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<\/a><\/a>\nLACTIN-V is a live biotherapeutic product (LBP) containing the beneficial bacterium Lactobacillus crispatus<\/i>, which has been designed to restore a healthy vaginal microbiome. Imbalance in the vaginal microbiome is thought to be a major underrecognized risk factor for poor pregnancy outcomes, including preterm birth and late miscarriage.<\/p>
\nThe FLIP\u20112 trial will be led by Dr. Lynne Sykes (Chief Investigator), Professor Phillip Bennett (Principal Investigator), and Dr. Ryan Love (Associate PI) at the March of Dimes Prematurity Research Center (PRC) at Imperial College London.<\/p>
\n\u201cFor families facing the fear of preterm birth, the absence of effective treatments for microbiome imbalance in the reproductive tract is devastating. This trial represents a truly unique opportunity to test an intervention that targets a clearly defined cause of PTB, rather than a one\u2011size\u2011fits\u2011all solution,\u201d said <\/b><\/i>Dr. Sykes, Parasol Foundation Clinical Associate Professor in Obstetrics at Imperial College London.<\/i><\/b> \u201cIf successful, it could move us toward a far more personalised and precise approach to preventing preterm birth, giving women a better chance to deliver their babies safely at the right time.\u201d<\/i><\/p>
\n\u201cThis exciting trial represents a paradigm change in the prevention of PTB, targeting activation of host immune responses to the reproductive tract microbiome,\u201d said Professor Bennett, Professor of Obstetrics and Gynaecology and Acting Head of the Department of Metabolism, Digestion and Reproduction at Imperial College London.<\/b> \u201cIt is the first new treatment for preterm birth in decades, and unlike previous therapies, aims to prevent the activation of the mechanisms causing preterm labor, rather than trying to stop preterm labour once it has started.\u201d<\/i><\/p>
\nThe FLIP\u20112 study represents the most advanced clinical trial to date of a microbiome\u2011based therapy aimed at preventing PTB, marking a major step forward in women\u2019s health and microbiome science. It follows the encouraging results from the prior FLIP\u20111 Phase 1 study conducted at the March of Dimes PRC at Imperial College London by Professor Bennett, Dr. Sykes and Professor David MacIntyre. This open\u2011label pilot showed that LACTIN\u2011V is safe, well\u2011tolerated, and highly acceptable to pregnant women at high risk of preterm birth. Importantly, the study observed a lower rate of preterm birth compared with historical controls, providing strong rationale for advancing LACTIN\u2011V into this larger, placebo-controlled Phase 2b trial.\u00b9<\/p>
\n\u201cWe are excited to work with Imperial and March of Dimes on this groundbreaking clinical trial addressing a major unmet need in pregnancy,\u201d said Peter P. Lee, MD, Founder and Executive Chairman of Osel. <\/b>\u201cProfessor Bennett and Dr. Sykes are world-renowned experts on the impact of vaginal microbiome disruption and inflammation on the risk of PTB. We are honored to work with them to further explore the potential of LACTIN-V in this vulnerable population.\u201d<\/i><\/p>
\nThe double\u2011blind study evaluating LACTIN\u2011V against a matching placebo aims to enroll 360 pregnant patients at high risk of early birth across four maternity units in the United Kingdom. Imperial College London is sponsoring the study, with funding support from the March of Dimes and the NIHR Imperial Biomedical Research Centre, underscoring the strong international commitment to advancing new solutions for preterm birth.<\/p>
\n\u201cAfter nearly a decade supporting this incredible research team working to understand and mitigate microbiome-driven preterm birth, we are thrilled to be at the doorstep of the first randomized controlled trial of a live biotherapeutic to prevent early labor,\u201d said March of Dimes Chief Scientific Advisor Dr. Emre Seli.<\/b> \u201cNot only is this a historic trial, it\u2019s also a very promising one, with potential to dramatically reduce preterm birth rates in our lifetime.\u201d<\/i><\/p>
\nFor more information about the FLIP\u20112 study, visit: https:\/\/www.isrctn.com\/ISRCTN13610566<\/a><\/p> \nAbout LACTIN-V<\/b><\/p> \nLACTIN-V is a powder delivered vaginally utilizing a proprietary applicator. By delivering L. crispatus<\/i> directly to the vagina, LACTIN\u2011V supports stable colonization of this protective bacterium, \u2018flipping the flora\u2019, and helps reduce vaginal inflammation, addressing a key biological pathway linked to preterm birth.<\/p> \nWomen with high levels of L. crispatus<\/i> have a significantly lower risk of preterm birth, while those with low levels and high microbial diversity experience greater vaginal inflammation, placing them at increased risk of premature rupture of membranes (PPROM), early delivery, and low\u2011birthweight infants.<\/p> \nOsel holds an exclusive worldwide license with ICL for intellectual property covering the use of LACTIN-V, a live biotherapeutic product, in PTB.<\/p> \nAbout Preterm Birth (PTB)<\/b><\/p> \nPreterm birth (PTB) is the leading cause of death in children under five worldwide, claiming nearly one million lives every year. Survivors often face lifelong challenges, including disability and developmental delays, making PTB one of the most urgent global threats to child health and wellbeing.<\/p> \nThe economic impact is equally profound: PTB costs tens of billions of dollars annually in medical care, lost productivity, and long\u2011term support services, with expenses rising sharply for babies born before 28 weeks of gestation.<\/p> \nAgainst this backdrop, treatment options remain extremely limited. In April 2023, the FDA withdrew approval of Makena\u00ae (hydroxyprogesterone caproate) after post\u2011market studies failed to confirm its effectiveness in preventing preterm birth. As a result, there are no FDA\u2011approved therapies available to prevent PTB.<\/p> \nAbout Osel Inc.<\/b><\/p> \nOsel Inc., headquartered in Mountain View, California, is a privately held biopharmaceutical company dedicated to developing and commercializing live biotherapeutic products aimed at preventing or treating major medical conditions by modulating the human microbiome. As a pioneer in the field of LBPs, Osel focuses primarily on oncology and women\u2019s health. For more information, visit oselinc.com<\/a>.<\/p> \nAbout Imperial College London<\/b><\/p> \nWe are Imperial \u2013 a world-leading university for science, technology, engineering, medicine and business (STEMB), where scientific imagination leads to world-changing impact.<\/p> \nAs a global top ten university in London, we use science to try to understand more of the universe and improve the lives of more people in it. Across our 10 campuses and throughout our Imperial Global network, our 22,000 students, 8,000 staff, and partners work together on scientific discovery, innovation and entrepreneurship. Their work navigates some of the world\u2019s toughest challenges in global health, climate change, AI, business leadership and more.<\/p> \nFounded in 1907, Imperial\u2019s future builds on a distinguished past, having pioneered penicillin, holography and fibre optics. Today, Imperial combines exceptional teaching, world-class facilities and a habit of interdisciplinary practice to unlock scientific imagination.<\/p> \nAbout March of Dimes<\/b><\/p> \nMarch of Dimes leads the fight for the health of all moms and babies. We support research, education, and advocacy, and provide programs and services so that every family can have the best possible start. Since 1938, we\u2019ve built a successful legacy to support every pregnant person and every family. Visit marchofdimes.org<\/a> or nacersano.org<\/a> for more information. Find us on Facebook and follow us with #marchofdimes and @marchofdimes.<\/p> \nReferences:\n \nMedia Contacts:<\/b><\/p> \nColin Sanford for Osel Inc.\n \nOlesia Plokhii for March of Dimes\n