Phase 2 Trial Progress: Follicum and Aclaris
Today, there have been updates from two companies with therapies in phase 2 clinical trials for AGA. Initially, I posted the Follicum news to the Updates page, then I later found that Aclaris had released news as well. This was compelling enough to create an article for these news items.
Follicum Trial Over 50% Enrolled
Follicum’s phase 2a trial for AGA has now enrolled over 50% of the 60 total patients who will be participating in the study. The trial subjects will receive injections of FOL-005, Follicum’s hair growth peptide. The trial is being carried out at two locations, the Clinical Research Center for Hair and Skin Science in Berlin, Germany and at Bioskin, in Hamburg, Germany. The phase 2a trial is designed to evaluate the hair growth response from different dosages of FOL-005. Patients will receive injections 3 times per week for 3 months total during the study. The study is expected to be completed in 2018.
From the official press release, CEO Jan Alenfall comments on a timetable for the trial results to be shared: “We are very pleased to note that the inclusion of patients proceeds according to plan and that patient recruitment has now reached halfway to the target. Our intention with the current clinical trial is to confirm recently documented results, where we saw both good effect and safety, as well as a very high patient response. We are looking forward to being able to present the results by the end of this year.”
Aclaris Phase 2 AGA Trial Underway
Also today, Aclaris Therapeutics announced that the first patient has been dosed in their phase 2 open-label study of ATI-502 in male and female androgenic alopecia. ATI-502 is a topical JAK inhibitor for JAK1 and JAK3. The trial will include 12 male and 12 female subjects who will receive topical applications of ATI-502 twice daily.
Dr. Stuart Shanler, Chief Scientific Officer of Aclaris, had this to say about the trial: “This trial is the first step in evaluating the potential clinical benefit of ATI-502 topical solution in treating patients with AGA, or male/female pattern baldness,This is an important step forward in understanding the clinical utility of our JAK inhibitors in patients with AGA.”
Calling this a “first step” seems accurate here, as we have previously discussed the fact that Aclaris seems to be developing a separate drug candidate, a “soft JAK inhibitor” for use in androgenic alopecia as well.
These news items are a positive and essential part of the process for new therapies to come to market. Until next time, Be well.
Posted in Aclaris Therapeutics, Follicum, Hair Growth Treatment
I realize this news is not extra flashy, yet it is still progress. Really, we should be thankful that these companies are able to get their programs to move forward.
I need something that works right now
Same here Oiluj
.. I’m reaching the end of my rope.
Hang in there buddy :), it’s still 2018
Hello. I just want to say thank you for your fantastic work on this web site.
Greetings from Portugal 🙂
Thank you very much Marta ?
How long is phase 2 usually ? What’s next usually? Like, what is generally the time schedules for these things? I’m quite a noob in medicine.
Thanks for reading and commenting Charlotte.
Well, phase 2s can take up to a year for full analysis, then 3-6 months to initiate a phase 3 if things are all set. However, it depends if the study is a phase 2a or 2b. Phase 2b is the last step before phase 3. In short, it is situational and does not have a “one size fits all” defined timeline.
FYI – I have seen comments from a blog reader stating that he was approached by the research company that was recruiting volunteers for the Aclaris trials. He said they were particularly interested in recruiting Norwood 3, 4 and 5. Which is obviously good news as they will be attempting to grow hair on completely bald areas.
Correct me if I’m wrong, but does that say “3 innections a week for 3 months”?
Besides the spelling of injections, you are correct.
I know what you mean, seems kind of a lot.
Is this Phase 2a or Phase 2b?
Both of these trials are phase 2a.
Ugh, curse these thumbs!!!! Lol
But yeah… That’s 32 injections.
I mean… If it were to fully reverse hair loss I’d be up to it….
If that didn’t also include the costs of airfaire and hotel stay as well…
Firstly i wanted to do the Trials Phase IIa with Follicle. Now I informed about the injected Protein “Osteopontin”. It is an Protein which is connected with cancer. In many different types of cancer the Osteopontin-Level is high. So I am very frustrated but I think that follicum could be very dangerous 🙁 ADMIN what do you think?
That would be a better question for Follicum, but I’m pretty sure they have done some research in that regard.