Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities

STOCKHOLM, SWEDEN 30 January 2025. Dilafor has successfully completed regulatory meetings with the U.S. Food and Drug Administration, FDA, and European Health Agencies, regarding the continued development of the company’s drug candidate tafoxiparin. The completed meetings mark the end of a comprehensive dialogue with regulatory authorities in the US and EU to reach an alignment between the authorities on designing pivotal clinical Phase 3 studies in Europe and the US to evaluate tafoxiparin as a new potential treatment for priming of labor. Dilafor has completed interactions with US and European authorities during 2023 – 2024 to achieve an alignment in the regulatory process ahead of the upcoming clinical phase 3 trials with the company’s drug candidate tafoxiparin, developed for priming of labor. Positive outcomes from scientific advice meetings with the FDA and the EMA, were followed by a Simultaneous National Scientific Advice, SNSA, including five key national EU authorities, in December 2024. The meetings resulted in an agreement on the overall study design; in particular the primary endpoint, inclusion criteria, and the performance of the study. Following this positive development, Dilafor will now finalize the detailed planning for pivotal Phase 3 studies in the US and Europe. “There is generally a lack of new product development in the obstetrical area, and tafoxiparin represents a new principle and mode of action compared to available therapies. The extensive interactions with regulatory bodies in the US and Europe have been extremely helpful and have led to an alignment on the design of a Phase 3 program. Along the way, the FDA has been clear that they share the view on tafoxiparin’s mode of action resulting in priming of labor,” says Lena Degling Wikingsson, CEO, Dilafor. Currently, more than 30 percent of term pregnant women are induced into labor. Existing interventions require fetal and maternal surveillance in hospital due to maternal and fetal high risk of complications, generating high healthcare costs. National guidance for labor induction have recently been revised to encourage delivery at 39 weeks of gestation in the US and at 40–41 weeks in Europe. The change in routines is supported by strong scientific publications and has been shown to reduce the risk of stillbirth, neonatal complications, operative deliveries leading to improved maternal and neonatal outcomes. The new guidance will lead to a further increase in the number of deliveries requiring labor induction. To reduce the constraints at the obstetrical clinics a new, safe home-based treatment option for labor priming may be a future solution. Tafoxiparins novel mechanism of action represents a potential breakthrough in obstetrical care by mimicking the natural priming of labor process. The drug candidate uniquely initiates both cervical ripening and myometrial remodeling over several days, initiating a spontaneous onset of labor leading to a vaginal delivery without traditional mechanical or pharmacological interventions. Tafoxiparin is the first drug developed for self-administration by the mother using a daily autoinjector at home, marking a possible improvement in quality of life for the pregnant woman and her family. Moreover, the tafoxiparin drug candidate has in Phase II studies demonstrated potential to reduce fetal and maternal complications and associated healthcare expenses. “Randomised studies from Europe and US have shown that earlier start of labor is related to a significant reduction in infant mortality and maternal complications. The available drugs are recommended to be given under fetal and maternal surveillance to avoid complications. The increase of labor inductions is putting pressure on an already strained maternity care system. There have been no drugs developed in the obstetrical area for more than 40 years. Tafoxiparin is the first drug candidate developed for treatment at home by priming of labor mimicking the natural process and resulting in a spontaneous onset of labor.” says Gunvor Ekman Ordeberg, CMO and founder, 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 obstetrical indications. 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

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