Just as disappointing results were released by Aclaris Therapeutics for its lead Alopecia Areata treatment, Pfizer announced details of an up-coming Phase 3 clinical trial for its investigational drug known as PF-06651600.
This JAK inhibitor treatment will be studied on patients with all forms of the autoimmune disorder - Alopecia Areata (patchy hair loss of the scalp only), Alopecia Totalis (total baldness of the scalp and head, including facial hair, eyelashes and eyebrows) and Alopecia Universalis (losing all hair from head to toe).
Researchers will be assessing both the participants' health and hair count, using various methodology, at the beginning and end of the trial, with monitoring throughout.
The oral drug has been in development for the past few years and its progression to this latest stage of the clinical trial process has been eagerly awaited, not least because of the potential it may provide a hair loss solution for both adults and adolescents with Alopecia Areata of all kinds.
What is particularly encouraging about this study, which is due to commence on 22nd July 2019, is that the test subjects taking part are aged from 12 years old. It is also fairly substantial in size, with a total of 860 people being recruited to take part.
At present, whilst there are some hospital-based therapies that can be used for children with any phenotype, and adults with the more extensive iterations; examples include steroid scalp injections and immunotherapy.
At-home scalp-only Alopecia Areata Treatment tends to only be offered to those aged 16 years and over. This involves daily applications of a topical solution called high strength minoxidil which is clinically-proven to treat both Male and Female Pattern Hair Loss but, although not officially authorised for this purpose, has shown off-label potential for promoting hair growth in the case of other hair loss conditions, including scalp-only Alopecia Areata.
The Pfizer drug development and its clinical trials have been closely monitored and reviews of their data expedited by the American medical regulatory body, the FDA (the equivalent of the UK's MHRA).
This is due to Pfizer having received a Breakthrough Status designation in September 2018, essentially awarding a close relationships with the FDA and reviews of its findings to be fast-tracked.
The reason the FDA has become so closely involved in, not just this potential severe Alopecia Areata treatment, but others which have also been granted fast-track status, is due to the current unmet needs in this area.
Mental health issues have been repeatedly linked with the presence Alopecia Areata in all its forms, and as there is a real lack of safe and effective treatment options for patients with these autoimmune disorders - notably those with Alopecia Totalis, Universalis or those under 16 years of age with the milder form causing hair loss of the scalp.
As such, whilst counselling is often suggested to people with Alopecia Areata to help them learn how to cope with their condition, the FDA has sensibly taken the view that the sooner a safe, effective and tolerable - not to mention affordable - solution can be developed and authorised by the relevant medical regulators then made available to sufferers, the better.
This latest stage of the PF-06651600 trial is due to take a number of years, with findings due for release on 1st May 2023.
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