
The makers of a non-hormonal male contraceptive just announced a key milestone during their first human clinical trials, with the treatment demonstrating safety and efficacy at the two-year mark. The next step is Phase 2 trials, and if all goes well, developers Contraline, Inc. believe their product could come to market before the end of the decade.
The treatment is called ADAM™, and it works by temporarily blocking the transit of sperm through the vas deferens, the long muscular tube that connects the testes and urethra.
The injectable hydrogel, administered within a 30-minute appointment, prevents sperm movement without blocking ejaculation or affecting sexual sensation. At the end of its lifespan, the developers say, the gel will harmlessly liquefy and sperm flow will be restored.
This mechanism sets ADAM™ apart, as Contraline CEO Kevin Eisenfrats told IFLScience. “No other method can provide long-lasting (two years), non-hormonal, and temporary contraception.”
I believe we’re now closer than ever to figuring out the science piece.
Kevin Eisenfrats
The simplest way of preventing your little swimmers getting up the vas deferens is to cut and seal the tube – this is what happens during a vasectomy, and while it can be a reversible procedure, there are no guarantees reversal will work, so it’s considered a form of permanent contraception.
If you want something more temporary, for those in possession of a male reproductive system, your options are extremely limited. Basically, it’s condoms.
People have been trying to remedy this for years. There have been genetic breakthroughs, promising protein inhibitors, even sperm “paralyzers” – and still, the promise of a male birth control pill seems as far away as ever. There are even other approaches similar to ADAM™, which work by blocking the vas deferens.
These approaches are appealing for the same reasons as the female contraceptive implant or IUD – once it’s in place, you theoretically don’t have to think about it again for months or even years. There’s no remembering to take a pill every day.
Eisenfrats believes that even within this field, ADAM™ stands apart.
We have a waiting list of 15,000+ men.
Kevin Eisenfrats
“Other vas-occlusive methods are designed to be permanent and require a second procedure to remove the implant, but as we know, the longer the vas is occluded, the harder it becomes to successfully reverse. Vas-occlusion is nice in that it is ‘set and forget’ and the mechanism of action is to block sperm right at the source without affecting anything else in the body,” he told IFLScience.
Ultimately, the goal would be for male and female contraceptives to be available in a similar range of choices. “We understand that not every guy may want to get a procedure. Some may truly prefer a pill or daily gel, which is great,” Eisenfrats said. “We need to offer men a bunch of options.”
Contraline’s latest announcement is an update on the first-in-human trials of ADAM™ now that some patients have reached the two-year milestone. Two patients have been shown to have azoospermia – an absence of viable sperm in their semen – 24 months after the administration of the hydrogel. Other patients who were recruited later are still in the trial, with successful contraceptive efficacy being shown at 12, 15, 18, and 21 months.
No participants have experienced serious adverse effects from the treatment, meaning the study team is confident in progressing to Phase 2 trials, for which they’ve now received approval. Eisenfrats told us they hope to recruit 30 people at a minimum, starting in the fall of this year.
And if all goes well? “We believe ADAM™ will be available by the end of this decade, and potentially as soon as 2028,” he said.
Recruitment is unlikely to be a major barrier, if the interest in Contraline’s products is any indication. “[We] have a waiting list of 15,000+ men (without any advertising/marketing) and what we have found is that a large percentage of men want a quick and minimally invasive procedure like ADAM™ that offers years of non-hormonal birth control,” Eisenfrats told IFLScience.
If ADAM™ were to progress successfully through all the stages of a clinical trial, it would be a first.
“Researchers have been working on male contraception for 60+ years, but there has never been a method that has shown full safety, efficacy, and reversibility beyond Phase 2 trials,” said Eisenfrats. “With recent advancements in drug development and medicinal chemistry, biology, including identification of new targets, and new materials for vas-occlusion, I believe we’re now closer than ever to figuring out the science piece.”
So, maybe now is the right time – perhaps ADAM™ will be the treatment that finally breaks the deadlock and sets us on the path to a greater range of male contraceptive options. For Eisenfrats, society’s appetite for it, at least, is in no doubt.
“[I] also do believe men are more ready for new male contraceptives now than they were 20, 30, 40 years ago. There’s no question that there is demand from consumers.”
Source Link: Sperm-Blocking Male Contraceptive Could Hit The Market "As Soon As 2028" After Promising 2-Year Trial Results