drugset / Press release

Dilafor presents top line result from a Phase IIb study in tafoxiparin

2018-11-01 · Dilafor AB · original dilafor.com ↗

STOCKHOLM, SWEDEN– November 1, 2018. Dilafor AB, announces today top line results from a Phase IIb study in tafoxiparin. The primary endpoint of the study - reducing time to vaginal delivery, defined as time from start of tafoxiparin treatment until delivery - was not met. Dilafor today presents results from a Phase IIb‑study in tafoxiparin ‑ a drug candidate that targets the problem of protracted labor in a completely new way compared to treatments available today. In the study, 360 women were randomly divided into one of four treatment arms, either in one of three treatment arms with different doses of tafoxiparin or in a placebo arm. In the active dose groups the women were administered a low, medium or high dose of tafoxiparin in combination with the standard treatment for protracted labor – oxytocin. Tafoxiparin was well tolerated amongst both women and children, but no statistically significant efficacy was observed in any of the dose levels studied. A full review of the drug candidate’s safety profile will be presented as soon as all patients have completed a follow‑up period. “The area of protracted labor has for a long time been overlooked – the standard treatment, oxytocin, was introduced already in the 50’s. Even with this setback in the development of tafoxiparin it is important that we continue to work towards reducing the labor‑related complications that arise in connection with protracted labor”, says Gunvor Ekman Ordeberg, CMO and co-founder of Dilafor. The full results from the study will be published in a scientific journal or at a medical congress at a later stage. For further information, please contact: Lena Degling Wikingsson, CEO at Dilafor AB Phone: +46 (0)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 The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest. 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 child birth. 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. Dilafor FINAL Top line data ENG Dilafor FINAL Top line data SWE

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