Clinical-stage biotech company Bloom Science Inc announced on Tuesday that that BL-001, an investigational oral therapy designed to replicate the positive effects of the ketogenic diet, demonstrated statistically significant placebo-adjusted weight loss at 28 days in a Phase 1 trial of 32 healthy adults ranging from healthy weight to overweight.

The randomised, double-blind, placebo-controlled trial assessed safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BL-001 when dosed once-daily (QD).

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) was 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 was also statistically significant (p=0.0003, LS mean change -2.2% body weight change). The highest recorded weight loss was 4.9%.

Additionally, 80% of the subjects who experienced weight loss during BL-001 treatment maintained a weight loss compared to their baseline body weight two weeks after their last dose. Of these, 100% of the overweight subjects receiving the highest dose continued to lose weight, resulting in 3.4% weight loss by the end of the two-week follow-up period.