San Diego’s Histogen, a regenerative medicine company with technology for using nascent skin cells to produce “cosmeceutical” products, says the FDA has given a green light to its application for an initial safety study of its hair stimulation product in women.
In the United States, Histogen says hair loss affects over 40 million men and 21 million women. According to the company, less than 7 percent of them seek treatment, “largely due to the ineffectiveness of currently available options,” and a general reluctance to undergo hair transplant surgery.
Histogen is trying to provide a new option with a product known as Hair Stimulating Complex (HSC) that is injected into the scalp. The company says HSC contains growth factors and related substances secreted by cells grown under simulated embryonic conditions in its “bioreactors.”
Based on studies conducted on less than 100 patients in Honduras and the Philippines, and a 10-patient physician-sponsored study in the United States, Histogen contends that HSC triggers stem cells in the scalp to form new hair follicles. (Histogen before-and-after images of a woman enrolled the physician-sponsored study are above.)
The company submitted its initial application for the clinical trial in late 2015.
In response to a query from Xconomy, Martin Latterich, Histogen’s vice president of technical operations, said the long delay was due to a number of requests the FDA made in response to the company’s original submission, “particularly relating to the characterization and manufacturing controls of the HSC product.
“These requests underscore the fact that HSC is a first-in-class biologic, requiring development of a unique regulatory approach,” Latterich wrote in an e-mail. “Over the last two years, Histogen has been working to develop a product characterization strategy and novel characterization methods to meet the FDA’s requests, and submitted a revised package in April 2018 which led to the IND [Investigational New Drug] approval the company received this week.”
Histogen now has the regulatory go-ahead to begin an early stage safety study of HSC in women as a treatment for alopecia, a type of hair loss believed to be caused by autoimmune disease. While the FDA has approved the use of finasteride (Propecia) to promote hair growth in men with male pattern baldness, there are no currently approved hair re-growth treatments for women in the United States, Histogen founder and CEO Gail Naughton said Friday.
Funding difficulties have constrained Histogen’s ability to advance its product. The company announced in 2016 that it had raised $6 million from an affiliate of Huapont Life Sciences, a healthcare products company based in Chongqing, China, and was laying plans to raise an additional $18 million in a Series D financing round. At that time, Histogen said it had raised a total of roughly $33 million since the company was founded in 2007.
Histogen’s Naughton said additional clinical data could help drive a higher valuation for the company, which might help Histogen raise additional equity funding on acceptable terms. Total invested capital raised by Histogen now stands at $35 million, she said.
Histogen secured additional (undisclosed) working capital under an agreement reached last July with Allergan (NYSE: AGN) that enables Allergan to incorporate Histogen’s proprietary cocktail of naturally-secreted growth factors in its Regenica product for topical applications in medical use. Histogen has been looking for a similar arrangement with another partner that would take the company’s proprietary growth factors into retail cosmetics.
Naughton said Histogen also is moving toward a late-stage clinical trial in Mexico for use of its HCS in men for treating baldness.
“We’re not trying to preclude men” in the U.S. from the early-stage trial for women that Histogen will soon start, Naughton explained. “We can only do so many trials at the same time.”
The company’s regulatory hurdles are higher in the U.S., largely because Histogen must demonstrate the safety and effectiveness of its product across a broad range of diverse ethnic groups, Naughton said.