Medical need and indication

The clinical challenge and medical need

Initiation of labor is one of the most frequently performed obstetric procedures in the world to prevent adverse perinatal and maternal outcome, and the rate is increasing. Recent data from 2022, indicates that up to 43% of pregnant women in the US are induced into labor, with a caesarean section rate of 31%. In Europe, up to 33% of pregnant women are induced into labor. However, this procedure is not free of risks with available pharmacological drugs and methods. Operative vaginal or caesarean delivery due to myometrial hypercontractility resulting in fetal heart rate abnormalities are frequent. 

New national guidelines in the United States and Europe are forcing the need for new, safe, effective and approved medical treatments to initiate labor and decrease the maternal and fetal complications. The American College of Obstetricians and Gynecologists (ACOG) is currently advising obstetricians to start labor at gestational week 39. The same trend is true in Europe with national guidelines recommending moving towards a gestational week 40 to start labor.

Priming of labor - Indication and market segmentation 

The expression “Priming of labor” is based on the mechanism of action of the drug candidate tafoxiparin. Treatment with the new drug candidate is associated with a remodeling of both the uterine and the cervical Extra Cellular Matrix (ECM) resulting in facilitation of labor and ripening of the cervix. This priming effect of both the myometrium and the cervix results in a condition open up for spontaneous onset of labor after only tafoxiparin treatment. This double effect substantially reduces the need for conventional labor induction in hospital. Furthermore, tafoxiparin, due to a good safety profile is considered to be suitable for an outpatient setting since no fetal or maternal surveillance is needed. 

Tafoxiparin is the only drug candidate in development for labor priming and the need for this new drug candidate is high since the number of women planned for start of labor will increase due to new regulations , including more than 60% of all pregnant women but also due to epidemiological factors driving the need for priming of labor: i) advancing age of women giving birth and ii) increase of diseases such as obesity and iii) gestational diabetes and hypertension which may occur in conjunction with obesity. The use of artificial reproductive technologies and resulting higher frequencies of multiple gestations also contribute to a collection of maternal conditions which pose risk and reduce the likelihood of normal spontaneous labor and delivery. 

Preclinical studies have shown the drug candidate tafoxiparin does not pass the placenta and thereby will not reach the fetus.

In an era of increasing health care costs, prolonged hospitalizations resulting from conventional induction of labor, the drug candidate tafoxiparin will offer an opportunity to manage medical expenditures more wisely. Tafoxiparin with its unique mechanism of action would be “first in class” for priming of the cervix and uterus and may lead to a paradigm shift in obstetrician's’ standard of care. The drug candidate tafoxiparin is planned to be administered by an autoinjector and the documented safety profile of tafoxiparin suggests it suitable for home-based treatment. 

Up to 50 % of all term pregnant women are planned for start of labor with conventional treatments, which carries a high risk of complications for both mothers and infants.