Follica Announces Positive Data 2019
Boston based hair growth company Follica has announced positive data from its ongoing safety and optimization study and is prepared to move into a pivotal FDA study later this year.
Upon checking my email this morning I found a message from a top level executive at Follica pointing me to a press release sent out by the company this morning. The press release has shown up on Yahoo Finance and Business Wire and is titled “Follica Announces Progression to Pivotal Study Following Positive Interim Data in Male Androgenetic Alopecia.” According to the press release, the safety and optimization study which is currently ongoing has analyzed 20 male participants with androgenic alopecia and has “showed a visibly and statistically significant improvement in non-vellus hair count after 3 months of treatment.”
Also, a very interesting detail from the press release states that head to head testing of the proprietary Follica device showed significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. Commercially available devices most people are familiar with include dermapens, dermarollers, etc. So, the press release claims this new device is an improvement in wounding options.
A Graphic Of Follica’s Skin Disruption Devices
Quotes
Here are some key quotes from Follica personnel in this press release:
“Some of my past life was spent trying to stop hair from growing, but I’m equally enthusiastic to have been involved in helping advance and optimize George’s key discovery that shows promise for creating new hair,” – R. Rox Anderson, MD, PhD. This is interesting because he references creating new hair and not just thickening existing hair.
“The biology of wounding in humans is very complex, and our ability to translate its effects into new hair growth is sensitive to a range of treatment factors…… From years of clinical testing, we have optimized the dosing, frequency, and several other important parameters and translated these learnings into a unique and proprietary treatment.” – Jason Bhardwaj CEO. This quote continues in the theme of creating new hair growth and delves into some of the parameters that Follica has studied to create a unique treatment.
FDA Approval Study
According to the press release, the next official trial for Follica is going to be an endpoint-blinded, randomized, controlled study designed to evaluate Follica’s proprietary skin disruption device in men with androgenetic alopecia and to establish therapeutic parameters, including the optimal duration and frequency of treatment. The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV).
Endpoint-blinded means that the areas being measured will not be known by those who administer the treatment or the patient during the study. Another key mention above is the disclosure of the Norwood grades which will be tested in this study, 3 and 4. Those are reasonable Norwoods to observe and I’m sure many people will be eager to see what Follica’s R.A.I.N. treatment can do for treating a Norwood 4 patient. Below are some examples of a Norwood 3 and 4 from norwoodscale.com.
Norwood 3
Norwood 4
Thanks for linking to this article when sharing and please let me know what you think about Follica’s news in the comments!
Posted in Follica, Hair Growth Treatment
Great news
But when about the availability of treatment
I am confused and just want some clarity. Are they simply devising a better “skin disruption” device to be used with monixidil? Or their own compound/topical as well?
There is a good chance they have added something which is already approved to the minoxidil (like azelaic acid for example), but their plan for the future is to use a WNT activator compound in clinic and that’s planned to be the real power punch. This will take trials though.
Why Peter why
How long can we expect the Pivotal/Phase 3 to take?
Plan on 6 months minimum.
Hurry? Please!…
Important to hedge expectations here. According to the FDA, approximately 25-30% of drugs move past Phase III trials. (https://www.fda.gov/patients/drug-development-process/step-3-clinical-research)
Joseph, I do understant that this is the final trial. Because its a medical device it may last only 6 months. The topical will be something already approved by the FDA.
In development is a superior topical but thats still many years away?!
Can you confirm my thoughts?
I guess the first ‘state of the art’ treatment will be NGF-574H from Celino, probably available to the general public towards the end of this year.
The next one should be Histogen in Mexico or China in 2020 (provided they did not abort the phase 3 trial in Mexico). No news from China what I find a bit strange!
After that probably Follica at the end of 2020.
I may be a bit optimistic here.
Anyway, I guess Celino is our best bet at the moment. Also ease of usage ie no traveling involved.
Greetings
M
MRKA it sounds like you are pretty spot on here. It appears that Celino’s product will reach the market by the end of the year. We’ll have to wait and see the results from it.
Follica does seem like it would be coming around late 2020.
Please do not get excited. There will be no treatment or cure in our lifetime. Big pharma wont allow it. They make too much money “treating” this condition.
This is actually not true, the people have a lot more to do with it than you think. For example HairClone tried to bring a significant treatment to market this year and the online crowd decided not to try out a crowdfunding campaign that was supposed to help them. You never know how well the treatment works until it’s trialed, but usually going for the trial is worth it.
Every “five years” companies come out with “treatments”
Cant blame people for choking on a crowdfunding campaign especially when it comes to hair loss treatments. Unfortunately we are all being taken for a ride but believe what you will. I as much as everyone am eager for a cure but it will be a long time away.
I’m not quite sure I understand your statement. HairClone put out a crowdfunding campaign to the general public of people with hair loss to fund their efforts to try and bring a treatment to the world (in UK) in 2019 and the people did not feel at the time that it was worth a try. In the long run we will find out if that was a good decision or not.
Did Hairclone ever detail this “treatment”? If they showed evidence of an effective treatment than surely people would have funded it to market. I don’t recall much explanation behind their treatment. Any idea if it is still in the works?
Yes, HairClone detailed their treatment many times and you can find probably 3 or 4 articles right on this site with explanations.
It’s still in the works but its delayed now because the public did not want to invest in it. I honestly thought that was odd.
Did you invest in their campaign?
I did
Joseph off topic, but do you think anybody is gonna fund RiverTown Therapeutics, as they have something that is incredibly impressive. I do not know why no big pharma company is not eager to buy it. It simply puzzles me ?.
Pharma companies can be strange sometimes yes. I’m with you on the puzzle thing, this industry tends to have a few puzzlers in it. One guess is the type of energy that people put into the industry from the online forum field.
Yeah, I hope someone someday will find a
good treatment .??
The reason people did not contribute to the crowdfunding is simple. They didn’t know about it.
I agree that the campaign could have used a better marketing approach, still there were a lot people online who saw it and decided to stand pat. Even every wealthy people who are very interested in cures. In all fairness, I thought it was an interesting response.
Device ? Are you serious ?
It’s pretty inconvenient way. Drugs is so much better way.
Joseph, I appreciate that you’re trying to be conscientious by replying to Bart’s “concerns”. I lump him in with the “no treatments will ever come”, “all people that use finasteride and minoxidil will get sides” “the drug companies are out to get us by withholding new treatments so they can sell more cheap, generic, unprofitable fin and min” and other various conspiracy theory trolls out there. A big reason why I don’t post on forums and rarely on blogs, despite being at this for over 35 years now.
Great to see your mind is open also Yoda and that you haven’t been brainwashed like most other people have.
Bart, look over your shoulder…I think someone is out to get you! Think positive Sonny, new treatments will come, no one can say which ones or when but they will surely come. Life is too short to live in a negative, paranoid state of mind.
I know new treatments will come , Never said they wouldn’t. But a real cure wont be in our lifetime.
Now that you guys have said your peace, let’s end it.
Hey Follicle Thought, recently you hinted that there is new company that may bring hair multiplication to the market without clinical trials?
Can you at least tell us when to expect more information?
You’ve been on fire recently, keep it up
Aclaris Therapeutics Announces Positive 6-Month Results from a Phase 2 Open-Label Clinical Trial of ATI-502 Topical in Patients with Androgenetic Alopecia (Male/Female Pattern-Baldness)
“The overall change was an increase of 8.6 hairs/cm2. TAHC increase was 15.3 hairs/cm2 in female subjects and 5.6 hairs/cm2 in male subjects.”
That’s really poor effect. And as far as it’s not a drug it’s so inconvenient to apply it.