CTV-05

SUZHOU, China--(BUSINESS WIRE)-- Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints. 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.

New findings suggest that a probiotic combination could reduce incidence of toxic shock syndrome. The widespread, pathogenic microbe Staphylococcus aureus can colonize the skin and mucous membranes throughout the body, particularly the vagina and gastrointestinal tract. A virulent strain of the bacterium produces proteins that trigger toxic shock syndrome (TSS), a disease characterized by the quick onset of fever, a telltale rash, and, without treatment, multi organ failure. In the vagina, TSS is associated with a life-threatening reaction from the immune system. Probiotics may help prevent the disease before the cytokine cascade ever begins. A study published in the American Society for Microbiology's journal Microbiology Spectrum reports that strains of 2 bacteria, Lactobacillus acidophilus and Lacticaseibacillus rhamnosus, successfully inhibited the production of the superantigens that cause TSS, in lab experiments. L. acidophilus, in addition, inhibited the growth of the S. aureus strains that produce the problematic proteins. A combination of the 2 could both prevent growth and inhibit the immune response. "It's kind of a double whammy against S. aureus," said microbiologist Patrick Schlievert, Ph.D., at the University of Iowa Carver College of Medicine, in Iowa City. "If any toxin is made, the probiotics still prevent inflammation." He noted that adding these probiotics to tampons or other menstrual products could reduce the risk -- and global incidence -- of TSS associated with menstruation. Such a preventive measure has the potential to benefit millions of vulnerable people, Schlievert said. "We know that 20% of people over age 12 cannot make antibodies and never will make antibodies against toxic shock syndrome," he said. Schlievert has been studying TSS -- and its prevention -- for decades. In the early 1980s, he was the first researcher to identify the toxin that triggers an overreaction of the immune system, and to show how high-absorbency tampons facilitated production of that toxin if S. aureus was present. The new work, he said, was motivated by observations made during an earlier study. A few years ago, he and his colleagues recruited 205 women to test whether a novel molecular mixture, when added to tampons, would inhibit pathogenic bacteria. That molecule proved effective against E. coli and other pathogens, but the researchers noticed an unexpected consequence. "Some of the women in the treatment group had this tremendous growth of Lactobacilli," Schlievert said. Further studies revealed that 9 of those women were colonized with only L. crispatus and no other bacteria. In microbiology research, Schlievert said, colonization by a single bacterium is often regarded as unhealthy. In this case, however, it offered an effective action against pathogenic S. aureus. Lactobacillus bacteria have already been shown to be safe, Schlievert said, and the new work suggests that treatment with L. crispatus alone, or L. acidophilus and L. rhamnosus in combination, could dramatically reduce the risk of TSS in vulnerable populations. Strains of S. aureus can also cause enterocolitis, a life-threatening immune response in the gut. Probiotics may also help reduce the production of dangerous proteins for that disease, said Schlievert. In ongoing and future work, Schlievert and his team are investigating how to use probiotics to prevent skin staph infections. The skin of people with atopic dermatitis, or with type 2 diabetes, is often colonized with the strains of S. aureus that produce superantigens, which are often resistant to treatment with standard antibiotics. In patients with type 2 diabetes, those superantigens could lead to foot ulcers that, if not treated successfully, could lead to amputation. Schlievert sees probiotics as a promising way to prevent those complications. "If we can improve their lives by using this approach, that would be wonderful."