Dilafor AB

The Challenge

Insufficient labor – where the mother requires stimulation with oxytocin, occurs in more than half of all births and to an even higher degree among first-time mothers. In its most severe form, protracted labor, it can last more than 12 hours. It is the main cause of emergency surgical deliveries i.e. vacuum extraction and caesarian section, both of which are often associated with complications for both mother and child.

Dilafor's Solution

Dilafor's drug candidate, tafoxiparin, is based on a modification of LMWH that essentially eliminates the anti-coagulative effect and thus the heightened risk of bleeding. Tafoxiparin has been tested in a Phase IIa trial with 263 first-time mothers.  The study showed that significantly fewer women were in labor for more than twelve hours compared to placebo. It also showed significantly shorter labor time in induced labor conditions with tafoxiparin compared with placebo.

Competitive advantage

Tafoxiparin has a dual mode of action as it enhances ripening of the cervix and also improves the uterine contractility.  It has the potential to provide an effective solution to the challenge of protracted labor. Since it lacks any clinically relevant anti-coagulative effect, it can be used together with standard pain management procedures such as epidural anesthesia.

Market

Existing pharmacological therapies that  improve uterine contractions are usually insufficient. Consequently, there is strong interest in better treatments, such as tafoxiparin, that both strengthen contractions and ripen the cervix. Labor induction is currently used in more than 20 % of all deliveries¹. This indication – labor induction - is therefore considered as an appropriate target population for market entry. The next indication is labor arrest. In this instance the pregnant woman has a spontaneous onset of labor which later on weakens and results in labor arrest.  These markets collectively cover about 25 % of all births at present, and further potential is provided by a strong preference to move to better therapies rather than continue with high numbers of both elective and emergency surgical deliveries, which are expensive and carry additional risks.

Status

• Phase I clinical showed high tolerability and safety
• Phase IIa trial with tafoxiparin in 263 women completed
  - Significantly fewer first-time mothers in labor for more than twelve hours compared to placebo
  - Significantly shorter labor time in labor induction cases and with no cases of protracted labor in the tafoxiparin treated group (See illustration to the right)
• Excellent safety and tolerability