Dilafor announces last subject enrolled in Phase 2b clinical trial with tafoxiparin in women planned for labor induction

STOCKHOLM – April 6, 2021. Dilafor AB, a women’s health company focusing on the development of tafoxiparin for obstetric indications, has enrolled the last subject in its Phase 2b study with tafoxiparin in pregnant women planned for labor induction. 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 have been randomized to either subcutaneous injection of tafoxiparin or placebo once daily up to one week prior to scheduled labor induction. The treatment was then followed by induction according to clinical practice, which is usually balloon catheter or hormonal treatment. The target of 170 patients has been reached, enrollment have been done at clinics in Sweden and Finland. Dilafor has enrolled the last 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. “We are very pleased to have accomplished this clinical milestone in a time when the pandemic is affecting all of us and especially the health care system. We would like to thank the patients, their families, and the clinical sites who are participating in the study.” says Lena Degling Wikingsson CEO of Dilafor 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. “Full enrollment in the middle of a pandemic reflects the strength of the unmet need within the obstetric field, and tafoxiparin has the potential to become a completely new treatment option for pregnant women that have high risk of fetal and maternal complications. We look forward to having top-line data on safety and efficacy late Q2 this year” says professor Gunvor Ekman Ordeberg, Chief Medical Officer and founder of Dilafor. For further information, please contact : Lena Degling Wikingsson, CEO, Dilafor AB Phone: +46 70 790 02 07 TO THE EDITORS About Dilafor AB Dilafor AB is a Swedish drug development company focusing on the development of tafoxiparin for obstetric indications. The company’s primary goal is to decrease the incidence of slow progress of labor both after induction of labor and after spontaneous onset of labor. The main owner of Dilafor is KDev Investments AB, which is jointly owned by Karolinska Development AB (publ) and Rosetta Capital IV. The other main owners are Opocrin S.P.A and the Foundation for Baltic and European Studies (Östersjöstiftelsen). For more information, please visit: www.dilafor.com . About tafoxiparin Tafoxiparin is a proprietary polysaccharide based drug developed by Dilafor. Women that experience protracted and complicated labor have deficiency in a naturally occurring submucosal molecule that plays an important role in labor. Preclinical and clinical data show that tafoxiparin fulfills the role of this molecule and works in conjunction with naturally occurring molecules important in childbirth. Slow progress of labor has an incidence of approximately 40 per cent of all pregnant women and can cause complications both during and after the labor for both the mother and child. Examples of maternal complications are emergency caesarean sections, postpartum hemorrhages, vaginal tears, anal ruptures and an increased risk of infection in the uterus after the labor. Slow progress of labor creates a tension on the fetus and can cause lower oxygenation of the fetus but also an increased risk of an infection in the child. These complications lead to short- and long-term consequences for the mother and the newborn in addition to substantial health care costs. Last patient enrolled PPL17 2021 04 06

The release as fetched from its publisher. dilafor.com ↗