Contraline, Inc., a clinical-stage biotechnology firm, has signed an exclusive option-to-license agreement with the Population Council for the Nestorone/Testosterone Transdermal Gel (NES/T) for male contraception. If the option is exercised, Contraline will lead the global development and commercialization of NES/T, solidifying its position as a leading company in male contraception. Contraline’s pipeline now features two groundbreaking, clinical-stage male contraceptives: NES/T, a daily-use topical gel, and ADAM™, a reversible implantable device.
NES/T, an investigational short-acting, transdermal, and reversible hormonal contraceptive, was developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the US National Institutes of Health. This daily-use gel, which combines Nestorone® (segesterone acetate) and testosterone, is applied to the shoulders to reduce sperm production. Over 750 men have participated in Phase 1 and 2 trials, with early results indicating NES/T’s potential as a highly effective male contraceptive with a favorable side-effect profile.
Globally, nearly half of all pregnancies are unplanned, translating to over 120 million unintended pregnancies annually. With current male contraceptive options limited to condoms and vasectomy, market research suggests that 15-17 million men in the United States would opt for new male contraceptive methods.
Kevin Eisenfrats, CEO and Founder of Contraline, stated, “Since our inception in 2015, Contraline has aimed to revolutionize male contraception. With no new options since vasectomy in 1897, NES/T and our ADAM™ device have the potential to redefine the landscape by offering men reliable, reversible, and appealing choices. Our collaboration with the Population Council and NICHD is a significant step in advancing global contraceptive solutions and promoting reproductive equality.”
Jim Sailer, Executive Director of the Population Council Center for Biomedical Research, added, “Contraline’s leadership in male contraception makes them an ideal partner for NES/T. Their mission aligns with our goal to expand contraceptive options for both men and women.”
Currently, NES/T is in a Phase 2b trial, enrolling over 460 couples across 17 global sites to evaluate its safety and effectiveness. Should Contraline exercise the option and after an end-of-Phase 2 meeting with the FDA, the company will initiate a Phase 3 program for NES/T. This would be the first Phase 3 trial in the US for a novel male contraceptive, marking a major advancement in the field.
Regine Sitruk-Ware, MD, a distinguished scientist at the Population Council and co-director of the Phase 2b trial, noted, “The acceptability of NES/T was exceptionally high, with participants eager to know when it will be available or to re-enroll. Female partners reported that NES/T was preferable to the female oral contraceptive pill.”
Dr. Alexander Pastuszak, Chief Medical Officer of Contraline, commented, “NES/T has the potential to offer a novel male contraceptive with comparable pregnancy prevention rates to some of the most widely used female contraceptives. We commend the Population Council and NICHD for their two decades of commitment to developing NES/T.”
Contraline remains dedicated to revolutionizing contraception by providing men with a range of effective, reversible contraceptive options that enhance reproductive freedom and responsibility.
