Osaivax Announces Positive Phase III Results for Lactobacillus crispatus Live Biotherapeutic Capsule in Reducing Recurrence of Bacterial Vaginosis

Dec 13, 2023 11:44 CST Updated 11:44

On December 13, 2023, Suzhou Ousai Micro Biopharmaceutical Technology Co., Ltd. announced today that its investigational National Class 1 Biological New Drug—Live Lactobacillus crispatus Vaginal Capsules—has completed unblinding and preliminary statistical data analysis of its Phase III clinical trial. The results demonstrated that the clinical trial met both primary and secondary endpoints.

“Lactobacillus crispatus Live Bacterial Capsules for Vaginal Administration is a novel Live Biotherapeutic Product (LBP) designed to restore a healthy vaginal microbiota using Lactobacillus crispatus, thereby reducing and preventing the recurrence of vaginal infections.”

This Phase III clinical study is a multicenter, randomized, double-blind, placebo-controlled trial. The live bacterial capsules used contain the natural strain of *Lactobacillus crispatus* (Lc262-1) isolated from the vagina of healthy Chinese women. A total of 320 patients with bacterial vaginosis (BV) were enrolled. After 7 days of combined treatment with oral metronidazole and either the live *Lactobacillus* vaginal capsules or placebo, those who achieved cure were followed up for three months.

Statistical results demonstrated that the experimental group achieved superiority over the placebo group in both primary and secondary clinical endpoints, with statistically significant differences between the two groups. Regarding safety, there was no difference in the incidence of adverse events and adverse reactions between the experimental group and the placebo group.

Professor Liu Zhaohui from Beijing Obstetrics and Gynecology Hospital, Capital Medical University, who serves as the principal investigator of this study and Deputy Leader of the Infection Collaboration Group under the Chinese Society of Obstetrics and Gynecology, Chinese Medical Association, stated: “Preventing recurrence is a critical component in the treatment of gynecological infections. In China, there are over 70 million clinical outpatient visits for bacterial vaginosis (BV) annually, with a recurrence rate as high as 60% within 12 months post-treatment, while currently available effective interventions remain very limited. This Phase III clinical trial has effectively validated the efficacy of Lactobacillus crispatus in suppressing BV recurrence, providing patients with a novel therapeutic option.”

“Lactobacillus crispatus vaginal live biotherapeutic capsules are a novel Live Biotherapeutic Product (LBP) designed to restore healthy vaginal microbiota using Lactobacillus crispatus, thereby reducing and preventing the recurrence of vaginal infections,” stated Dr. Liu Yang, Co-founder and Chief Scientist of Suzhou Ousai Microbiology. “This Phase III clinical trial is the first globally registered Phase III trial conducted under rigorous clinical design to evaluate the efficacy of vaginal Lactobacillus crispatus in reducing the recurrence rate of bacterial vaginosis (BV), with encouraging observational data. Our team will continue to advance steadily in new drug development and expand our pipeline of live biotherapeutic products.”

About Live Lactobacillus crispatus Vaginal Capsules

Vaginal Lactobacillus crispatus Capsules are an innovative biologic drug developed by Suzhou Ousai Microtech, which restores vaginal microecological balance by enabling the colonization and proliferation of live Lactobacillus crispatus in the patient’s vagina.

*Lactobacillus crispatus* is the most prevalent and dominant bacterial species in the vaginal microbiota of healthy women of reproductive age in China. The presence and enrichment of *L. crispatus* in the vaginal environment are considered a hallmark of a healthy vaginal microbiome. *L. crispatus* inhibits the growth of other microorganisms and prevents various gynecological reproductive tract infections by secreting lactic acid to maintain a weakly acidic vaginal environment, producing hydrogen peroxide, competing for nutrients (such as glycogen), occupying binding sites on vaginal epithelial cells, and stimulating local vaginal immunity.

Given the critical role of Lactobacillus crispatus in maintaining vaginal health, Suzhou Ousai Microtech has screened a dominant strain, designated Lc262-1, from vaginal Lactobacillus crispatus isolated from healthy Chinese women. Leveraging its independently owned intellectual property “Natural Microecological Drug R&D Platform,” the company has developed live bacterial capsules with high pharmaceutical stability.

About Bacterial Vaginosis

Bacterial Vaginosis (BV) is one of the common vaginal infectious diseases among women of childbearing age. It is a vaginal infection characterized by a reduction or disappearance of normal Lactobacillus in the vagina, accompanied by an increase in facultative anaerobic and anaerobic bacteria. In China, there are over 70 million clinical outpatient visits for BV annually.

Bacterial vaginosis (BV) has an extremely high recurrence rate. The recurrence rate is approximately 20% at one month post-treatment, can reach 40% at three months, and may be as high as 60% at twelve months. Furthermore, BV can lead to pelvic inflammatory disease, post-gynecological surgical infections, and infertility. BV during pregnancy is associated with adverse pregnancy outcomes, including miscarriage, preterm birth, premature rupture of membranes, chorioamnionitis, neonatal infection, and puerperal infection. BV also increases the risk of infection with sexually transmitted pathogens, such as human papillomavirus (HPV), human immunodeficiency virus (HIV), Neisseria gonorrhoeae, Chlamydia trachomatis, and herpes simplex virus type 2 (HSV-2).

About Suzhou Ousei Micro Biopharmaceutical Technology Co., Ltd.

Suzhou Ousai Weike Biopharmaceutical Technology Co., Ltd., established in 2011, is a biopharmaceutical enterprise dedicated to the research and development of live biotherapeutic products. Since its inception, the company has progressively built its proprietary “Natural Microbiome Drug R&D Platform.” Its core patents cover mainland China and Taiwan, and have been extended to the United States, the European Union, Japan, South Korea, Southeast Asia, and other regions through the Patent Cooperation Treaty (PCT) system.

With the mission of “Respecting Life, Caring for Health,” Ousai Weike is dedicated to the development of human microbiome-based therapeutics. The company’s first novel drug, Live Lactobacillus crispatus Capsules, has completed Phase III clinical trials, demonstrating a significant trend in reducing the recurrence of bacterial vaginosis (BV) and showing great potential in the treatment and prevention of gynecological infections associated with dysbiosis. Moving forward, the company will submit a marketing application for Live Lactobacillus crispatus Vaginal Capsules to the National Medical Products Administration in accordance with national drug registration regulations.