Science

Unlocking new therapeutic pathways for metabolic and neurological health

Deep Pipeline of Novel Therapeutic Opportunities

At Bloom Science, we are taking a fundamentally different approach to developing medicines by harnessing our deep knowledge about how the gut microbiome modulates key processes in metabolism, the immune system, nervous system and brain. Our programs and research areas include:

  • Obesity and Metabolic syndromes
  • Dravet syndrome and Developmental Epileptic Encephalopathies (DEEs)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Neuropsychiatric Conditions
  • Alzheimer’s

Our Pipeline

Bloom is building an obesity and CNS franchise anchored by BL-001, an oral, once-daily live biotherapeutic that reverse-engineers ketogenic biology into a scalable medicine.

BL-001 demonstrated Phase 1 safety and tolerability, statistically significant placebo-adjusted weight loss, and metabolic engagement consistent with ketogenic pathway activation.

The program is now advancing into:

• A 12-week randomized, placebo-controlled Phase 1b study in obesity
• An open-label study in Developmental & Epileptic Encephalopathies (DEEs)

These dual programs are designed to validate persistence, durability, and translational relevance across metabolic and neurological disease.

BL-001: Reverse Engineering of the Ketogenic Diet

BL-001 is an oral live biotherapeutic product designed to translate the therapeutic effects of ketogenic biology into a scalable, pharmaceutical-grade therapy. In Phase 1 clinical evaluation, BL-001 demonstrated proof of mechanism, favorable tolerability, and statistically significant metabolic effects. The program is advancing into further clinical studies in obesity and Developmental & Epileptic Encephalopathies (including Dravet syndrome).

100 years of research and clinical experience has shown that the ketogenic diet, a metabolic intervention, results in significant clinical outcomes

Why Ketogenic Biology

For over a century, the ketogenic diet has demonstrated powerful clinical effects across epilepsy and metabolic disease. Despite its efficacy, the diet remains difficult to sustain long term.

BL-001 is designed to replicate the key metabolic and neurochemical effects of ketogenic biology — without dietary restriction — enabling durable, maintenance-ready therapy.

1920s

Early Discoveries

In the 1920s, the ketogenic diet was first introduced as a treatment for epilepsy, showing promising results in reducing seizure frequency in patients.

1970s

Revival in Obesity Research

The 1970s saw a resurgence of interest in the ketogenic diet as a potential intervention for obesity, with studies exploring its impact on weight loss and metabolic health.

1990s

Scientific Validation

By the 1990s, scientific research began to validate the ketogenic diet’s efficacy, leading to increased adoption in both clinical and therapeutic settings.

2018

Microbiome Connections

Prof. Elaine Hsiao at UCLA showed that the ketogenic diet operates through the microbiome and that specific species of commensal bacteria could replicate the therapeutic effect in preclinical seizure models.

Overview of BL-001 Development and Data Supporting Replicating Ketogenic Diet

Early Discovery

Platform and Candidate Selection
  • Bloom builds IrisRx platform
  • Screens for therapeutic candidates

Pre-Clinical

Scientific Validation
  • Bloom confirms and expands anti-epileptic effect of BL-001
  • Development of BL-001

Phase 0

Scientific Validation

Performed reverse FMT of patient samples into same preclinical animal models → confirmed anti-epileptic effect

Phase 1

Healthy Volunteers
  • Double blind placebo controlled
  • No SAEs reported
  • Mild to moderate TEAEs similar to those expected from someone starting the KD

Phase 1

Significant Clinical Response
  • Dose-Dependent Ketogenic Metabolic Changes
  • Treatment with BL-001 results in statistically significant weight loss in overweight subjects (BMI between 25-30)

Bloom Science is developing oral live biotherapeutics that engage ketogenic and GABAergic pathways via the gut-brain axis, translating ketogenic biology into scalable, pharmaceutical-grade medicines.

This interplay occurs through various pathways, including neural, metabolic, hormonal, and immunological mechanisms. Research has shown that changes in the composition of the gut microbiome is linked to neurological processes, metabolism and brain function.

We investigate how changes in the gut microbiome impact pathways and key processes in the nervous system, metabolic system, immune system and brain.

What is the gut microbiome?
The gut microbiome refers to an entire population of microorganisms that colonize the gut. In addition to helping us digest food and providing important nutrients to our bodies, these organisms also play a role in metabolic, immune and inflammatory processes which have an impact on our health and protecting against disease.
What is a Live Biotherapeutic Product (LBP)?
A live biotherapeutic product is a biological medicinal product that contains live microorganisms, such as bacteria, that is suitable for the prevention, treatment or cure of a disease. LBPs take advantage of the synergistic relationship between bacteria and our bodies, specifically how they can affect different systems. Our LBPs are formulated in the form of a simple daily oral product, ensuring that all individuals can readily access the therapeutic advantages of our treatments.
What is the gut-brain axis?

The gut and brain connect via a network of pathways known as the gut–brain axis. This link between the gut and the brain influences multiple pathways and processes including digestion, immune system activities, mood, cognition, mental health and age-related mechanisms.