Aclaris Terminates ATI-502 Alopecia Areata Treatment Development

On 12th September 2019 it was made official that Aclaris Therapeutics Inc has dropped out of the race to develop the first JAK inhibitor-based treatment for all forms of Alopecia Areata.

The company's official clinical trial registration for the open label study of its novel topical and oral hair loss solution, known as ATI-502, was updated with the news that it has decided to end its investigations.

This follows disappointing performance reports after ATI-502 Phase 2 trials for each iteration of autoimmune alopecia, from the mild scalp-only form, through to the more extensive Alopecia Totalis and Alopecia Universalis.

Portfolio of exclusive patents

Aclaris has been developing these janus kinase inhibition-based drugs since around 2016, when they announced a 'strong commitment' to this particular approach.

The company worked closely with Columbia University in America, which made some of the initial discoveries relating to how JAK inhibitors can be used to treat Alopecia Areata, and acquired many exclusive patent rights to a number of different members of this suite of drugs, licensed from both the Columbia Trustees and others.

What will happen to this impressive portfolio of patents remains to be seen.

Although the company also explored ATI-502 for the treatment of Male Pattern Baldness and Female Pattern Hair Loss, and developed a separate ATI-501 oral candidate for Alopecia Areata, its website suggests these also stalled at the Phase 2 stage.

Pfizer and Concert Pharmaceuticals battling it out

With Aclaris now out of the picture, and the race to bring the first ever Alopecia Areata, Totalis and Universalis treatment to market that is FDA-licensed (and hopefully MHRA-approved, the MHRA being the UK equivalent of the FDA - America's medical regulatory board) reaching its latter stages, two clear competitors have emerged.

Pfizer and Concert Pharmaceuticals are now the two leading pharmaceutical companies left with hats in this particular hair loss ring, and both have promising-looking propositions.

Pfizer is currently in Phase 3 trials for JAK inhibitor treatments for both adults and adolescents, from 12 years of age, with all forms of Alopecia, whilst Concert is preparing to enter the Phase 3 stage, having recently announced positive findings from its Phase 2 trials of over 18s.

The FDA is working closely with both companies, having awarded Concert Pharmaceuticals Fast Track status for its CTP-543 candidate, and granted Pfizer Breakthrough status for its PF-06651600 drug.

There are currently no officially recognised treatments for this condition and, whilst the scalp-only form has both Alopecia Areata treatment course options and tends to right itself naturally within up to 12 months, Alopecia Totalis and Universalis in adults and all forms in children have little in the way of safe and effective therapies available - yet.