Dilafor initiates Phase 2b clinical trial with tafoxiparin in women planned for labor induction

STOCKHOLM, Sweden – July 9, 2019. Dilafor AB, a drug development company focusing on the development of tafoxiparin for obstetric indications, has enrolled the first subject in its Phase 2b study with tafoxiparin in pregnant women planned for labor induction. About a quarter of all pregnant women are subject to labor induction. More than half of these inductions fail, which leads to protracted labor that entail an increased risk of complications for both mother and child. In a previous phase 2a study, subcutaneous administration of Dilafor’s drug candidate tafoxiparin has shown a significant positive effect with a shortened time to delivery and an enhanced ripening of the cervix in patients induced into labor. Dilafor has now enrolled the first subject in a phase 2b study to investigate in a larger group whether treatment with subcutaneously administered tafoxiparin can soften the cervix and improve the outcome of labor induction, and thereby shortening the time to delivery. The Phase 2b study is a multi-center, double blind, placebo-controlled proof of concept study in term-pregnant first-time mothers with an unripe cervix that are planned for labor induction. The pregnant women will be randomized to either subcutaneous injection of tafoxiparin or placebo once daily up to one week prior to scheduled labor induction. The treatment is then followed by induction according to clinical practice, which is usually balloon catheter or hormonal treatment. The target is to enroll 170 pregnant women in the study that is planned to be performed at delivery clinics in two countries in Europe. Sweden is the first country to be included. “There is a huge unmet medical need within the obstetric field, and Dilafor’s tafoxiparin has the potential to become a completely new treatment option for pregnant women that have high risk of fetal and maternal complications. That the first patient now is enrolled in the Phase 2b study is an encouraging step in the development of tafoxiparin", comments Lena Degling Wikingsson, CEO of Dilafor AB. For further information, please contact: Lena Degling Wikingsson, CEO at Dilafor AB Phone: +46 (0)70 790 02 07

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