LACTIN-V Enters Clinical Study to Improve the Success Rate of IVF in Women with Imbalanced Vaginal Microbiomes

MOUNTAIN VIEW, CA (January 17, 2018): Osel, Inc. today announced the first patient has been dosed in a new clinical study launched in collaboration with five Danish fertility clinics and Statens Serum Institute to determine whether LACTIN-V™ can improve the success rate of in vitro fertilization (IVF) for infertile women with abnormal vaginal microbiota (AVM).

The study was based on findings published in Human Reproduction by some of the investigators participating in the trial, demonstrating that women with an abnormal vaginal microbiota undergoing IVF had a significantly lower chance of becoming pregnant (9%) compared to women with a normal vaginal microbiota (44%). High levels of two specific vaginal bacteria (Atopobium vaginae and Gardnerella vaginalis) serve as diagnostic markers of AVM that might cause impaired embryo implantation and subsequent poor reproductive outcome.

Around 20% of all women in fertility treatment have AVM, which can also reside in the upper reproductive tract, i.e., the uterus and the oviducts. Many of these women have no symptoms, so this problem goes unrecognized.

The double-blind, placebo-controlled multi-center trial is designed to determine whether treatment with antibiotic and LACTIN-V improves the reproductive outcomes of IVF patients with AVM. Patients seeking IVF treatment will be screened for AVM and 333 women with abnormal levels will undergo treatment. The trial will include three treatment arms: antibiotic and LACTIN-V; antibiotic alone; and placebo. The primary endpoint is clinical pregnancy rate — fetal heartbeat as observed by ultrasound at the gestational age of 7 weeks.

“We are excited to pursue this important new indication for LACTIN-V with hopes that it can improve the ability to conceive for women facing fertility challenges,” said Peter P. Lee, MD, Chairman of Osel, Inc. “The more we learn about the microbiome, the more we understand its critical role in health. While most of the focus has been on the gut microbiome, it is important for people to be aware that healthy functioning of other aspects of the body is also regulated by bacteria, and that new therapies are emerging designed to treat conditions resulting from disrupted microbiota.”

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 species of Lactobacillus found in yogurt and supplements (typically L. casei, L. acidophilus or L. bulgaricus).  Unlike probiotics, LACTIN-V is being developed as a new type of drug, designated as a Live Biotherapeutic Product by the FDA. LACTIN-V is also currently under study in a Phase 2b trial to determine its ability to prevent the recurrence of bacterial vaginosis following antibiotic therapy.

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. The company is a pioneer in the field of LBPs. 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. 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.