Osel, Inc. Comments on New Study Showing Role of Vaginal Microbiome in Women’s Health

MOUNTAIN VIEW, CA (July 21, 2016): Osel, Inc. today commented on findings presented by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) consortium of South African and North American researchers at the International AIDS 2016 Conference, detailing the role played by vaginal dysbiosis in the high rates of sexual transmission of HIV to women from men. The researchers found that an imbalance of certain bacteria in the vagina was associated with both higher transmission of HIV and a reduction in the efficacy of an antiviral drug used to prevent HIV infection. In their presentation, the scientists concluded that an important step in preventing the spread of HIV infection is restoring and maintaining a healthy vaginal microbiome in those affected by vaginal dysbiosis.

“The CAPRISA study highlights the critical role that a healthy vaginal microbiome plays in protecting women from bacterial and viral infection, and stresses the need for an effective solution to vaginal dysbiosis,” said K.T. Moortgat, Chief Executive Officer of Osel, Inc.  “We believe the successful development of a live biotherapeutic product designed to restore the healthy vaginal microbiome following antibiotic treatment has the potential to make a valuable contribution to women’s health, as underscored by this important new study.”

Currently the only FDA-approved treatments for a prevalent vaginal dysbiosis, called bacterial vaginosis, are antibiotics. These antibiotics do interfere with the unwanted pathogenic bacteria, but do not address the underlying problem of low vaginal Lactobacillus levels.  Thus, following antibiotic treatment, there is a high rate of recurrence of the pathogens (up to 58% within a year*). There are no products approved by FDA to prevent recurrence of bacterial vaginosis.

Osel is conducting a Phase 2b clinical study of its lead product candidate LACTIN-V™ to prevent the recurrence of bacterial vaginosis, following antibiotic therapy. LACTIN-V is a live biotherapeutic product that contains a naturally occurring Lactobacillus that is part of the vaginal microbiome of healthy women, a single strain of Lactobacillus crispatus.

LACTIN-V™ delivers a Lactobacillus unique to the healthy human vaginal microbiome with properties and adaptations specific to this microbiome.  This and other vaginal Lactobacillus  species are entirely distinct from those of probiotic yogurt species of Lactobacillus (typically L. casei, L. acidophilus or L. bulgaricus).  Further differentiating LACTIN-V, as a live biotherapeutic product it is regulated by the FDA and is undergoing clinical trials for safety and efficacy like other pharmaceuticals. In contrast, probiotics are food additives and lack similar regulatory requirements or proof of efficacy.

In a press release this week, Professor Salim S. Abdool Karim, Director of CAPRISA and leader of the research team commented: “Based on our results, implementing a combination of evidence-based targeted interventions to break the cycle of HIV transmission while effectively treating bacterial vaginosis could enhance HIV prevention in women in the highest HIV-burden in the world.”

For more detail on the Phase 2 trial of LACTIN-V, and information on how to participate, please visit https://clinicaltrials.gov/ct2/show/NCT02766023?term=LACTIN-V&rank=1.

About Bacterial Vaginosis

Bacterial vaginosis (BV) is the most common vaginal infection in women ages 15-44, according to the Centers for Disease Control and Prevention, with a prevalence of over 29%. While infected women often report no symptoms, they are at markedly higher risk for other sexually transmitted disease and when pregnant, have higher rates of pre-term birth. The approach to treating bacterial vaginosis has not changed in several decades, and recurrence rates are high even following successful treatment of the initial infection.

About Osel, Inc.

Osel, Inc., a privately held biotechnology company, is focused on the development and commercialization of a portfolio of Live Biotherapeutic Products (LBPs) that prevent or treat medical conditions resulting from a disruption of the human microbiome. In 2003, Osel became one of the first companies to receive U.S. Food and Drug Administration authorization to test a commensal bacterium as a live bacterial therapeutic, and the company is a pioneer in the field of LBPs. The company’s proprietary approach identifies differences between healthy and disease-related microbiomes and leverages beneficial microbes to treat problematic disruptions or dysbioses. Osel’s approach repopulates the disrupted microbiome with beneficial bacteria that help restore a healthy and protective microbiota.

Osel’s primary focus is women’s health, with initial areas of interest including recurrent urinary tract infections and bacterial vaginosis. Osel is based in Mountain View, CA. For more information, please visit the company’s website at https://oselinc.com

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* Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, et al. (2006) High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 193: 1478–1486.