Clinical Pipeline

 

Osel’s portfolio consists of two clinical stage products and a preclinical platform, each with unique and selective mechanisms of action.

LACTIN-V

Osel’s LACTIN-V is a live biotherapeutic product addressing women’s health disorders. It incorporates a single species and strain of Lactobacillus that is part of the natural microbiome of healthy women and that has been selected for features that restore health and prevent recurrence of infection. In particular, LACTIN-V fosters the conditions observed in healthy women that combat the pathogenic bacteria and dysbiosis observed in bacterial vaginosis and urinary tract infections. LACTIN-V is delivered vaginally with a proprietary applicator.

Several clinical trials with LACTIN-V have already been completed. 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 Phase 2 clinical studies today.

CBM588

CBM588 is an orally-administered Clostridium butyricum strain with a strong record of safety. Clinical development of CBM588 is targeted to conditions caused by disruption of the human gastrointestinal microbiome, including antibiotic associated diarrhea and Clostridium difficile infection.

In a randomized, double-blinded, placebo-controlled study in adults receiving oral antibiotics as outpatients in the U.S., CBM588 was shown to be safe. The product has also been used safely in all age groups in Japan primarily for diarrheal disorders. Recent nonclinical studies have described novel anti-inflammatory activities that support the use of CBM588 in treating Inflammatory Bowel Disease.

MucoCept Technology Platform

Most viruses enter the body via mucosal surfaces. The natural microbiota at these sites, may neutralize some viral particles before infection of the host can occur. Using a proprietary technology, MucoCept harnesses the human microbiome and enhances it to further virus neutralization. In the current MucoCept platform technology, we have modified a commensal Lactobacillus to express a potent inhibitor of Human Immunodeficiency Virus type 1 (HIV-1). Proof of concept for MucoCept has been demonstrated in animal models.

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