Experimental Drug Shows Early Promise In Treating Male Baldness
Matthew Herper , FORBES STAFF I cover science and medicine, and believe this is biology's century.
MAR 5, 2016 @ 01:10 PM
Source: forbes.com
An experimental drug from a largely unknown biotechnology company has shown promise in regrowing bald men’s hair, according to data to be presented at the American Academy of Dermatology in Washington, D.C., today.
Source: forbes.com
An experimental drug from a largely unknown biotechnology company has shown promise in regrowing bald men’s hair, according to data to be presented at the American Academy of Dermatology in Washington, D.C., today.
The result is preliminary, and doctors who reviewed the presentation ahead of publication for Forbes characterized the results as promising, but also raised concerns about whether or not it would hold up in larger studies.
Drug maker Samumed, based in San Diego, says that it will be taking the medicine, code named SM04554, into larger studies aimed at getting approval from the Food and Drug Administration. The treatment is a topical solution that is rubbed on the head. It works, Samumed says, by affecting the Wnt pathway, a fundamental signaling pathway discovered in fruit flies (w stands for “wingless”) that is crucial in the development of embryos and in cancer in all animals. The results will be presented today by Yusuf Yazici, Samumed’s chief medical officer.
In the study, 300 patients were assigned randomly either to get a placebo version of the topical solution without any drug, a 0.15% solution of SM04554, or a 0.25% solution of SM04554. The medicine seemed generally safe.
Patients who took the drug seemed to see the number of hairs in a one square centimeter area of their scalp increase, while those in the control group lost hair. In the control group, hair count dropped from 114 hairs per square centimeter to 111.5. In the 0.15% group, hair count increased from 104.9 to 115. In the 0.25% group, hair count increased from 110.8 to 118.5.
Similar results were seen on another measure, called hair density. Samumed is not presenting the results on self-reported measures of hair quality, another measure of efficacy, at this time. The differences between the 0.15% group and the vehicle were statistically significant.
One concern here is that the drug is more effective at a lower dose than a higher one. Usually drug makers like to see what’s called a dose response: You give more drug, you get more efficacy and side effects. For some companies, lack of a dose response can be seen as reason to cancel a drug development program. Samumed says this mirrors what it sees in animal models with its drug, where there is a “Goldilocks” effect of having to hit just the right dose.
Daniel Zelac, a dermatologist at Scripps Health in La Jolla, Calif., says that the loss of hair in the vehicle group was larger than he’d expect. “I think at best they are presenting a trending,” he said.
“What we need are further studies to better evaluate safety efficacy and appropriate dosing regimen,” echoes Rochelle Torgerson, an assistant professor of dermatology at the Mayo Clinic in Rochester, Minnesota.
Still, Torgerson says, she’s excited by the effort and early promise. Half of men, she notes, lose their hair due to what’s known as androgenic alopecia. For many, it’s a huge quality of life factor. “There’s not a lot of new treatment options just flowing forth for hair loss, let alone, androgenetic alopecia for men.”
There hasn’t been much movement in hair loss for decades. Rogaine, a topical treatment that slows hair loss but does not cause regrowth, was approved in 1988. Propecia, a pill to treat male pattern baldness that has become controversial because some users report serious side effects.
Recently, there has been a bit of an uptick in interest in hair loss drugs. Most prominently, Allergan is testing Latisse, its drug for lengthening eyelashes, as a hair loss treatment.
