[Updated, 11:00 am ET] Few stories have struck a chord with Xconomy’s readership quite like that of Follica, the PureTech Ventures-incubated startup founded in 2006 with plans to combat male and female pattern baldness by using adult stem cells to grow new hair follicles. Unfortunately, details regarding Follica’s science—let alone its clinical progress—have been as tough to spot as a good toupee.
Boston-based Follica and the man behind its technology—University of Pennsylvania stem cell biologist George Cotsarelis— at least partially lifted the lid (or wig?) on those secrets today with two announcements: First, a research team led by Cotsarelis has identified a key protein that could potentially be used therapeutically to help people grow new hair follicles; Cotsarelis has published the results of that study in Nature Medicine. Secondly, Follica claims to have used its technology in a procedure that successfully grew new hair follicles in humans in a clinical trial. [An earlier version of this story indicated that Follica used that protein, Fgf9, in its clinical trial. Olle later clarified that the protein, Fgf9, has only been involved in Follica’s preclinical work so far].
Even so, a number of questions remain. Follica provided little else in terms of specifics—for example, how many people are in the trials, where they took place, the extent of those results, exactly what its next study will look like, or roughly how long it will take for these findings to turn into a real live procedure sold on the market. It is similarly evasive as to the details of the procedure it is devising.
“We’ve had to be careful about how we deliver the news because there’s all these huge responses,” says Follica co-founder and PureTech principal Bernat Olle.
For those new to the Follica story, here’s the synopsis: Research that Cotsarelis conducted at his lab at Penn showed that new hair follicles would form at the center of some skin wounds. The general concept is that when the top layers of the skin are removed, the skin cells underneath are essentially in a primitive, embryonic state at which they can form new skin, new hair follicles, and ultimately new hair. Follica’s quest has been to devise a procedure-drug combination to take advantage of that window of time and direct the cells to form new hair follicles.
Now Cotsarelis appears to have found the catalyst that could potentially turn that idea into a treatment. Cotsarelis and his team have homed in on a protein known as fibroblast growth factor 9, or Fgf9, that they believe to be implicated in the growth of hair follicles. Fgf9—which is found in short supply in humans, according to Olle—is part of a family of proteins formed by cells in the skin that perform a variety of biological functions such as wound healing. The researchers found in the study that cells produce a lot of Fgf9 right before a new hair follicle forms on a layer of skin. So by increasing Fgf9 while the skin is regenerating, researchers could potentially direct the skin to form new hair follicles.
“It draws a very clear link between tissue regeneration and the skin immune system,” Olle says. “It opens the way to therapeutically intervene in humans with the approach.”
Follica’s idea, then, is to use its proprietary devices—around which Olle says the company has a broad group of patents—to induce this process to occur, and then add Fgf9. What this would lead to, in theory, is a hair-raising procedure: a doctor would use a device specifically created by Follica to remove the top layers of the skin in a targeted area of hair loss. (Olle says the procedure isn’t painful, but the area could be numbed anyway.) While the skin is in this state, the doctor would then apply a drug. Olle declined to specify what type of drug this would be, whether that drug would contain fgf9, or if the procedure/drug combination would induce the body to produce fgf9 on its own. He did say, though, that the company has been doing a lot of work with topical formulations that are applied directly to the skin.
Follica said in its statement that it has already done preclinical tests that combine devices it has created to disrupt the skin with several unspecified “known and novel drugs.” It also claims to have run “a series” of human clinical trials, including a mid-stage study that has caused new hair follicles to be produced in humans. Unfortunately for our rabid readers, however, Olle and Follica aren’t offering many details from these studies, other than to indicate that the platform is proving to work so far and that the research has paved the way for the company’s next step: to try a specific device configuration with a specific, well-known and studied drug (meaning it wouldn’t have to be as extensively tested as a new chemical) in a group of human patients.
“We’ve been able to consistently show that we crate substantial new hair follicles in humans, and that’s something that no other approach in hair loss as far as I am aware has been able to achieve,” Olle says. “That’s a critical step. The goal of some of those early trials has been to test the hypothesis of the mechanism that we had seen in mice.”
Follica would still have to determine in longer trials and follow-ups with patients, for example, how long the new hair lasts so as to know if patients would have to get another procedure down the road.
Olle and PureTech managing partner Daphne Zohar co-founded Follica in late 2006 along with Cotsarelis, Harvard Medical School dermatologist Rox Anderson, and Vera Price, the director of the University of California, San Francisco Hair Research Center. Kirk Raab, the former CEO of Genentech, is the company’s chairman. William Ju, a board certified dermatologist who formerly worked at Merck Research Laboratories, Pharmacia, and PTC Therapeutics, became CEO in May 2009. The company has raised $19 million in financing through two rounds since its inception, according to Olle.
The interest in Follica’s pursuit has been enormous at Xconomy. Put it this way: our last story was written in 2011 and it is still serving as a defacto message board on the topic. Some 2,000 comments have been posted. That, if nothing else, shows the intense interest surrounding the company’s work.
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