Clinical studies 

Dilafor successfully completed a phase IIb clinical study on the indication Priming of labor. Reported in February 2023. The study was a multi-center, double blind, placebo-controlled proof of concept and dose finding study in term-pregnant first-time mothers with an unripe cervix that are planned for start of labor. The pregnant women were randomized to either subcutaneous injection of tafoxiparin or placebo once daily up to one week prior to scheduled labor onset of labor.

The study enrolled 349 women, in the four treatment groups.
The results showed 59% of the tafoxiparin treated women to go into spontaneous onset of labor or reached a ripe cervix only with tafoxiparin treatment, compared to 39% in placebo. Moreover, the women treated with tafoxiparin had significantly fewer instrumental deliveries and also fewer neonates been diagnosed with fetal distress. Furthermore, the effect of tafoxiparin treatment resulted in a high number of uneventful vaginal deliveries without conventional treatments compared to placebo.
Tafoxiparin was safe and well tolerated by the women and neonates and 88% of the women received epidural during labor. There were no hypercontractility associated with tafoxiparin treatment. The full results from the study will be published in a scientific journal and at medical congresses.

For further information on the study and participating clinical sites, please see:

https://clinicaltrials.gov/ct2/show/NCT04000438?term=PPL17&draw=2&rank=1

In 2018, a randomized phase IIB, double-blind, placebo-controlled, parallel-group, dose-finding study comprising a total of 370 women was completed. The study evaluated the effects of continuous infusion of tafoxiparin as an adjunct treatment to oxytocin for up to 36 hours in term pregnant, nulliparous women in order to treat primary slow progress of labor including prolonged latent phase and primary labor arrest. Tafoxiparin was shown to be safe and well tolerated amongst both women and children, but no statistically significant efficacy was observed in any of the dose levels studied. The data received indicate that the use of tafoxiparin as an emergency treatment may not be feasible and that a longer exposure period of tafoxiparin may be necessary to reach the efficacy achieved in previous in clinical trial. The full results from the study is published in the scientific journal American Journal of Obstetrics and Gynecology, 2023.

For further information on the study, please see:

https://clinicaltrials.gov/ct2/show/NCT03001193?term=PPL07&rank=1

In 2009, an exploratory Proof of Concept phase II clinical study, comprising a total of 263 women, was completed. Tafoxiparin was shown to be safe and well tolerated, and analyses of the results indicate that treatment with tafoxiparin can provide beneficial effects in term pregnant women with unripe cervix and with planned start of labor and in women with need of oxytocin. Most importantly, the results of the study gave Dilafor a solid base with which to plan in detail the further and ongoing clinical development program for a number of indications within the obstetric field. The full result from the study is published in the scientific journal American Journal of Obstetrics and Gynecology, 2023.

For further information on the study, please see: 

https://clinicaltrials.gov/ct2/show/NCT00710242?term=PPL02&rank=1

In 2015 and 2016, Dilafor performed and finalized additional phase I studies in Europe and Asia. The phase I studies were focused on the evaluation of the safety and pharmacokinetics of tafoxiparin using a multidosing schedule of tafoxiparin. The study demonstrated tafoxiparin to be safe and well tolerated and with a predictive pharmacokinetic profile. The outcomes of the studies were used in the planning of the global clinical trial program in two major indications: Priming of labor and labor arrest.