Postoperative infection

-Top-line data including safety, tolerability, and biomarker activity anticipated this summer- -This Phase 1 clinical study data will support further development across multiple indications- SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has commenced a first in human Phase 1 clinical study (RVL-HV02) to evaluate escalating doses of intravenously administered Gemini. The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age. Top-line data including safety, tolerability, and biomarkers of target activity are expected this summer. Data from this Phase 1 clinical study will support future development across multiple indications. Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with PHAD potentially preconditions the innate immune system to respond to a subsequent stress, such as ischemia (loss of blood flow) or bacterial infection. Gemini is initially being developed for two target indications: as a pretreatment to prevent or reduce the severity of acute kidney injury (AKI) due to cardiac surgery and as a pretreatment to reduce the incidence, duration, and severity of post-surgical infection. Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI. Additionally, preclinical studies using models of bacterial infection have demonstrated pretreatment with PHAD can reduce the overall rate and severity of infection. “AKI is a significant and increasingly frequent health problem, especially in patients with co-morbidities such as diabetes. There are no approved therapies for preventing AKI.” said James Rolke, Chief Executive Officer of Revelation. “In addition, post-surgical infections and the continuous emergence of global antibiotic resistance necessitates the need for new therapies including those that can prevent infection. The start of this study is an important step toward bringing a potential new therapy for these unmet needs.” About Gemini Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program), as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications. About Revelation Biosciences Inc. Revelation Biosciences, Inc. is a life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including GEMINI-SSI as a prevention for post-surgical infection, GEMINI-AKI as a prevention for acute kidney injury, and GEMINI-CKD for the treatment of chronic kidney disease. For more information on Revelation, please visit . Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

A large multicenter clinical trial found that an antiseptic containing iodine resulted in about one-quarter fewer post-surgical infections in patients with limb fractures compared to another frequently used skin antiseptic. Researchers believe the results of the study of nearly 8,500 patients across the United States and Canada could prevent thousands of surgical-site infections each year. A large multicenter clinical trial co-led by University of Maryland School of Medicine researchers large multicenter clinical trial co-led by University of Maryland School of Medicine researchers found that an antiseptic containing iodine resulted in about one-quarter fewer post-surgical infections in patients with limb fractures compared to another frequently used skin antiseptic. The results of the study of nearly 8,500 patients across the United States and Canada were published today in the New England Journal of Medicine. The study -- which compared the two most commonly used alcohol-based solutions, one with iodine povacrylex, and the other with chlorhexidine gluconate -- may prompt changes in the type of antiseptic orthopaedic surgeons use to prepare the skin to repair fractures. Researchers saw the benefit in patients with closed, or simple fractures, where the skin remains intact, but not in compound fractures with open wounds, although they noted that using the iodine preparation was not harmful to these open-fracture patients. "Our results suggest that the use of iodine povacrylex in alcohol as a preoperative skin antiseptic could prevent surgical-site infections in thousands of patients with closed fractures each year," said co-principal investigator Gerard Slobogean, MD, MPH, an Associate Professor of Orthopaedics and Director of Clinical Research in the Department of Orthopaedics at the University of Maryland School of Medicine (UMSOM). He is also an orthopaedic trauma surgeon at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center (UMMC). Each year, more than a million Americans suffer a broken bone in the arm, leg, or pelvis that requires surgery, and about 3 percent of these patients develop a surgical-site infection. The source of bacteria could be the patient's skin, the injury environment, or from the hospital. Although some guidelines have favored using chlorhexidine gluconate over other iodine products, there has not been a consensus on the most effective agent. Dr. Slobogean and his colleagues believe that the trial, which included 8,485 patients treated at 25 trauma centers, is the largest randomized clinical trial ever conducted to compare the two antiseptics, which allowed them to detect important differences in infection. They said that the findings may also be relevant to other surgical specialties. More than 6,700 patients who had surgery to treat a closed lower extremity or pelvic fracture and 1,700 patients who had surgery to treat an open fracture participated in the study. The R Adams Cowley Shock Trauma Center and University of Maryland Capital Region Health's (UM Capital) trauma center in Largo, Md., were among more than two dozen trauma centers to enroll patients. UMMC and UM Capital are part of the 11-hospital University of Maryland Medical System (UMMS). "The results of this well-designed study provide some long overdue clarity to orthopaedic trauma surgeons with respect to which commonly used antiseptic skin preparation is more effective when preparing for fracture surgery," said study co-author Todd Jaeblon, DO, an Associate Professor of Orthopaedics at UMSOM who treats patients at UM Capital. Of the 3,205 closed-fracture patients who received 0.7% iodine povacrylex in 74% isopropyl alcohol, 77, or 2.4 percent, developed a surgical-site infection. That compares with 108, or 3.3 percent of the 3,272 patients who received 2% chlorhexidine gluconate in 70% isopropyl alcohol. In patients with open fractures, the number of patients who developed infections was similar between the two antiseptics -- 54 patients, or 6.5 percent of 825 patients in the iodine group, and 60 patients, or 7.3% of the 826 patients in the chlorhexidine group. "Extremity fractures and the challenging surgical-site infections that result from them pose a significant health care burden on our nation," said Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean, UMSOM, and Vice President for Medical Affairs, University of Maryland, Baltimore. "This pragmatic trial tested two widely used antiseptics, and its crossover design minimized selection bias. It also enrolled patients from 25 diverse hospitals in the U.S. and Canada, which improved the generalizability of the results; the strength of the study design could serve as a model for other researchers." The PREPARE (Pragmatic Randomized Trial Evaluating Preoperative Alcohol Skin Solutions in Fractured Extremities) trial was jointly led by UMSOM and McMaster University of Hamilton, Ontario. It was funded with $11.2 million from the Patient-Centered Outcomes Research Institute (PCORI), with additional support from the Canadian Institutes of Health Research. "This trial represents a highly successful collaboration between McMaster University, the University of Maryland School of Medicine, and 25 trauma centers across Canada and the United States," said co-principal investigator Sheila Sprague, PhD, an Associate Professor and Research Director at McMaster University. "This multidisciplinary approach allowed us to quickly and efficiently address an important clinical research question that will lead to the prevention of thousands of infections each year. Importantly, our collaborations will continue to grow to address other unanswered questions in orthopaedic trauma surgery." This is the second clinical study co-led by Dr. Slobogean and Dr. Sprague aimed at closing the gaps in the medical literature on the most effective infection-control techniques in orthopaedic surgery. In October 2022, they published the results of the Aqueous-PREP trial in The Lancet. They concluded that the choice of an aqueous antiseptic solution -- either 10% povidone-iodine or 4% chlorhexidine gluconate -- does not alter the risk of surgical-site infection for patients with an open fracture. Both Aqueous-PREP and PREPARE follow a master protocol called PREP-IT (Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma) to test infection prevention techniques in trials that will provide crucial evidence to help guide surgical practices. This research was supported by the PREP-IT investigators, which includes a network of over 200 physicians, allied health care professionals, trauma patients, and clinical researchers.

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.