Health and Medicine
PUBLISHED
As far as scientific innovation and breakthroughs have brought us in medicine, there are some problems that remain stubbornly out of reach. Take hair loss, for example: it affects almost half of us, with the majority of men and more than one in three women going thin on top by age 65 – and yet effective, approved treatment options are currently almost non-existent.
The rest of this article is behind a paywall. Please sign in or subscribe to access the full content.Fairly soon, however, the number of available treatments may grow. Veradermics, a biopharmaceutical company with a focus on hair loss, has been developing a new drug for both women and men to regrow their once-thick locks – and it’s just passed one of the last hurdles to entering the market.
“Our proprietary […] formulation delivered marked increases in hair growth as assessed by objective assessments as well as physician and patient reports in Study ‘302’,” announced Veradermics CEO and dermatologist Reid Waldman, in a statement provided by the company.
“We are optimistic that these [Phase 2/3 trial] results represent a defining milestone for the hair loss community, our company and investors as we advance this foundational, non-hormonal treatment approach to the clinic for the millions of people with pattern hair loss.”
Named VDPHL01 – though we have to assume it’ll get a snappier moniker if it hits the shelves – the drug is actually kind of like Rogaine®: it’s based on minoxidil, which is the generic name for the now legacy-status hair loss treatment.
The most obvious difference is in the delivery system, with the new drug being taken orally instead of topically – that is, you eat it instead of rubbing it in.
Even that distinction, however, is not exactly new. Oral minoxidil has actually been in use since the 1970s – just for the heart, rather than the head.
“Dermatology has been treating hair loss with a drug borrowed from cardiology, in a formulation never intended for our patients, at doses we arrived at informally,” said board-certified dermatologist Michael Gold, who worked on the drug trial. “VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety.”
You might think, since Rogaine has been on the market since 1991, that oral minoxidil was kind of an obvious choice for a hair loss treatment – but until now, there’s always been a problem.
Basically, it’s too effective: taken by mouth, “it comes into the body very quickly,” Waldman told Harper’s Bazaar in October last year, with the effect of immediately relaxing a person’s blood vessels. “[It’s] really great if you want to rapidly control someone's blood pressure. It's not so great for driving hair growth with reduced cardiac risk.”
That’s why VDPHL01 is designed to release its active ingredient far more steadily. “The idea here is that we want to give consistent exposures at the hair follicle to the minoxidil with a slow release, via a proprietary hydrogel technology,” Waldman said.
It’s doubly beneficial: not only should it avoid the unwanted side effect of blood sloshing aimlessly around in your body while your heart uselessly pumps itself to bursting, but it also keeps the amount in your system high enough to actually be effective for your hair.
And, so far at least, the formula seems to be working. Veradermics says that after six months of treatment with the drug, more than six out of every seven of the 500-plus study participants reported improvement in their hair coverage. More objective measures bore this out as well, with hair counts revealing about four times as much regrowth for those on the drug as for those on a placebo.
This isn’t the end for Veradermics’ trials: they already have a phase 3 trial for men lined up, and are currently recruiting for a phase 2/3 trial for women. If VDPHL01 is approved, it would be the first ever oral hair loss treatment approved for women. Exactly when we should expect the drug to be available is unfortunately unknown – although, typically, the FDA expects at least two successful phase III studies before approving a drug, so it’ll probably be some time from now.
Still, if these results hold up, perhaps it’ll be worth the wait. “Based on the results of the ‘302’ trial, VDPHL01, if approved, has the potential to transform how physicians and patients approach pattern hair loss for men,” said Maryanne Makredes Senna, a dermatologist at Beth Israel Lahey Health, Assistant Professor of Dermatology at Harvard Medical School, and member of Veradermics’ scientific advisory board.
“I believe that an oral therapy that has improved hair loss in the eyes of nearly 80 percent of patients and investigators, was generally well tolerated in trials and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss.”
