Bloom Science Completes Successful Pre-IND Meeting with the FDA for BL-001 Clinical Trial to Treat Dravet Syndrome
SAN DIEGO, Calif., January 4, 2023 — Bloom Science, Inc., a clinical-stage biotechnology company developing novel medicines for neurological diseases and conditions, successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) and gained alignment on the initial Phase 1 clinical trial of its oral, live biotherapeutic product (LBP), BL-001, for the treatment of patients with Dravet syndrome.
Dravet syndrome is a developmental and epileptic encephalopathy, a severe form of epilepsy with frequent and difficult to treat seizures that begin in infancy or early childhood and causes developmental challenges. Bloom’s BL-001 LBP is reverse translated from positive clinical outcomes associated with the ketogenic diet in treating refractory epilepsy.
Bloom presented to the FDA its planned Phase 1 study design, including the proposed patient population. The FDA aligned with the source and characterization of Bloom’s product strains, provided patient criteria guidance and agreed that no additional nonclinical studies are required to initiate the Phase 1 study in healthy volunteers.
BL-001 is set to enter the clinic, with a phase 1 clinical trial in early 2023.
ABOUT BLOOM SCIENCE
Bloom Science is a clinical-stage biotechnology company on a mission to bring transformative live biotherapeutic products (LBPs) to underserved patients with rare or complex neurological diseases who have not adequately responded to existing therapies. Bloom is taking a fundamentally different path to developing medicines by harnessing our expanding insight into how the gut microbiome modulates key processes in the immune system, nervous system and brain. Bloom has developed a platform to investigate how changes in the gut microbiome influence brain biochemistry and immune system activity that it can leverage to develop multi-functional therapeutics addressing multi-pathway driven neurological disorders. Learn more: https://bloomscience.com/