MIYA-BM: Clinical Development Plan

MIYA-BM is an orally-administered LBP that is based on a bacterial strain safely used in Japan for over 40 years.  Clinical development of MIYA-BM is targeted to conditions represented by the disruption of the Human Microbiome of the gastrointestinal tract:

• Clostridium difficile infection (CDI)
• Inflammatory bowel disoders, including “Irritable Bowel Syndrome” (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
• Antibiotic Associated Diarrhea, and other GI conditions

MIYA-BM showed an excellent safety profile in a Phase 2 randomized, double-blinded, placebo-controlled study in adults with receiving oral antibiotics as outpatients.

As the rate and severity of CDI is currently increasing nationwide and accounts for more deaths than all other gastrointestinal infections combined.  Osel plans to conduct Phase 2 and Phase 3 trials and file a Biologic License Application (BLA) with FDA.  Osel is also intends to evaluate the therapeutic potential of MIYA-BM for the treatment of IBS and for inflammatory bowel disease, such as Ulcerative Colitis (UC).

Several clinical trials with LACTIN-V have already been completed. [LINK TO relevant CLINICAL PUBLICATIONS]. These studies have demonstrated the safety of the product, and show that LACTIN-V use is associated with favorable outcomes for patients with bacterial vaginosis and recurrent urinary tract infections. In a seminal study, women who took LACTIN-V and achieved a high level of LACTIN-V colonization had a significant decrease in rUTI (50%) versus those that did not (P<0.01)

LACTIN-V is being further evaluated in a pivotal clinical trial today. [LINK to CLINICAL TRIALS of LACTIN-V].