Osel News
 

PRESS RELEASE

FEBRUARY 03, 2021 

Osel Obtains Exclusive License from Danish Research Consortia for IP Related to Osel’s LACTIN-V in Women Undergoing In-Vitro Fertilization

— LACTIN-V, a live biotherapeutic product, previously demonstrated clinical efficacy in reducing bacterial vaginosis recurrence  —

February 03, 2021 — Mountain View, Calif. — Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced that it has entered into a definitive agreement with a consortia comprising Aarhus University, Skive Hospital and Statens Serum Institut of Denmark, and obtained the exclusive worldwide license to inventions resulting from an investigator-initiated Phase 2 trial of Osel’s investigational LBP, LACTIN-V, in women undergoing in-vitro fertilization (IVF). Financial terms were not disclosed.

Osel is developing LACTIN-V, a proprietary formulation of Lactobacillus crispatus being studied in IVF, in addition to bacterial vaginosis (BV) and pre-term birth. Last year, Osel and colleagues published data in The New England Journal of Medicine demonstrating that LACTIN-V significantly reduced the recurrence of BV versus placebo in a Phase 2b trial.

“Dysbiosis, or disruption of the vaginal microbiome, can lead to many problems in women’s health including BV and decreasing the success rate of IVF,” said Peter P. Lee, MD, Founder and Executive Chairman of Osel. “LACTIN-V, which contains the protective vaginal bacterial strain L. crispatus CTV-05, could help promote a healthier vaginal microbiome for IVF.”

Under the agreement, the ongoing Phase 2 IVF trial is being conducted at four fertility clinics in Denmark and led by Professor Peter Humaidan, MD, Aarhus University and Skive Regional Hospital. The primary endpoint of the trial is clinical pregnancy at seven weeks post-embryo transfer in women with documented abnormal vaginal microbiota, which lowers the probability of successful IVF.

“The vaginal microbiome and its importance for fertility is an intriguing new field of research. In the near future we hope to be able to define the most optimal vaginal microbiome – and importantly, to be able to modify the abnormal to normal,” said Professor Humaidan. “The ultimate goal of our research is to improve success rates of not only IVF, but also spontaneous pregnancy.”

“LACTIN-V holds promise as the first treatment to increase the possibility of pregnancy from IVF, especially in women with vaginal dysbiosis,” said Thomas Parks, PhD, Director of Product Development at Osel. “While the trial’s progress was impacted by COVID-19, we expect to complete enrollment by the end of 2021/early 2022.

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.

Media Contact
Osel:
Chris Lieu
Bioscribe, Inc.
Tel: (310) 528-7486
Email: chris@bioscribe.com

Danish Consortia:
Morten Faester
SSI
Tel: +45 6137 0414
Email: mofr@ssi.dk

PRESS RELEASE

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.

Contact:
Mary Coyle
Bioscribe
917-975-6615
mary@bioscribe.com