FLIP-1 results showed Lactin-V was safe, well-tolerated, and reduced preterm birth rates compared to historical controls. Credit: Peakstock / Shutterstock.com.

Osel, Imperial College London’s clinical trials unit and March of Dimes have launched the Phase IIb FLIP-2 trial, assessing the efficacy and safety of Lactin-V, a microbiome-based therapy, in pregnant women at high risk of preterm birth (PTB).

Lactin-V is a live biotherapeutic product (LBP) that contains the bacterium Lactobacillus crispatus and aims to restore balance to the vaginal microbiome.

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Dr Lynne Sykes (chief investigator), Professor Phillip Bennett (principal investigator), and Dr Ryan Love (associate principal investigator) are leading the FLIP-2 study at the March of Dimes Prematurity Research Center (PRC), Imperial College London.

The trial builds on findings from the FLIP-1 Phase I study, which was conducted at the same centre.

Results from FLIP-1 indicated that Lactin-V was safe, well-tolerated, and acceptable to pregnant women at elevated risk of PTB, with the study showing a lower rate of preterm birth than historical controls.

Osel founder and executive chairman Peter Lee said: “We are excited to work with Imperial and March of Dimes on this groundbreaking clinical trial addressing a major unmet need in pregnancy.

“Professor Bennett and Dr Sykes are world-renowned experts on the impact of vaginal microbiome disruption and inflammation on the risk of PTB. We are honoured to work with them to further explore the potential of Lactin-V in this vulnerable population.”

The trial will enrol 360 high-risk pregnant patients across four UK maternity units.

Imperial College London is the study sponsor, with financial support from the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre and the March of Dimes.

Lactin-V is administered as a powder using an applicator. By directly delivering L. crispatus to the vagina, the therapy aims to support stable colonisation, reduce vaginal inflammation, and target biological pathways linked to preterm birth.

Osel holds global exclusive rights with Imperial College London for Lactin-V intellectual property addressing PTB.