A clinical trial, claimed to be ‘the most advanced topical JAK inhbitor trials’ in the USA for Alopecia Totalis and Alopecia Universalis – the two most severe phenotypes of Alopecia Areata, has reported positive initial results.
The interim data from this Phase 2, AA-202 Topical trial into an investigational Janus Kinase (JAK) inhibitor known as ATI-502, was announced by the development company Aclaris Therapeutics, on 28th June 2018.
Whilst the study was small – with only 11 participants – the reports so far are certainly encouraging given there are currently no consequential treatment options for these severe forms of autoimmune alopecia.
Positively impacts Alopecia Areata’s ‘genetic signature’
For a 28 day period ATI-502, the investigational topical Janus Kinase (JAK) 1/3 inhibitor or a placebo were given daily to 11 patients with either Alopecia Totalis – which causes baldness of the entire scalp and can also cause facial hairloss, including eyelashes and eyebrows – or Alopecia Universalis – which causes the head and body to become completely hairless. Following this, all patients were given ATI-502 as part of a six-month ‘open label’ period.
The primary aims were to evaluate ATI-502’s pharmacokinetics, pharmacodynamics and safety. How far into the skin the solution managed to penetrate was measured via punch biopsies taken at baseline and on day 28. This proved to be the same as in previous testing, with a mean absorption average of 5650 nanograms/gram at day 28.
Aclaris released information on the first six patients to be treated as part of this trial via a press release, which confirmed ‘no serious adverse events were reported during the 28-day dosing period’. It was noted that one patient did withdraw during the six-month open label period, however. This was reportedly the result of major depression unrelated to the clinical trial.
From the pharmacodynamic update provided, it appears the research team has made a potentially significant breakthrough regarding the biological processes that cause Alopecia Areata, as well as how to treat these most extreme phenotypes.
Of the six patients’ baseline interferon gamma and cytotoxic T-cell gene expression signatures, two showed high levels of elevation, two showed low levels of elevation and two showed no elevation at all. In each pair, one was treated wit ATI-502 and the other received a placebo. In each instance, there was a positive change in both biomarkers for the patient from each pair that was treated with the active drug.
According to Aclaris Therapeutics, Inc., ‘This data is the first indication that ATI-502 is absorbed through human skin in the clinical setting and engages the target. The results also demonstrate the pharmacodynamic effect of modulating the appropriate genes associated with the interferon gamma pathway and cytotoxic T-lymphocytes, which are 2 of 3 biomarker components of the Alopecia Areata Disease Activity Index (ALADIN) score.
Our hypothesis is this response can be predicted by a patient’s baseline genetic signature.’
Whilst there is still further testing to be done, and more clinical investigations are necessary, particularly on a wider scale, this does show that JAK inhibitor treatment for Alopecia Totalis and Universalis is definitely moving in the right direction.
Should all trials go to plan and the necessary medical regulatory licences and approvals, such as those from the UK’s MHRA and the FDA in America, it is estimated that these types of treatments should be ready for prescription around 2021. This would mean that people with these more severe variations could also have Alopecia Areata treatment options, as adults with the scalp-only form currently do.
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