June 2019 Follica UPDATE!
Yesterday, we received an update from Follica on their development for their ongoing study to treating hair loss. For those who are new, Follica is a biotech company that is currently developing a regenerative platform to treating hair loss. Their device platform has shown to stimulate the development of new hair follicles from 3 previously conducted clinical trials, and Follica’s proprietary device is designed to induce an embryonic window via a device that looks like a micro-needling device, with optimized parameters to create micro-wounds and initiate hair follicle neogenesis, the formation of new hair follicles from epithelial stem cells. This process is enhanced through the application of a topical compound which has not been disclosed yet. Follica’s ongoing optimization trial, along with a pivotal study in those suffering from androgenic alopecia, is expected to begin at the end of Q4 of 2019.
Follica announced positive interim data from an ongoing safety and optimization study to treat hair loss in male pattern hairloss. In addition to being well tolerated and informing key treatment parameters, analysis of 20 male study participants with androgenic alopecia showed that Follica’s approach achieved a visible and statistically significant improvement in non-vellus hair count after 3 months of treatment, compared to baseline.
In addition, blinded head to head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices, which I feel is mostly contributed to their topical compound which they have no released information on. Commercially available skin disruption devices would include things like a derma stamp, derma roller, Dr. Pen, etc. This statement alone means that Follica acknowledges the benefits micro-needling has in re-growing hair, along with the countless number of scientific studies that really show micro-needling’s efficacy in hair growth. A pivotal study, as I mentioned, is expected to start at the end of 2019 and subject to continued safety and efficacy in the optimization study.
Per the press release, the next official trial for Follica will involve an end-blinded, randomized controlled study to determine the Follica skin disruption device’s efficacy, including optimal duration and frequency of the treatment. The study will continue to enroll up to 60 men, between the ages of 18-40 and those suffering from a Norwood 3 to a Norwood 4, which is great since most of us baldies tend to fall into that NW 3-4 category.
As far as phase 3 trials go, it would have to take at least a minimum of 6 months to a year, so we still have to wait a couple years at minimum before this product will be out on the market. The other important thing Follica has yet to address is their topical compound. Many speculate that it is going to consist of an ingredient that is already approved by the FDA for hair loss, such as minoxidil or something similar, but their plan is to most likely use a WNT activator compound. All in all, Follica won’t be a complete cure to hair loss, in my opinion, but rather an upgraded tool that can help maintain hair and regrow miniaturized lost hair through their better devised skin disruption device and hair loss topical. That’s basically what I think it is: an upgraded FDA approved micro-needling device used with some type of hair stimulating topical. I was lurking on one of the hair loss blogs at hairlosscure2020 and the moderator has stated that one of Follica’s clinical advisers, Dr. Bhanusali has agreed to answer reader questions, so check that out if you have any questions regarding Follica. People already left some good questions that has yet to be answered, including things like the cost of the treatment, projected date before it’s available, duration and maintenance of treatment, etc. Certain questions can’t obviously be answered due to investment partners within Follica but if you guys have any questions, it certainly wouldn’t hurt to ask.
Let me know what your thoughts are on Follica and what you expect Follica to be when it is released out in the market.