Hair-Raising Follica Study Could Point to Baldness Therapy

6/3/13Follow @benthefidler

[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.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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  • julian

    http://www.uphs.upenn.edu/news/News_Releases/2012/03/hair/

    Well, that’s he (Cotsarelis) saying they would need to partner with a company to conduct the trials so as to respond that question.. can it reverse hair loss (used topically) or simply prevent it?

    • julian

      Now we know this company is Kythera (with Actelion agreement) and they’ve testing it for about 2 years…

  • julian

    “Setipiprant had previously been studied as a potential allergic inflammation treatment and had undergone eight clinical trials, including a Phase III study in seasonal allergic rhinitis patients and a Phase II proof of concept study in asthma patients, resulting in a safety database of more than 1,000 patients. Actelion suspended the development of setipiprant due to a lack of efficacy seen in the above-mentioned clinical trials for inflammatory disorders. Treatment in all studies was well tolerated across all treatment groups and no serious adverse events were reported.”

    MZ,

    My point is.. they were testing for safety, 1000+ patients… many of them should be hair loss sufferers obviously… so why didn’t they reported an incredible growth of hair? OR it should be that setipiprant would have to be applied topically to really have an effect in hair loss?

    • Mr. Z

      It’s possible that oral administration of the drug does not reach the active site, or that the doses used in those studies are not appropriate for hair growth. So, you may be correct when you ask if it has to be used topically. And/Or, maybe it needs to be used along with something else…for instance, wounding to generate regrowth.

  • McJ

    Old but interesting article that came on after the fgf9 news in 2013;

    http://www.biocentury.com/innovations/targetsmechanisms/2013-06-20/targets-and-mechanisms-fgf9-for-baldness-s7

    So many questions – and answers we’re not going to get anytime soon I reckon – but it would be interesting to find out how it translated to humans. Even if the hair was susceptible to the same process of loss, it would last for a good number of years. A hair cycle is pretty long. Fingers crossed we’ll hear about that Puretech money being pumped into Follica soon.

    • julian

      ow my god… 2013?? still fgf9?? Why Kythera didn’t sponsor it if it is so damn good? why didn’t Kythera partnered Follica then? Why are they just interested in the PGD2? Puretech won’t give a cent to Follica apparently. I don’t know how we are still talking about this company, and dreaming that they will show something anytime.. they don’t give a F… you know. That’s the truth.

  • julian

    WHY WOULD KYTHERA INVEST IN PGD2 KNOWING THAT FOLLICA IS DOING GREAT?

    • Vikki

      Maybe they, like pretty much everyone else, have no idea how well / not well Follica is doing, but have seen enough evidence of the efficacy of setipiprant to warrant investment?

      • julian

        But they have contact with George Cotsarelis, they would want to know that before investing, wouldn’t it? Cotsarelis works for Follica and is working for Kythera too? very odd…

        • Vikki

          I’m speculating wildly, here. But it’s entirely possible (very likely, actually) that Dr Cotsarelis has fingers in several pies, so to speak. For example, he is on Follica’s board, but also works at UPenn.
          The Follica approach / research is separate to this setipiprant stuff – it looks as though Kythera entered into agreements with Actelion (the developers of setipiprant) and UPenn, who published the PGD2 research. Very interesting that Kythera have been sponsoring research into this treatment at UPenn for the past 2 years, and have now (presumably) put more money into the project – which, to me, is a sure sign that there is a great deal to be optimistic about with regards to this potential treatment.
          I’m guessing that the Follica research is already covered by some other agreements, NDAs, patents, etc. and wouldn’t necessarily form part of discussions between Dr Cotsarelis and Kythera.
          Working in science myself, I can say it’s quite normal that an academic researcher may have several funding sources and will quite likely be involved in a number of separate projects, possibly with several different external partners.

          If I was being super-optimistic, I’d say that there are 2 possible treatments coming out of Dr Cotsarelis’ research. This is very good news – imagine, for example that Follica releases a product which is highly effective, but maybe only for 80% of people. If you’re one of the unfortunate 20%, or you’re allergic to the drug(s) used, then there’s another effective treatment from Kythera that might work for you.

          This situation would be sooooo much better than the current situation!

  • Vikki

    No idea whether this is noteworthy, but it is (to me at least) interesting…on Kythera’s executive team there are three individuals (Frederick Beddingfield, Elisabeth Sandoval, Ryan Irvine) who all previously worked for Allergan. The first two had some involvement with Latisse.

    • McJ

      Could be… Think there was a Neal Walker link to Allergan too, no? In any event, I guess we’re all kind of waiting to see what happens to that Puretech money and where it might go. There was a lot of unwarranted negativity around that for some reason but Follica were mentioned in a press release put out by Puretech themselves;

      http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=106278#.VO4JcPmsUdU

      Time will tell but the naysayers have, for some batsh#t crazy reason, been out for Follica for ages. They clearly have the best team in the biz and Follica outsourced a lot of their work hence all those departures from Follica a couple years ago. I’m thankful a company like that, success or not, exist. Cause any new treatment isn’t going to come from these armchair scientists or people who berate Follica for no reason. It’s a waiting game. Always has been and I get the frustration in that.

      • julian

        They just mention Follica as one of the companies that Puretech sponsor.. No mention as if they will grab a portion of that money.. yes, it’s a waiting game indeed, and it sucks cause we may be waiting for nothing since they don’t let us know anything, never.

      • Vikki

        I think he was at Allergan previously, now you mention it.
        I’m very thankful, like you, that Follica exists. Even if it ultimately fails, it’ll have moved hair regeneration research forward.
        I, personally, don’t think it will fail though. It’s taking longer than people would like, but there is obviously something good going on behind the scenes or they’d have wound the company up by now.

    • Julian

      Good to know that.. I think it is noteworthy FOR SURE.

  • julian

    A good sign that Follica is doing great would be an announcement of funding. We already know Puretech got money and would like to hear from them that some of it is going to Follica, they could just tell something about that, couldn’t they? they don’t need to tell nothing more than that.

    • julian

      Is it to ask too much?

  • McJ
  • julian

    how long it will take until we hear a word from Follica? or Puretech stating that it will give their share… frustrating to wait. Worrying…