ReproNovo has dosed the first participant in a European Phase 2 trial evaluating RPN-002, an oral therapy designed to improve embryo implantation during IVF and ICSI treatment.

ReproNovo has dosed the first participant in a European Phase 2 clinical trial evaluating RPN-002, an investigational oral therapy designed to improve embryo implantation and increase pregnancy rates in women undergoing assisted reproductive technology (ART).

The study, known as Nordic, is investigating RPN-002, also known as nolasiban, in women undergoing in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). The candidate is an orally administered oxytocin receptor antagonist developed to reduce uterine contractions during embryo transfer, creating conditions that may improve implantation and support early pregnancy.

The randomised, placebo-controlled, double-blind, parallel-group, multicentre Phase 2 trial will enrol 120 participants across five European sites. Researchers will evaluate two dosing regimens, including higher doses and a longer treatment schedule than those explored previously, to assess their effects on uterine contractility and endocrine parameters.

The company said the study is designed to generate pharmacodynamic data that will help identify an optimised dosing regimen for future clinical development.

Joan-Carles Arce, chief scientific and medical officer at ReproNovo, said: “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.”

Embryo implantation remains one of the greatest challenges in assisted reproduction, with implantation failure continuing to limit the success of IVF and ICSI despite advances in laboratory techniques and embryo selection. Research has suggested that excessive uterine contractions during embryo transfer may reduce the likelihood of successful implantation.

ReproNovo hopes RPN-002 can help address this by reducing uterine activity during the critical implantation window, potentially increasing pregnancy and live birth rates.

Juan García Velasco, chief scientific officer of IVIRMA, representing investigators in the Nordic study, said: “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.

“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.”

The first patient dosing marks continued progress across ReproNovo’s clinical pipeline in fertility and women’s health. Alongside RPN-002, the company is also advancing RPN-001, a Phase 2 candidate being evaluated for male infertility associated with low testosterone, while RPN-002 is also being investigated as a potential treatment for adenomyosis.

The company expects multiple Phase 2 clinical readouts across its fertility and women’s health programmes over the next two years as it continues development of both candidates.