Latter Phases of Pfizer Alopecia Areata Treatment Trials Begin

As the new year begins, it seems we are getting increasingly closer to the possibility of even the most severe cases of Alopecia Areata becoming treatable.

On 4th January 2019, pharmaceutical titan Pfizer announced the start of its phase 2b/3 trials into its potential Alopecia Areata treatment, PF-06651600.

Developing PF-06651600 for advanced Alopecia Areata phenotypes

This novel drug is an oral JAK inhibitor designed to treat Alopecia Areata from moderate patchy hair loss, through to Alopecia Totalis and Alopecia Universalis which cause total baldness of the head, and from head-to-toe, respectively. All of these types of hair loss are considered autoimmune disorders and hair fall occurs when the condition is triggered and the body starts to attack its own follicles resulting in sudden shedding.

At present, Alopecia Areata treatment is generally only possible for adults where it appears in the mildest form, whereby rounded bald spots and patches of hair loss occur to the scalp only.

Pfizer's PF-06651600 received special FDA 'Breakthrough Therapy' designation in September 2018, potentially allowing its development to be fast-track by the American Food and Drug Administration body. It is hoped the drug trials - which involve 660 participants from 12 years of age and over with at least 50 per cent hair loss from any form of Alopecia Areata - will build upon its earlier results from previous phases.

These showed that orally administered doses of PF-0665160 improved hair regrowth within 24 weeks and was generally well-tolerated.

You can read more about how these latest trial phases will be conducted, here.

Competitive race is closing in

It is the goal of many medical professionals and companies to develop the first safe, tolerable and effective form of treatment for the more extensive Alopecia Areata phenotypes, to be authorised by the relevant medical regulatory boards, such as the MHRA and FDA.

These highly visible conditions can be emotionally distressing and psychologically traumatic for the sufferer, especially as they can come on so quickly. Therefore, finding a suitable hair loss solution has been deemed a priority by the FDA.

Whilst various clinical trials are on-going in this respect, Pfizer's announcement shows that it may be the closest to completion. Phase 3 is the last stage of clinical trial testing before a drug is assessed for the relevant authorisations and release via prescription.

There are currently two other organisations whose novel Alopecia Areata treatments - some oral, some topical - were granted FDA 'Fast Track' status in 2018, with the estimated date these companies are aiming to make their medications ready for prescription (assuming relevant MHRA licenses in the UK and FDA approval in the USA are granted), understood to be 2021/2022.