Contraline, a clinical-stage biotech firm, has signed an option-to-license agreement with the Population Council for the Nestorone/Testosterone Transdermal Gel (NES/T) for male contraception.
When the option is exercised, Contraline will lead the global development and commercialisation of NES/T.
Contraline’s pipeline now features two clinical-stage male contraceptives including NES/T, a daily-use topical gel, and ADAM, an implantable, reversible device.
NES/T is an investigational, short-acting, transdermal hormonal contraceptive.
Developed by the Population Council and the National Institute of Child Health and Human Development (NICHD), it is part of the US National Institutes of Health (NIH).
The NES/T gel, which contains Nestorone (segesterone acetate) and testosterone, is designed for daily application on the shoulders. The gel aims to reduce sperm production.
More than 750 men have used NES/T in Phase 1 and 2 trials. Preliminary data indicates that NES/T could be a highly effective male contraceptive with a manageable side-effect profile, the clinical-stage, biotechnology company said.
Contraline CEO and founder Kevin Eisenfrats said: “Since founding Contraline in 2015, our vision has been to pioneer new male contraceptives and establish the industry from the ground up.
“With no new male contraceptives introduced since the vasectomy in 1897, our products, NES/T and ADAM, have the potential to change the paradigm by providing men with reliable, reversible, and appealing options. Our goal is to offer a ‘toolbox’ of choices to fit each individual’s lifestyle.
“This partnership with the Population Council and NICHD marks a major leap forward in our mission to transform global contraceptive solutions and promote reproductive equality.”
The announcement coincides with NES/T completing a Phase 2b trial, which includes over 460 couples at 17 global sites to evaluate safety and effectiveness in preventing pregnancy.
This will be followed by an end-of-Phase 2 meeting with the US Food and Drug Administration (FDA). The biotech will then initiate a Phase 3 programme for the transdermal hormonal contraceptive.
The late-stage trial will be the first of its kind for a male contraceptive in the US.
Population Council Center for Biomedical Research executive director Jim Sailer said: “Contraline is a leader in the male contraceptive field, making them a natural potential partner for the NES/T gel.
“Contraline’s goal to offer new methods of male contraception fits with our mission to provide women and men more contraceptive options.”
