Update from ATI-502 Topical Pattern Hair Loss Treatment Trial

Aclaris Therapeutics has announced the six-month findings from its Phase 2 open-label clinical trial into ATI-502 - a topical hair loss solution being tested as a potential treatment for Male Pattern Baldness and Female Pattern Hair Loss.

The physician-led biopharma released its latest update on this investigational JAK inhibitor drug in a press release dated 17th June 2019. It noted that this data is from the trial's mid-point, with 12-month findings due in the next six months, by the end of 2019.

ATI-502 is one of the company's leading hopes and is currently being fast-tracked by the FDA for use as a potential treatment for autoimmune hair loss caused by Alopecia Areata, Alopecia Totalis and Alopecia Universalis.

Women's hair loss improved the most

This six month update advised the trial has so far been evaluating men and women aged between 18 and 50 years old, with genetic hair loss.

Each of the 23 participants who completed the full six months applied topical ATI-502 to their scalp twice per day for 26 weeks. The precise dosages were not revealed.

Of these 23 test subjects, 20 (14 of whom were male, 6 of whom were female) had "evaluable hair counts", and 22 of them (15 male, 7 female) recorded investigator global assessment (IGA) and subject self-assessment (SSA) scores.

The mid-point data showed an overall hair count increase of 8.6 hairs/cm2 (non-vellus) at the six month mark. Whilst the male participants showed an overall increase of 5.6 hairs/cm2, the women saw almost three times that, with an overall increase recorded as 15.3 hairs/cm2.

Results from the IGA and SSA components involved subjects with positive hair growth increases being allocated a score of 1 for a slight increase, 2 for a moderate increase, or 3 for greatly increased hair growth.

Aclaris say investigators rated 73% of the participants (16/22) as "experiencing increased hair growth", however, 82% (18/22) of the test subjects self-assessed themselves as such.

ATI-502 was found to be well-tolerated in this small-scale study as no treatment-related serious adverse events were recorded. One unrelated incidence of breast cancer was reported in week one and the affected patient withdrew immediately.

Subsequent trial may be female-focussed

According to Dr. Neal Walker, President and Chief Executive Officer of Aclaris, “This finding demonstrates that inhibiting a non-hormonal and inflammatory-mediated pathway may be an option for the treatment of AGA [Androgenetic Alopecia - male and female pattern hairloss].”

Further to this, Aclaris also advised that through recent formulation work, it "can achieve significantly higher topical concentrations of ATI-502".

As such, Aclaris have advised that its next steps will involve initiating a double-blind, randomized, controlled Phase 2 dose-ranging clinical trial with higher concentrations of ATI-502.

It was also indicated that this trial, due to start in the first half of 2020, may potentially have a "female focus".

Should ATI-502 make it through the relevant stages of development and be able to finally demonstrate sufficient safety, efficacy and tolerability that it is awarded the relevant licences and approvals from medical regulatory boards, such as the MHRA and FDA in the UK and USA, it will be the first significant breakthrough in this area in decades.

Currently the only MHRA-licensed and FDA-approved hair loss treatments for men and women are high strength minoxidil - a unisex topical hair loss solution - and finasteride 1mg - a one-a-day oral DHT-blocker for use by medically-suitable men only.

These clinically-proven treatments are already widely-used either on their own or in combination with hair growth supporting products such as low level laser therapy devices and highly-targeted food supplements such as Hair Vitalics, by both women looking to regrow their thinning hair and men hoping to prevent baldness.