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FDA Says On Hold CTP-543 Alopecia Areata Clinical Trial Can Proceed


A trial into the use of a modified bone cancer drug as a possible treatment for people with the autoimmune disorder Alopecia Areata, which leads to sudden, patchy hair loss, has been green-lit to continue by America’s Food and Drug Administration.

The FDA had caused some concern among investors in US company Concert Pharmaceuticals when it put a temporary halt on a trial into its variation on the JAK inhibitor drug ruxolitinib as a possible treatment for Alopecia Areata. Ruxolitinib is also known by its current brand names Jakafi or Jakavi; it is currently prescribed in oral form for conditions such as myelofibrosis. It is being explored as a topical drug for Alopecia Areata after clinical trials in the USA discovered the topical formulation to be potentially more effective than an oral tablet.

Less than two months after the FDA-sanctioned halt was called, Massachusetts-based Concert has amended the scope of the trial into its orally-administered CTP-543 drug and been allowed to proceed.

food-and-drug-administration-usa-fdaDesign of trial modified

Roger Tung, Concert’s CEO, said: ““We believe the FDA is taking a measured approach for the development of Janus kinases inhibitors, or JAK inhibitors, for autoimmune dermatological disorders, including alopecia areata. Accordingly, we agreed to modify the design of our Phase IIa trial to evaluate CTP-543 in the patient population in a more step-wise fashion.”

Specifically, Concert has agreed to test low doses of the drug – 4mg and 8mg twice daily, or a placebo – before they will consider whether it is safe to increase it. Adds Tung: ‘It is important to note that CTP-543 has been well-tolerated in clinical evaluation to date and demonstrates a non-clinical safety profile consistent with JAK inhibition.”

The company plans on using a group of around 100 volunteers with patchy hairloss caused by Alopecia Areata for the double-blind trial. Though ruxolitinib itself has shown a great deal of promise as a possible future treatment option for the condition during its numerous clinical trials to date, Concert’s deuterated ruxolitinib drug may have the potential to offer patients a less-frequent dose regimen. This is because it has been engineered to have a longer half life than regular ruxolitinib, or, simply put, it should remain in the bloodstream for longer.

Drugs need to be proven

Studies into possible new treatments for the autoimmune disorder – which affects at least two per cent of all people in their lifetime – are ongoing at multiple locations around the world, though as all drugs need to be proven to be both safe and effective before they are cleared/licensed by the regulatory bodies of whichever countries they are intended for sale, it is a necessarily slow business.

At Belgravia, Alopecia Areata treatment is currently offered in the form of topical applications of the drug high strength minoxidil which has been seen to often produce highly effective results in regrowing hair on the scalp. Minoxidil is licensed by the MHRA for use on pattern hair loss in men and women, though it has also resulted in many success stories when used to treat Alopecia Areata.

Circ - Minoxidil iconThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.

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