Bloom Science Reveals Positive Phase 1 Trial Results for BL-001 Showing Significant Weight Loss

Bloom Science, Inc., a biotech firm based in San Diego, has announced promising results from a Phase 1 trial of their investigational oral therapy, BL-001. This study involved 32 adults of varying weights, focusing on the treatment’s efficacy in promoting weight loss. BL-001, designed to mirror the effects of the ketogenic diet, showed significant results in reducing body weight compared to a placebo over a 28-day period.

The trial employed a randomized, double-blind, placebo-controlled method to evaluate the safety, tolerability, and pharmacokinetic properties of BL-001. The treatment group consisted of 24 participants who received BL-001, while the remaining eight were given a placebo. Results indicated a statistically significant level of weight loss in subjects taking BL-001 when compared to the placebo group, with a p-value of 0.0424.

Notably, among individuals characterized as overweight, the weight reduction was even more pronounced. In this subgroup, the treatment achieved a placebo-adjusted weight loss with a statistically significant p-value of 0.0007, translating to a mean body weight change of -2.3%. Additionally, the weight loss between overweight and healthy weight participants who received BL-001 was significant, with an LS mean change of -2.2%. The greatest individual weight loss recorded was 4.9%.

Remarkably, the weight reduction effects persisted beyond the treatment period. About 80% of participants who lost weight during the trial maintained this weight loss two weeks after their final dose. Particularly, those in the highest dosage group continued their weight loss trajectory, witnessing a 3.4% reduction from their baseline weight by the end of the follow-up.

BL-001 also prompted metabolic changes similar to those seen in individuals following a ketogenic diet, such as increased urinary ketones and reduced appetite. The study identified significant shifts in metabolic hormones that regulate appetite and digestion, along with changes in circulating ketone bodies, supporting the drug’s potential.

Louis Licamele, PhD, Chief Development Officer at Bloom Science, expressed optimism about the results, highlighting BL-001 as a potential revolutionary treatment for obesity. The drug aims to offer a safe, naturally inspired alternative that addresses the limitations of current therapies by fostering sustainable weight loss.

Previously, BL-001 demonstrated its ability to emulate the ketogenic diet’s therapeutic effects and prevent seizures in animal models. Following these positive trial outcomes, Bloom Science intends to advance BL-001 to Phase 2 trials targeting obesity and specific neurological disorders like Dravet syndrome in 2026.

BL-001 is considered a pioneering live biotherapeutic product delivered orally, developed to mimic the ketogenic diet's benefits. The ketogenic diet, established in 1921, is a low-carbohydrate, high-fat diet originally intended to treat epilepsy. While effective, the diet can be challenging to maintain, thus BL-001 presents an opportunity for patients to gain its benefits through a more manageable form.

Bloom Science continues to develop therapies targeting metabolic and neurological disorders, leveraging its understanding of the gut-brain axis and microbiome. Their proprietary platform, IrisRx™, underpins their innovative approach to creating new treatments with improved safety profiles. The company remains focused on addressing conditions such as obesity, Dravet syndrome, and other neurological disorders.