Will Pfizer Win the JAK Inhibitor Alopecia Areata Treatment Race?

Posted by Sarah

In this article: Hair Loss | Alopecia

Pharmaceutical titan Pfizer is the latest company to announce its hair loss news at the 2019 Annual Meeting of the American Academy of Dermatology in Washington DC, USA.

Promising results, showing what Dermatology Advisor describes as a 'rapid therapeutic effect', were provided from its randomised Phase 2a clinical trial into two separate treatment options for the autoimmune disorder Alopecia Areata, PF-06700841 and PF-06651600.

Both of these JAK inhibitors are designed to treat both patchy hair loss from moderate Alopecia Areata, through to the more extensive forms, Alopecia Totalis and Alopecia Universalis.

The new information was an update from earlier data released regarding these novel hair loss solutions at the EADV conference in September 2018.

race speed

With the FDA already monitoring this project and granting it 'breakthrough status', these new developments could signal that Pfizer may be winning the race to be the first to introduce FDA-approved and MHRA-licensed Alopecia Areata treatments based on JAK inhibitors. This is despite strong competition from the likes of Concert Pharmaceuticals which believes it may pip Pfizer to this particular post.

Full head of hair after 24 weeks

Pfizer's 24-week trial involved 142 patients, both male and female, aged between 18 and 75 years old. All participants had a professional diagnosis of moderate to severe autoimmune alopecia - either Alopecia Areata, Alopecia Totalis or Alopecia Universalis.

The volunteers were randomly assigned one of three separate treatments for the first four weeks - 48 were allocated 200 mg per day of PF-06651600, a tyrosine kinase 2 inhibitor (TYK2) and JAK1 inhibitor; 47 were given 60 mg per day of the janus kinase 3 (JAK3) inhibitor PF-06700841; 47 were administered a placebo.

This phase of the trial started with 4 weeks of treatment, followed by a 20-week maintenance period. During this maintenance stretch, the PF-06651600 candidates used a 50 mg daily dose, whilst the PF-06700841 group took 30 mg per day.

Both active medications reportedly started to show hair regrowth results at the 4 week (PF-06700841) and 6 week (PF-06651600) marks, based on changes to the participants' Severity of Alopecia Tool (SALT) scores from baseline.

Researchers noted that, within the PF-06700841 group, those who had been experiencing Alopecia Areata hair loss the longest (for 3.5 years or more, consecutively) had a slower response time of 8 weeks, compared to 4 weeks for those whose current episode had been going on for less than 3.5 years.

However, at the end of the 24-week trial, it was noted that all responders using either PF-06700841 or PF-06651600, had regrown a full head of hair.

Final results coming soon

The study completion date for this Phase 2a stage of the trial is currently registered as May 2019, so we could have the final findings within the next 10-12 weeks.

Once medications have successfully passed Phase III of the clinical trial process, and obtained the relevant authorisations from medical regulatory boards, such as the MHRA and FDA in the UK and USA respectively, they can then be released for prescription in those countries.

Although the scalp-only form tends to see hair regrowth occur naturally within 12 months of its onset in many cases, Alopecia Areata treatment is also available and with an often significant success rate, for this mild-to-moderate phenotype. A hair loss specialist can recommend appropriate solutions following a consultation, either in person or online, in these instances.

Further information and updates from this clinical trial and the numerous others currently underway in the hopes of developing the first JAK inhibitor-based Alopecia Areata treatment will be published here on the Belgravia hair loss blog. Details for this Pfizer trial can also be monitored via its official clinical trial documentation.

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The Belgravia Centre

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Posted by Sarah

In this article: Hair Loss | Alopecia

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