Medical need and indications

The clinical challenge and medical need

Insufficient, slow progress of labor – during which the mother requires stimulation with oxytocin – occurs in approximately forty percent of all births and to an even higher degree among first-time mothers. In its most severe form, known as protracted labor, it can last more than 12 hours. Protracted labor is the main cause of emergency surgical deliveries, e.g. vacuum extraction and caesarian section, both of which are often associated with complications for both mother and child. Other maternal and fetal complications associated with protracted labor include severe fetal asphyxia (deficient supply of oxygen to the infant) and post partum hemorrhage (excessive blood loss), which is the leading cause of maternal mortality. Existing pharmacological therapies that improve uterine contractions, including oxytocin and prostaglandins, are usually insufficient, hence the need for an effective treatment.

Indications and market segmentation 

The hypothesis for the various treatment effects of tafoxiparin is based on current understanding of its mode of action. There are clear signals in non-clinical and clinical studies conducted to date by Dilafor that tafoxiparin acts as an adjuvant to oxytocin. It is therefore a drug candidate in all conditions or situations where oxytocin is in clinical use today. It is important to establish that a future tafoxiparin therapy will fit current clinical routines during labor.

A number of indications for tafoxiparin have been identified:

Labor induction: Approximately 22% of all pregnant women are in need of labor induction, i.e. they do not have a spontaneous onset of labor. The procedure using standard of care such as prostaglandins and oxytocin often - and in more than 50% of cases associated with failed induction - lead protracted labor and to emergency cesarean sections (CS) or other maternal and fetal complications.

Labor arrest and primary slow progress of labor following spontaneous onset: Approximately 35% of women with a spontaneous onset of labor develop an arrest of labor, i.e. a primary slow progress of labor or prolonged latent phase. This condition carries an enhanced risk of being followed by protracted labor, often leading to emergency cesarean section (CS) or other maternal and fetal complications.

Post partum hemorrhage (PPH): PPH is a life-threatening complication occurring after delivery. Twenty-five percent of maternal deaths in low-income countries are related to PPH and is the most common reason of maternal deaths in high income countries. The incidence rate in Western Europe has increased from 1.5% in 1999 to 4.1% a decade later. The main reason for PPH is atonic uterus, in which the myometrium is unable to establish effective contractions. PPH is associated with protracted labor.

Reduction of cesarean sections with conversion to vaginal deliveries:
Many nulliparous women who fear a painful birth, or women who have undergone a protracted and painful vaginal birth, opt for a CS. In addition, in clinical practice the principle of “once a CS, always a CS” is not seldom applied. These are major reasons why CSs have reached epidemic proportions (30 - 50% of births), despite the fact that the procedure entails subjecting the mother to a major abdominal surgical procedure. WHO has recommended that the share of CS not exceed 15% of all births. With an efficient tool available, promising the ability to significantly reduce labor time, and above all, eliminate dystocia/protracted labor altogether, it should be possible to reduce the CS rate.

As many as 40% of all pregnant women experience protracted labor, which carries a high risk of complications for both mothers and infants.