Aclaris Therapeutics, one of a handful of pharmaceutical companies at the forefront of developments regarding the use of janus kinase (JAK) inhibitor drugs to treat autoimmune-related hair loss
, has provided an end-of-year update for 2018.
The key talking points were its topical and oral JAK 1/3 inhibitors which were granted FDA Fast Track
status in July 2018 as part of the American medical regulatory board's bid to introduce its first approved treatment for all forms of Alopecia Areata
Areas affected by hair loss shown in blue
Alopecia Areata takes three main forms - patchy hair loss of the scalp only (Alopecia Areata), complete baldness of the scalp which can also be accompanied by loss of facial hair including eyebrows and eyelashes (Alopecia Totalis) and total hairless-ness, where the body rejects all hair from head to toe.
It is the third most common hair loss condition
worldwide behind Male and Female Pattern Baldness, and can affect men, women and children of all ages, races and hair types, though generally strikes before 40 years of age.
Whilst it is considered an autoimmune disorder, the precise cause is unknown in all forms of Alopecia Areata, though triggers
, including sudden shock and trauma, certain allergies and a genetic element have all been identified.
On-going Phase II clinical trials for topical JAK inhibitors
Two separate Phase 2 topical JAK inhibitor trials, of ATI-502
for the treatment of Alopecia Areata are currently underway, known by the reference codes AA-202 and AUATB-201.
The AA-202 Topical trial of ATI-502 is taking place in Australia and features 11 patients with Alopecia Totalis and Alopecia Universalis
Meanwhile in the USA, 12 patients with eyebrow hair loss as a result of Alopecia Areata, Totalis or Universalis, are having this specific area treated with AT1-502 in the AUATB-201 Topical trial.
A larger-scale, 129-patient randomised, double-blind, placebo-controlled study to assess the safety, efficacy and dosage responses of ATI-502 in cases of patchy, scalp-only Alopecia Areata was confirmed as fully enrolled in November 2018. Initial findings from this trial are due between April and June 2019.
Oral JAK inhibitor trial results expected late 2019
In December 2018 Aclaris advised patient enrolment had been completed for a separate trial - ref. AUAT-201 Oral - of an oral suspension of ATI-501.
This randomised, double-blind, parallel-group study will comprise 87 participants with Alopecia Areata, Totalis and Universalis.
Each will receive either ATI-501 in liquid form, or a placebo, with measurements noted in terms of hair regrowth changes between each individual's baseline and Week 24 score, using SALT readings (Severity of Alopecia Tool). This is the same evaluation methodology being used in both Aclaris' topical ATI-501 clinical trial assessments.
Initial AUAT-201 trial data regarding the safety, efficacy and dose response of three concentrations of ATI-501 is expected to be released between July and September 2019.
Updates on the latest developments in hair loss treatments for all these conditions, from Aclaris and the various others actively working in this sector, will be published on the Belgravia
blog as soon as new information becomes available.