ReproNovo, a clinical-stage biopharmaceutical company committed to addressing critical gaps in male and female fertility as well as women’s health, today announced that the first participant has been dosed in the Company’s EU Phase 2 clinical trial of RPN-002, entitled Nolasiban Optimized Regimen Dosing for Inhibition of Uterine Contractility (NORDIC). Aiming to reduce uterine contractility and maintain uterine quiescence, RPN-002 has the potential to increase pregnancy and live birth rates following embryo transfer in Assisted Reproductive Technology (ART) programs.
NORDIC is a randomized, placebo-controlled, double-blind, parallel-group, multicenter trial evaluating two dosing regimens of RPN-002 on uterine contractility and endocrine parameters (EU CT Number: 2025-524896-22). The study will investigate higher doses and a longer administration schedule than previously explored in this patient population, which we believe may increase the likelihood of success in this program. Enrollment is planned to include 120 randomized participants across five sites in Europe.
NORDIC is designed to generate the pharmacodynamic evidence needed to guide selection of an optimized dosing regimen for future clinical evaluation in improving implantation rates in IVF and ICSI,
By assessing uterine contractility and other factors relevant for embryo implantation, the study will help us build on our unique understanding of the effects of RPN-002 and its role in creating conditions conducive to embryo implantation.”
Joan-Carles Arce, MD, PhD, Chief Scientific and Medical Officer, ReproNovo
The implantation process after embryo transfer is a key factor in determining the success of ART treatments. For many women and couples undergoing ART, each embryo transfer represents a significant medical, emotional and financial investment. Studies by different research groups have reported lower pregnancy rates in women with an increased frequency of uterine contractions during embryo transfer, indicating interference with the implantation process. With RPN-002, the Company aims to develop a therapy that may help improve some of the factors that impact successful embryo implantation and early pregnancy during ART treatment programs.
“Dosing the first participant in NORDIC is an important milestone for a study designed to better understand how uterine contractility may be managed around embryo transfer,” said Juan A. García Velasco, MD, PhD, Chief Scientific Officer of IVIRMA, representing the investigators of the NORDIC study. “Implantation remains one of the most critical and uncertain steps in ART, and data from this study may help inform future approaches to supporting patients undergoing fertility treatment.”
This milestone builds on ReproNovo’s progress advancing multiple global Phase 2 clinical programs across male and female fertility as well as women’s health, including RPN-001 for male infertility associated with low testosterone and RPN-002 for embryo implantation and adenomyosis.
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