In November 2019, ObsEva announced that nolasiban, its oral oxytocin receptor antagonist for patients undergoing in vitro fertilisation (IVF), failed to meet its primary endpoint in the Europe-based IMPLANT 4 trial.
The outcome was unexpected among investors and clinicians, most of whom anticipated highly favourable results from the first Phase III, IMPLANT 2, to be replicated.
IMPLANT 4 failed to demonstrate increased ongoing pregnancy rates at ten weeks in women undergoing a Day 5 single, fresh embryo transfer. Following the news, the company announced it would discontinue the nolasiban IVF program and explore options for repositioning the candidate.
With nolasiban being the only candidate under recent development with the potential to improve success rates per embryo transfer, GlobalData believes that the opportunity for developers to explore alternative development strategies is now not only amplified but also imperative, considering high demand in the fertility sector.
Primary and secondary research carried out by GlobalData identified the need for improving embryo implantation rates during IVF cycles. According to key opinion leaders (KOLs), despite significant developments in the field, as much as one-third of euploid embryos fail to implant during IVF cycles. This shows that there’s still a high demand for options that improve uterine receptivity during embryo transfers.
Embryo transfer is one of the most critical stages among the sequential steps of an IVF cycle. High-frequency uterine contractions (UC) during this stage have been previously recognised as one possible factor, which can prevent the success of IVF treatments.
Nolasiban had the potential to partially address this need by inhibiting uterine contractions and enhancing uterine receptivity. The drug was one step away from being filed for approval in Europe, along with ObsEva enrolling patients in a US-based Phase III trial. The drug’s recent failure is a disappointment but paves the path for new players to emerge.
At the ongoing JP Morgan Healthcare Conference in San Francisco, US, ObsEva outlined an opportunity to resume development of nolasiban through a new partnership with YuYuan Bioscience. However, despite plans for further investigation into the drug’s potential in China, the high demand for female infertility innovation is expected to remain unmet in the large US and EU markets.