Amid shifts in attitudes around family planning and contraception—and as the advent of telehealth outfits like Hims & Hers and Ro defines a new era of consumer-driven healthcare—the lack of a medication option for male birth control has become glaring.
Recognizing that gap, Charlottesville, Virginia’s Contraline is stepping up to the plate, developing what it believes could be a first-in-class topical candidate that has now garnered enthusiasm from a host of big-name investors.
On Tuesday, Contraline unveiled the close of a $92.5 million series B financing round, co-led by venture capital heavyweights BVF Partners and RA Capital Management. The fundraise also saw the company, founded in 2015, garner support from GV (formerly Google Ventures), Lumira Ventures, Invus and a mix of other new and existing investors, according to a June 2 release.
Contraline now plans to use the proceeds, first and foremost, to propel its potential first-in-class male contraceptive candidate NES/T Gel into late-stage development.
As it stands, male contraception revolves around condoms and vasectomies, with no medication-based options on par with the birth control pill or implants that women may use to prevent pregnancy.
But that dearth of drug-based contraceptives for men isn’t for lack of trying, Kevin Eisenfrats, Contraline’s co-founder and CEO, said in an interview with Fierce. He noted that work has been ongoing on male contraception for about half-a-century, nearly “in parallel with female contraceptives,” but challenges have nonetheless stood in the way.
On its face, designing a product capable of stopping hundreds of millions of sperm as opposed to a single egg once a month, and at a safety benchmark necessary for use in healthy people, is a big challenge, Eisenfrats explained.
The CEO also pointed to “funding challenges over the years,” noting that contraception is “not a well-financed area versus some of the other areas of drug development.”
Contraline’s candidate NES/T is a prospective hormone-based form of male birth control administered as a topical gel, which combines the synthetic progestin segesterone acetate—also known as Nestorone—with testosterone. This NES/T cocktail has been designed to suppress sperm production while maintaining physiological testosterone levels in men using the contraceptive.
NES/T was originally developed by the research organization, the Population Council and the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), although Contraline has since secured global rights to develop and commercialize the program.
The segesterone acetate component of Contraline’s gel has made it into another approved contraceptive product, albeit one for women, in the vaginal ring contraceptive Annovera, which won U.S. approval in 2018 and is marketed by Mayne Pharma.
The overall goal behind wedding testosterone with segesterone acetate was to “minimize side effects, basically of having low or high T,” Eisenfrats said, referring to serum testosterone levels. While a progestin alone could suppress hormone levels in men to stop sperm production—not unlike hormone-based contraception for women—doing so without some sort of balance has the potential to lower testosterone levels.
Contraline’s new series B cash infusion follows NES/T’s recent completion of a phase 2b trial enrolling 462 couples globally, which the company has said “demonstrated encouraging efficacy, tolerability, reversibility, and user acceptability.”
Now, Contraline anticipates kicking off phase 3 development for the program in 2027.
While encouraged by the phase 2b data on its NES/T gel, the question of how to fund a phase 3 for the experimental male contraceptive persisted prior to the fundraising round, Eisenfrats said, noting that “Big Pharma really has kind of sidestepped this field.”
Now, with major investors like BVF and RA Capital onboard, Contraline will have enough cash to fund its entire phase 3 trial through to a review submission with the FDA, he said.
Apart from NES/T, meanwhile, Contraline is also developing ADAM, an investigational non-hormonal, long-acting male contraceptive.
While NES/T is Contraline’s main priority for now, the company aims to be “the male contraception company,” Eisenfrats stressed, noting that proceeds from the series B will also help fund the midstage testing of ADAM.
The goal behind ADAM, which Eisenfrats described as his “brainchild,” is to develop a non-hormonal implantable contraceptive for men that lasts for a few years while still being reversible.
“It’s not a competitor or replacement of vasectomy,” Eisenfrats pointed out. Contraline expects to start its phase 2 program from that asset next year as well, he said.
In recent years, a societal shift has occurred that’s set the stage for a male contraceptive option like NES/T, Eisenfrats figures.
From the 2000s to the 2010s and “especially” now in the current decade, “we’ve seen a massive peak in demand in terms of men stepping forward and saying, ‘Enough; Why is this only falling on women, and how can I play a role when it comes to family planning?’” the CEO explained.
“I don’t think people were necessarily ready for this twenty, thirty years ago,” he added.
“I think in general we see the men’s health space as a massive white space right now,” Eisenfrats said. Companies like Hims and Hers and Ro, meanwhile, have demonstrated through their consumer telehealth models that “men are willing to engage in healthcare, they are willing to buy drugs—you just have to make it convenient and accessible for them,” he added.
While it would have been unthinkable for a company to Contraline to launch its own drug even ten years ago, Eisenfrats said, the reality now is that it’s “definitely a possibility.”
“We’re not closing that door,” he said when asked about the company’s potential marketing strategy, should an approval for NES/T eventually come through.