Karolinska Development’s portfolio company Dilafor initiates Phase 2b clinical trial with tafoxiparin in women planned for labor induction

STOCKHOLM – July 9, 2019. Karolinska Development’s portfolio company 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 Viktor Drvota, CEO of Karolinska Development.

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

TO THE EDITORS

About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that

advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.

Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.

Karolinska Development has established a portfolio of nine companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.

For more information, please visit www.karolinskadevelopment.com

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