Bloom Science has concluded enrolment in all four cohorts of healthy adult subjects in its Phase l trial of BL-001 for the treatment of Dravet syndrome, a rare paediatric epilepsy that impacts individuals throughout their lives.
The randomised, double-blind, placebo-controlled, single-centre, multiple ascending dose trial has enrolled 32 healthy adult subjects.
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The participants across the four dose cohorts have been randomised in a 3:1 ratio to receive BL-001 and placebo.
The primary objective of the trial is to assess the safety and tolerability of BL-001, an orally administered live biotherapeutic product reverse translated from the positive clinical outcomes related to the ketogenic diet in treating refractory epilepsy.
The trial will also examine the effects of BL-001 on the gut microbiota and pharmacodynamic biomarkers.
Currently conducted in Europe, the trial expects to provide topline results including safety and tolerability by the third quarter of this year.
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By GlobalDataAfter completing the trial, Bloom plans to commence a Phase ll study in Dravet syndrome patients.
Bloom Science founder and CEO Christopher Reyes said: “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.”
