It's often the case that miraculous-sounding innovations claiming to cure
hair loss announce that they are starting clinical trials, never to be heard of again. This is certainly not the case when it comes to the area of janus kinase (JAK) inhibition.
Areas affected by hair loss shown in blue
The many on-going studies that have been investigating how to use this suite of drugs since it was shown they had potential applications for
Alopecia Areata hair regrowth, even in the most extensive cases of autoimmune baldness, have all continuously provided timely updates.
The latest of these comes from Concert Pharmaceuticals which announced the initial findings from the first two cohorts of its
Phase IIa trial of CTP-543 via press release on 12th November 2018.
Significant differences observed after 12 weeks
Top-line data from the latest Phase IIa stage of the clinical trial into the
oral drug CTP-543, as a potential treatment for moderate to severe forms of Alopecia Areata, the autoimmune disorder which causes baldness in hair-bearing areas, from rounded patchy hair loss of the scalp only (Alopecia Areata) to complete baldness of the head and from head to toe in cases of
Alopecia Totalis and Alopecia Universalis, respectively.
Whilst there are currently
Alopecia Areata treatment options for the scalp-only phenotype, the more extensive forms have limited options with generally low rates of success.
CTP-543 is a modified version of the JAK inhibitor
ruxolitinib, and these reports are taken from the findings after 24 weeks of study into 8mg per day doses versus a placebo.
When comparing patients' baseline hair growth levels (measured just before starting treatment) to those at Week 12 and Week 24, Concert reports that 'patients treated with an 8mg twice-daily dose of CTP-543 met the primary efficacy endpoint versus placebo (p <0.001). At this dose, significant differences from placebo were observed beginning at Week 12. Regrowth of hair did not appear to plateau at Week 24.'
More results to come
One of the concerns regarding the use of
JAK inhibitors as hair loss treatments has centred around potential side effects; whilst some pharmaceutical companies are opting to develop
topical versions to help minimise the chance of adverse reactions, Concert notes in this latest release its treatment was 'generally well tolerated'.
In September 2018 the company advised that it would be also be investigating the effect of 12mg/day doses; this arm of the trial is currently underway and we estimate top-line results will be made available by the end of January 2019.
Concert Pharmaceuticals was the first of three companies the American medical regulatory board, the FDA,
granted Fast Track status to, with regards its development of CTP-543. Due to the lack of FDA-approved treatment for Alopecia Areata, Totalis or Universalis, the government body is hoping to assist promising researchers to bring their treatments to market as soon as possible, by prioritising their reviews. It is currently believed that the first JAK inhibitor treatment for severe autoimmune alopecia is likely to be made available for prescription by 2021/22.