BL-001 / Bloom Science - LARVOL DELTA

A Phase 1b Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple Dose Safety and Tolerability Study of Daily Dosing of BL-001 for 12 Weeks in Adults with Obesity (ANZCTR) - P1 | N=48 | Active, not recruiting | Sponsor: Bloom Science Australia Pty Ltd | Not yet recruiting ➔ Active, not recruiting | Initiation date: Feb 2026

Enrollment closed • Trial initiation date • Genetic Disorders • Metabolic Disorders • Obesity

Bloom Science Initiates Phase 1b Obesity Trial of BL-001, Advancing a Differentiated Approach Beyond GLP-1 (PRNewswire) - "Bloom Science...announced that the first patient has been dosed in its Phase 1b clinical trial evaluating BL-001 in adults with obesity. The Phase 1b study (BL-001-1201) is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and weight loss effects of daily oral BL-001 administered for 12 weeks in adults with obesity. The study will enroll up to 48 participants across two clinical sites in Australia."

Trial status • Obesity

A Phase 1b Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple Dose Safety and Tolerability Study of Daily Dosing of BL-001 for 12 Weeks in Adults with Obesity (ANZCTR) - P1 | N=48 | Not yet recruiting | Sponsor: Bloom Science Australia Pty Ltd

New P1 trial • Genetic Disorders • Metabolic Disorders • Obesity

Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals (PRNewswire) - P1 | N=32 | NCT05818306 | Sponsor: Bloom Science | "The overall treatment effect of BL-001 on weight loss (all treated BL-001 (n=24) vs Placebo (n=8)) was statistically significant (p=0.0424; MMRM, mixed model repeated measures) over the 28-day treatment period. Previously reported clinical trial results showed that BL-001 was well tolerated with minimal adverse events....The percent weight change of the BL-001 treated overweight (BMI >= 25) subjects vs all subjects who received placebo (pooled) is statistically significant (p=0.0007, LS mean change -2.3% body weight change). The percent weight change between overweight and healthy weight individuals treated with BL-001 is also statistically significant (p=0.0003, LS mean change -2.2% body weight change). The highest recorded weight loss was 4.9%....The latest analysis also supports Bloom's plans to initiate a Phase 2 study in an obese population in 2026."

New P2 trial • P1 data • Obesity

Selection of Lead Candidate Bacteria for BL-001, a Live Biotherapeutic Product in Development for the Treatment of Neurological Indications (AES 2024) - "From this data we were able to select the strains that exhibited the strongest desirable phenotypes in vitro and in vivo and establish that this combination of bacteria with a high degree of certainty would be safe for human consumption. In conclusion, the strain combination selected by the IrisRxTM platform methodology to constitute BL-001 was found to be suitable for proceeding to trials in human."

CNS Disorders • Epilepsy • Inflammation

Safety, Tolerability, and Strain Kinetics of BL-001, an Orally Delivered Live Biotherapeutic Product, in a Phase 1 Study of Healthy Volunteers (AES 2024) - P1 | "BL-001 demonstrated a favorable safety profile and was well tolerated with no Serious Adverse Events. There were 37.5% of participants (9/24) in the treated group with treatment-emergent adverse events compared to 25% in the placebo group (2/8). The tolerability of the treatment was largely acceptable, with 21% of participants (5/24) experiencing a treatment-related AE during the study."

Clinical • P1 data • CNS Disorders • Epilepsy • Fatigue • Gastrointestinal Disorder

Reverse Translational Validation of Anti-epileptic Effect of Prototype BL-001 in a Preclinical Seizure Model from a Phase 0 Trial in Healthy Volunteers (AES 2024) - "All doses of BL-001 strains administered to healthy volunteers were shown to be safe and well tolerated with positive strain kinetics observed and overall microbiome diversity preserved. More specifically, the BL-001 component strains showed significant changes while minimizing any off-target effects in the rest of the microbiome. Seizure testing in mice receiving fecal microbiota transplant of BL-001 from dosed human stool samples provided seizure protection and demonstrates therapeutic potential of BL-001."

Preclinical • CNS Disorders • Epilepsy • Fatigue • Gastrointestinal Disorder

The Safety, Tolerability, and Strain Kinetics of BL-001, an Orally Delivered Live Biological Product, in Healthy Volunteers (AAN 2024) - P1 | "The tolerability of the treatment was largely acceptable with 21% of subjects (5/24) experiencing a treatment related AE during the study. Favorable strain kinetics were observed with BL-001 component strains increasing in a dose dependent manner."

Clinical • CNS Disorders • Epilepsy • Gastrointestinal Disorder

A Phase Ia Safety and Tolerability Study of BL-001 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bloom Science | Recruiting ➔ Completed

Trial completion

Bloom Science Completes Enrollment in Phase 1 Trial of BL-001, a First-in-Class Therapy Being Developed for Dravet Syndrome (PRNewswire) - "Bloom Science...today announced that the company has completed enrollment in all four cohorts of healthy adult participants as part of its Phase 1 clinical trial. Bloom is developing BL-001 for Dravet syndrome, a rare pediatric epilepsy that significantly impacts individuals throughout their lifetime. 'The initial dosing and completion of enrollment of our Phase 1 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'....The Phase 1 trial is being conducted in Europe. Following successful completion of the Phase 1 trial, Bloom intends to initiate a Phase 2 study in patients with Dravet syndrome."

Enrollment closed • New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • Epilepsy

A Phase Ia Safety and Tolerability Study of BL-001 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bloom Science

New P1 trial