The Phase III study was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 320 patients with bacterial vaginosis (BV). After receiving seven days of oral metronidazole and vaginal LBP/placebo combination therapy, the cured patients were followed up for three months.
The results from the treatment group were superior to the placebo group on the primary and secondary endpoints, with statistically significant differences between the two groups. In terms of safety, there was no difference in the incidence of adverse events or adverse reactions between the two groups.
“The prevention of recurrent infection is critical in treating gynecological infections,” said Prof. Liu Zhaohui, MD, the principal investigator of the study and vice-chair of the Infection Working Group of the Chinese Medical Association's Department of Obstetrics and Gynecology, Capital Medical University Affiliated Beijing Obstetrics and Gynecology Hospital. “In China, more than 70 million BV cases are reported annually, with a 12-month recurrence rate of up to 60%. Currently, there are very limited effective treatments available. The positive results of this Phase III clinical trial have demonstrated the efficacy of L. crispatus in suppressing BV recurrence, providing patients with a new treatment option.”
“Vaginal L. crispatus live bacteria capsule is a novel Live Biotherapeutic Product (LBP) that aims to restore healthy vaginal microbiota by using L. crispatus to prevent and reduce the recurrence of vaginal infections,” said Dr. Liu Yang, co-founder and chief scientific officer of Suzhou OSAI Biopharma. “This Phase III clinical trial is the first registrational Phase III clinical trial globally to evaluate the efficacy of L. crispatus in reducing BV recurrence under a rigorous clinical design. The observed data is encouraging, our team is committed to continuing to advance the program in regulatory registration and further expand our LBP pipeline.”
About Vaginal L. crispatus Live Bacteria Capsule
Vaginal L. crispatus live bacteria capsule is a first-in-class, innovative LBP developed by Suzhou OSAI Biopharma, utilizing live L. crispatus bacteria to restore the balance of the vaginal microbiome.
L. crispatus is the most common and dominant bacteria in the vaginas of healthy Chinese women of childbearing age. The presence and enrichment of L. crispatus in the vaginal environment is considered a marker of healthy vaginal microbiota. L. crispatus can suppress the growth of other microorganisms through various mechanisms, such as maintaining a weakly acidic environment in the vagina by producing lactic acid, producing hydrogen peroxide, competing for nutrients (such as glycogen), occupying space (by competing for adhesion to vaginal epithelial cells) and stimulating local vaginal immunity.
In recognition of the important role of L. crispatus in maintaining vaginal health, Suzhou OSAI Biopharma selected a strain of L. crispatus, Lc262-1, from the vaginal microbiota of healthy Chinese women. Leveraging its proprietary “Natural Microbiome Drug Development Platform,” the company developed a highly stable live bacteria capsule.
About Bacterial Vaginosis
Bacterial vaginosis (BV) is a common vaginal infection in women of childbearing age. It is caused by an overgrowth of anaerobic bacteria in the vagina. In China, there are over 70 million cases of BV each year.
The recurrence rate of BV is high, roughly 20% within one month of treatment, 40% within three months of treatment, and 60% within 12 months of treatment. BV can also lead to pelvic inflammatory disease, post-surgical infections after gynecological surgery, and infertility. BV in pregnancy can lead to miscarriage, preterm birth, premature rupture of membranes, chorioamnionitis, neonatal infection, and postpartum infection. BV can also increase the risk of sexually transmitted infections (STIs), such as those caused by HPV, HIV, Neisseria gonorrhoeae, Chlamydia trachomatis, and herpes simplex virus type 2.
About Suzhou OSAI Biopharma
Founded in 2011, Suzhou OSAI Biopharma is a biopharmaceutical company focused on the research and development of LBPs. The company has built its own proprietary "Natural Microbiome Drug Development Platform" since its inception, with patents covering the Greater China Area, United States, Europe, Japan, South Korea, and Southeast Asia.
OSAI Biopharma is committed to the research and development of LBPs to restore the healthy balance of human microbiome. Its lead asset, live L. crispatus capsule, has completed a Phase III clinical trial and demonstrated significant potential in the treatment and prevention of BV related to microbiota dysbiosis.
OSAI Biopharma anticipates applying for Biologics License Applications (BLA) of its vaginal L. crispatus capsule to the China NMPA’s Center of Drug Evaluation (CDE) in the near future.
