Karolinska Development portfolio company Dilafor initiates Phase IIb clinical trial with tafoxiparin in women with protracted labor

Solna, SWEDEN


Karolinska Development AB (Nasdaq Stockholm:KDEV) today announces that its 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 IIb study with tafoxiparin in pregnant women who experience slow progress of labor or labor arrest after spontaneous onset.

Details from the Dilafor press release follow:

Tafoxiparin is in clinical development as a new treatment designed to decrease the incidence of protracted labor (i.e labor that lasts more than 12 hours), which is the main cause of emergency surgical deliveries such as caesarian section. The condition is often associated with complications for both mother and child. Tafoxiparin has shown in a Phase II clinical trial encouraging evidence that it can decrease the proportion of women with labor more than 12 hours.

The Phase IIb study is a multi-center, double blind, placebo-controlled dose-finding study in term-pregnant first-time mothers that after spontaneous onset of labor require labor augmentation due to primary slow progress or labor arrest. The pregnant women will be randomized to receive one of three different dosages of tafoxiparin or placebo. The treatment will be as an adjunct to standard of care, which is intravenous infusion of oxytocin. The target is to enroll 360 pregnant women in the Phase IIb study.

This proof of concept study is designed to demonstrate reduced time to vaginal delivery defined as time from start of tafoxiparin treatment until delivery. Secondary endpoints include safety, proportion of women with labor time more than 12 hours, number of women with instrumental deliveries such as vacuum extraction and number of caesarian sections. The study is planned to be performed in two countries in Europe including up to 14 delivery clinics. Sweden is the first country to be included.

Lena Degling Wikingsson, CEO of Dilafor, said: “We are excited to initiate this proof of concept study with tafoxiparin in this important indication. The only option for pregnant women who experience protracted labor and do not respond to current clinical practice is acute caesarian sections, which are often associated with complications for both mother and child. We have already seen encouraging results in a completed clinical study with tafoxiparin and look forward to the results of this new trial, which if positive, will pave the way for a pivotal trial and potentially a new treatment option for patients.”

Viktor Drvota, Chief Investment Officer of Karolinska Development, adds: “Dilafor’s progress over the last 12 months has been really positive. The Company recently completed a financing round to support it through to its next value inflection point; and having recently been granted a U.S. patent for tafoxiparin, the start of Dilafor’s Phase IIb study is yet another important development for the Company.”

For further information, please contact:

Jim Van heusden, CEO, Karolinska Development AB
Phone: +46 72 858 32 09, e-mail: jim.van.heusden@karolinskadevelopment.com

Christian Tange, CFO, Karolinska Development AB
Phone: +46 73 712 14 30, e-mail: christian.tange@karolinskadevelopment.com

David Dible/Mark Swallow/Pip Batty, Citigate Dewe Rogerson
Phone: +44 20 7638 9571; e-mail: KDev@citigatedr.co.uk

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 heparan sulphate mimetic, a proprietary polysaccharide based drug developed by Dilafor. Women that experience protracted and complicated labor have deficiency in heparan sulphate which is a naturally occurring polysaccharide and plays an important role in labor. Preclinical and clinical data show that tafoxiparin fulfills the role of heparan sulphate and works in conjunction with naturally occurring molecules important in child birth. Slow progress of labor has an incidence of approximately 40% of all pregnant women. It is associated with a number of both long and short term maternal and fetal complications such as emergency caesarean sections, postpartum hemorrhages, vaginal tears, anal ruptures, meconium-stained amniotic fluid and asphyxia. These complications lead to short and long term consequences for the mother and the newborn in addition to substantial health care costs.

About Karolinska Development AB

Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying medical innovation and investing in the creation and growth of companies developing these assets into differentiated products that will make a difference to patients’ lives and provide an attractive return on investment to its shareholders.

Karolinska Development has access to world-class medical innovations at leading universities and research institutes in the Nordic region, including the Karolinska Institutet. The Company aims to build companies around innovative products and technologies, supported by experienced management teams and advisers, and co-funded by specialist international life science investors, to provide the greatest chance of success.

Karolinska Development’s portfolio comprises 10 companies focusing on the development of innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by a team of investment professionals with strong investment backgrounds, experienced company builders and entrepreneurs, with access to a strong global network. For more information, please visit www.karolinskadevelopment.com