Aclaris Therapeutics, ATI-50002

Aclaris Therapeutics Countdown Begins

47 Comments

As usual my plans to avoid talking about Aclaris for several months went down the tubes yet again (always a good thing). For those who are new to this blog, you can go to the “Categories” menu and select the “Aclaris Therapeutics” choice to read all my prior posts about the company. It is developing a unique topical JAK inhibitor product to treat androgenetic alopecia, the most common type of hair loss.

Aclaris Therapeutics Phase II Trials Commencing

Yesterday, blog reader “Champpy” made a highly interesting lengthy comment about the soon to start Aclaris Therapeutics Phase 2 clinical trials for their topical JAK inhibitor product named ATI-50002 (for treating male pattern hair loss). He was approached by a research company that is recruiting volunteers for the trials. The most important part of his comment was that they are especially interested in patients who are at least Norwood 3, 4, and 5 on the receding hairline scale. This caught my eye, because the implication is that the company expects ATI-50002 (if effective) to regrow hair even on entirely balding regions of the scalp.

Moreover, Aclaris also updated its clinical trials page yesterday with far more details (h/t “Tocatta”). While they mention that they are looking for 24 male and female participants, the research company that approached “Champpy” said that there was major interest from people interested in volunteering. I wonder if they can change their minds and recruit more than 24 people? Or maybe they are recruiting 24 people in each location that they mention on there (Colorado, Oregon and Texas) for a total of 72? The trials are expected to be completed at the end of October 2018.

Having mentioned all the above encouraging and speedy developments, it is still a good idea to keep things in perspective:

  1. There is a possibility that this topical JAK inhibitor treatment can cause serious side effects, including cancer. At the moment, this possibility looks to be rare to nonexistent, but it is too soon to tell for sure. Of course at the slightest sign of cancers or tumor growth, clinical trials will likely be disbanded immediately by the US FDA.
  2. Even on alopecia areata patients who often see tremendous hair regrowth with oral JAK inhibitors (e.g., see here and here), success rates have not been universal. Some patients see no regrowth at all, although at least half seem to get great results. So even if this treatment does end up working on those with androgenetic alopecia, it is likely that some people will never see any benefits.

I have mentioned this a number of times, but it is worth repeating: Aclaris is the first ever company involved in the search for a hair loss cure that has moved along faster than expected. In all other cases that I can remember from the past, companies involved in this sector have moved along far slower than expected, with numerous delays in trials and funding. Oftentimes, these companies have decided not to proceed with final stage clinical trials; or have sold rights to other companies; or have decided not to bring a product to the market even if it is somewhat effective at regrowing hair.

Hopefully Aclaris keeps surprising us and goes All The Way in this year of Shohei Ohtani.

Also, in March and April 2018, Aclaris CEO Neal Walker purchased almost 20,000 of his company’s shares.

Brotzu Lotion, Fidia Farmaceutici

Brotzu Lotion Countdown Begins

64 Comments

Update: April 15th 2018

— Dr. Brotzu’s entire presentation video is now available online. Keep in mind that this is not necessarily a summary from Fidia Farmaceutici itself. Hopefully, Fidia will update its website’s Brotzu lotion status later this year.

— The actual full presentation slides are available via the bellicapelli forums.

I first discussed the very interesting Brotzu lotion in early 2016. Since then, I have written several other posts in which I provided updates about the product, but all-in-all, there have been few major developments of note. Moreover, the product is supposedly not likely to benefit those who have lost most of their hair over five years ago. So its not a real cure for balding and hair loss, but nevertheless, a much needed potential alternative to existing hair loss medications Finasteride and Minoxidil.

The inventor of the product, Dr. Giovanni Brotzu, is now 83 years old. He is unlikely to make any further major breakthroughs at such an advanced age, although perhaps that is a moot point and the Brotzu lotion DGLA→PGE1 product is already as good as it can get for its particular chemistry.

Moreover, the patents for the Brotzu lotion and its potential future release are both in the hands of Fidia Farmaceutici (Italy) and not in the hands of the Brotzu family. The company last updated us in detail about the Brotzu lotion in January 2017 and concluded that:

We envisage the development of the potential product candidate being completed by 2018.

I am guessing that Fidia has its own researchers who are heavily involved with the product’s development, and Dr. Brotzu himself is now mostly an adviser.

Brotzu Lotion Status in 2018

Having said all that, the reason for this update is Dr. Giovanni Brotzu himself. Tomorrow, on April 14th, he is supposed to make an important presentation about his lotion at the Italian Society For Hair Science and Restoration’s annual conference. You can see a summary of this presentation on this page. When I translated the title, here is what came up:

Title of the Report: Liposomal solution containing DGLA, Equolo and Carnitene for the treatment of androgenetic alopecia.

If you live in Italy or are in the nearby vicinity, you can attend Dr. Brotzu’s lecture. More information after you scroll down in here. Questions will not be allowed.

  • There are a number of rumors online that the lotion could be released in the summer of 2018. I am skeptical that it can happen so fast, but that is probably why most people are so excited.
  • On Reddit Tressless, people have been going crazy about this since the beginning of this month. Eight of today’s top ten threads on there have the word “Brotzu” in their titles! Complete insanity.
  • Zero of the top ten threads on Reddit Tressless have the word “Aclaris” in their titles.  See my next blog post from later today for more on that.
  • Also make sure to follow the original still growing Italian forum thread on this subject as well as the gigantic HLT forum thread on this subject.

A Hair Loss Cure News Blog