Amid changing attitudes toward family planning and contraception, and as the rise of telemedicine companies like Hims & Hers and Roe define a new era of consumer-driven health care, the lack of drug treatment options for male contraception has become noticeable.
Recognizing that gap, Charlottesville, Va.-based Contraline has developed what it believes could be a high-profile first-in-class candidate, and is currently developing what is garnering enthusiasm from many big-name investors.
On Tuesday, Contraline announced the completion of a $92.5 million Series B funding round co-led by venture capital giants BVF Partners and RA Capital Management. In the funding, the company, founded in 2015, also attracted support from GV (formerly Google Ventures), Lumira Ventures, Invus, and other new and existing investors, according to a June 2 release.
Contraline currently plans to use the proceeds, first and foremost, to advance late-stage development of its potential first-in-class male contraceptive candidate, NES/T Gel.
Currently, contraception for men revolves around condoms and vasectomies, and there are no drug-based options comparable to oral contraceptives or implants that women can use to prevent pregnancy.
But the shortage of drug-based contraceptives for men isn’t for lack of trying, Contraline co-founder and CEO Kevin Eisenfratz said in an interview with Fierce. He noted that research into male contraception has continued for about half a century, almost “in parallel with female contraception,” but challenges still loom.
At first glance, Eisenfratz explained that designing a product that can block hundreds of millions of sperm, rather than one egg once a month, with the safety standards necessary for use in healthy people is a major challenge.
The CEO also pointed to “long-standing funding challenges” and noted that contraceptives “are not a well-funded area compared to other areas of drug development.”
Contraline’s candidate NES/T is a hormone-based male contraceptive that is administered as a topical gel that combines the synthetic progestin segesterone acetate (also known as Nestorone) and testosterone. This NES/T cocktail is designed to suppress sperm production while maintaining physiological testosterone levels in men using contraceptives.
NES/T was originally developed by the research organization Population Council and the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), but Contraline has since secured worldwide rights to develop and commercialize the program.
The segesterone acetate ingredient in Contralin’s gel was approved in the U.S. in 2018, making it another approved contraceptive, albeit for women, in the vaginal ring contraceptive Anovella, sold by Maine Pharma.
The overall goal behind wedding testosterone with segesterone acetate is to “minimize the side effects of basically having low or high T levels,” Eisenfratz said, referring to serum testosterone levels. Progestin alone can suppress a man’s hormone levels and stop sperm production (unlike hormone-based birth control in women), but doing this without some kind of balance can cause testosterone levels to drop.
Contraline’s new Series B funding follows NES/T’s recent completion of a Phase 2b study that enrolled 462 couples worldwide, which the company said “demonstrated encouraging efficacy, tolerability, reversibility, and user acceptance.”
Contraline currently plans to begin Phase 3 development of the program in 2027.
Eisenfratz said that while he was encouraged by the Phase 2b data for NES/T-gel, the question of how to fund Phase 3 of experimental male contraceptives had been lingering even before the funding round, noting that “big pharma is actually kind of avoiding this space.”
With major investors such as BVF and RA Capital now on board, Contraline will have enough cash to fund its entire Phase 3 trial up until filing for FDA review, he said.
Meanwhile, apart from NES/T, Contraline is also developing ADAM, a non-hormonal long-acting male contraceptive that is under investigation.
While NES/T is Contraline’s main priority for now, the company is aiming to:of “We’re a male contraceptive company,” Eisenfratz said, noting that proceeds from the Series B will also fund mid-term testing of ADAM.
The goal behind ADAM, which Eisenfratz described as a “brainchild,” is to develop a hormone-free implantable contraceptive for men that is reversible and remains effective for several years.
“This is not a competitor or replacement for a vasectomy,” Eisenfratz noted. Contraline plans to begin a Phase 2 program from its assets again next year, he said.
Eisenfratz speculates that recent societal changes have created male contraceptive options like NES/T.
In the 2000s and 2010s, and “particularly” in the last decade, “we saw a huge peak in demand in terms of men coming forward and saying, ‘Enough is enough. Why are so many women in this? How can I play a role in family planning?'” the CEO explained.
“I don’t think people were necessarily ready for this 20, 30 years ago,” he added.
“I think in general, we currently look at the men’s health space as a huge blank space,” Eisenfratz said. Meanwhile, he added, companies like Hims & Hers and Roe are demonstrating through their consumer telemedicine models that “men are active participants in their health care, and they’re willing to buy their medications. We just need to make it convenient and accessible for men.”
Eisenfratz said that even 10 years ago it would have been unthinkable for Contraline’s company to launch its own new drug, but the current reality is that “it’s definitely a possibility.”
When asked about the company’s potential marketing strategy if NES/T is ultimately approved, he said, “We’re not closing the door.”
