MAY 13, 2020
Osel’s Live Biotherapeutic Product Demonstrates Efficacy in Phase 2b Study of Bacterial Vaginosis
— LACTIN-V is the first live biotherapeutic product to demonstrate significant efficacy in a randomized double-blind, placebo-controlled Phase 2b trial conducted in the United States —
— Results published in the New England Journal of Medicine —
May 13, 2020 — Mountain View, Calif. — Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced clinical data showing that the company’s LACTIN-V LBP significantly reduced the recurrence of bacterial vaginosis (BV) vs. placebo in a Phase 2b trial. Results were published in the New England Journal of Medicine: “Randomized Trial of LACTIN-V to Prevent Recurrence of Bacterial Vaginosis.” The study was conducted with the support of the National Institute of Allergy and Infectious Diseases (NIAID), contracts HHSN2722013000141 and HHSN27200007.
“We believe this study represents a landmark in the microbiome field, particularly for women’s health,” said Thomas Parks, Director of Product Development at Osel.
BV is one of the most frequent vaginal infections and affects approximately 30% of reproductive-aged women in the U.S. While antibiotic treatment is effective in some women, up to 75% relapse within three months. BV has been associated with increased risk of acquiring and spreading sexually transmitted infections, including HIV, as well as increased risk for premature birth.
LACTIN-V is a topically-administered LBP containing the protective vaginal bacterial strain Lactobacillus crispatus CTV-05, which helps combat the pathogenic bacteria and dysbiosis observed in BV and urinary tract infections. The product is designed to promote a healthy L. crispatus-dominant bacterial community following standard antibiotic treatment with vaginal 0.75% metronidazole (MetroGel®).
In the trial, 228 women were randomized to receive either LACTIN-V or placebo. At the 12-week visit in the intent-to-treat population, BV recurrence was significantly less in women treated with LACTIN-V (30%) compared to placebo (45%) (p=0.01). L. crispatus CTV-05 was detected in 79% of the women treated with LACTIN-V at the 12 week visit. The treatment benefit vs. placebo persisted through an additional 12 weeks following the last dose, despite over half of the enrolled patients having been previously diagnosed with BV five or more times. Adverse events were similar in both groups.
“The initial indication for LACTIN-V is for the prevention of BV recurrence, which tens of millions of women around the world suffer from each year,” said principal investigator and first author Craig R. Cohen, MD, Professor of obstetrics, gynecology & reproductive sciences at the University of California San Francisco. “LACTIN-V is the first major advance to treat women with BV since the introduction of antibiotics to treat this condition. It also has the potential to be an effective intervention to prevent HIV infection and preterm birth through optimization of the vaginal microbiome.”
Peter P. Lee, founder and executive chairman of Osel, added, “We currently have ongoing LACTIN-V clinical studies for in vitro fertilization (IVF) and preterm birth.”
About Osel, Inc.
Osel, Inc., a privately held biopharmaceutical company based in Mountain View, California, is focused on the development and commercialization of a portfolio of live biotherapeutic products (LBPs) to prevent or treat medical conditions resulting from disruption of the human microbiome (dysbiosis). The company is a pioneer in the field of LBPs, with a primary focus in women’s health. While many current microbiome treatments involve microbial transplants that are collected and processed from donor pools, Osel focuses on rigorously selected single strain products that are highly reproducible, scalable, and safe.