Our Drug Development Project

We are progressing a novel drug combination, Brite-1, through clinical trials to treat obesity and related indications

This project aims to develop a novel pharmaceutical treatment, known as Brite-1, to treat obesity and related disorders, such as diabetes and MASH (Metabolic Dysfunction Associated with Steatohepatitis). Drug repositioning is a drug-discovery strategy that relies on existing information to recommend an existing drug for a new indication based on clinical data or biological experiments. We used various bioinformatic approaches and preclinical studies to identify two drugs that could be repositioned and combined to treat weight-related disorders. These bioinformatic approaches included exploring potential drug-interactions, target distribution, genome-wide association studies, and preclinical and clinical safety and efficacy results. We focussed on identifying a combination of agents that would provide a durable response by reducing food intake and increasing energy expenditure and complement existing GLP-1/incretin related therapies.

Preclinical data reveals treatment with the drug combination results in significant reductions in food intake and body weight. Genome-wide association studies show the proposed drug targets have a significant association (P<5 × 10−8) with body weight regulation. Clinically, up to 15% weight loss is anticipated after once daily, chronic oral-dosing. Existing long term clinical data for the individual drugs indicates each is well-tolerated as monotherapy. A pre-IND meeting with the FDA was supportive of studying this combination in clinical trials without the need for additional preclincal testing. A patent application has been filed that protects the combination therapy for treating obesity and related indications. .

Brite Therapeutics, Inc. is looking for investors and strategic partners in developing our novel drug combination, Brite-1, to treat obesity, fatty liver disease, and related metabolic complications. Extensive preclinical and clinical data exist for the individual compounds and it is our goal to examine how the combination, Brite-1, behaves in the clinic. We are open to discussing partnerships and investments to advance this therapy into Phase 1 clinical trials and beyond. Please contact us to discuss your interests..

Brite-1 Partnership