Aclaris Announces 'Disappointing' Alopecia Areata Trial Results

When it comes to developing potential JAK inhibitor hair loss treatments for Alopecia Areata, Aclaris Therapeutics Inc. has been one of the key players.

The company's status in this field has largely come about thanks to various exclusive JAK inhibitor licenses and patents granted through partnerships with the Trustees of Columbia University.

Researchers at the university's prestigious medical school were among the first to discover the potential of Janus kinase inhibitors to treat autoimmune hair loss, from scalp-only Alopecia Areata to the most extensive phenotype, Alopecia Universalis which causes complete baldness from head-to-toe.

It is currently investigating a novel, topical hair loss solution known as ATI-502 for this purpose, which was granted FDA Fast Track designation.

While the regular clinical trial results the company has shared so far have generally seemed promising, the Aclaris share price dropped sharply on Thursday 27th June 2019 after the latest update from its mid-stage trial was less than stellar.

According to a report on the 24/7 Wall Street website, the future of the study may now be in jeopardy, despite the company's stated dedication to exploring JAK inhibition to find a viable, safe and effective way to treat autoimmune hair loss.

Results from Phase 2 trial "disappointing"

It was announced that the Phase 2 clinical trial of ATI-502 did not achieve statistical superiority in its hair growth at week 24 remit; additionally, high rates of disease resolution were noted following treatment in those using ATI-502.

Both investigator relating to hair counts and hair density measurements, and patient-reported data as to satisfaction, failed to produce statistically significant results, although the drug - which is applied directly to the skin - was generally found to be tolerable.

"We are surprised and extremely disappointed by the results of this Phase 2 trial. This is disappointing not only for the company, but also for patients who are living with alopecia areata," said Aclaris president and CEO, Dr. Neal Walker. "We sincerely thank the patients and investigators who participated in this trial. We look forward to advancing our other development programs."

Although this sign off does not sound positive, it is not a decisive confirmation of the trial's cancellation and we will report on updates as to the trial's status as we receive them. In the meantime, other pharmaceutical companies, including Pfizer and Concert, continue to develop different JAK inhibitors as future Alopecia Areata, Totalis and Universalis treatments.

JAK inhibitor treatments may be too expensive

This news comes at a time when speculation has become rife online as to whether JAK inhibitor-based Alopecia Areata treatments may be prohibitively expensive for many potential patients.

Concerns voiced in online forums - and respected medical journal The Lancet - refer not only to how expensive JAK inhibitor treatments are likely to be should they get the necessary medical board licenses and clearances to become available for prescription, but also to whether they would even be offered on the NHS in the UK, or be covered by medical insurance.

Given many, somewhat controversially, consider hair loss - even in the case of autoimmune disorders such as Alopecia Areata - to be a 'cosmetic' problem, there is some doubt over whether medical insurance companies would cover its use.

As the negative associations between Alopecia Areata and mental health become increasingly apparent, this is hopefully an issue that can be resolved in time for the potential release of any new Alopecia Areata treatments, which could be as early as 2021.

For now, those with the scalp-only phenotype presenting as sudden hair loss and bald spots or rounded bald patches have the option of using topical Alopecia Areata treatment, whilst - although with a lower success rate - steroid injections and immunotherapy are sometimes offered to patients with Alopecia Totalis or Universalis to help promote hair regrowth.

Children with any iteration or over 16s with Alopecia Totalis or Universalis should consult their GP as the first port of call, whilst those whose hair loss is confined to just the scalp may seek the advice of a hair loss specialist for diagnosis and treatment recommendations.