents a huge milestone for Bloom Science and for the epilepsy community as we advance our clinical development program for Dravet syndrome and other developmental epilepsies,” said Dr Christopher Reyes, Founder and CEO of Bloom Science. “We believe BL-001 has the potential to provide patients with the same neurological and seizure relief benefits of the Ketogenic Diet, but in the form of a simple daily oral therapeutic. Our preclinical studies have shown that BL-001 possesses strong potential to reduce neuronal hyperexcitability, control seizures and overcome drug-resistance with significantly fewer side effects compared to other drugs on the market. We are committed to developing a more holistic therapy for patients with Dravet syndrome that not only reduces seizure burden, but also treats significant comorbidities.”
Looking forward
The Phase I trial is being conducted in Europe. Following successful completion of the Phase I trial, Bloom intends to initiate a Phase II study in patients with Dravet syndrome.
