Oral Alopecia Areata JAK Inhibitor Treatment Fast-Tracked by FDA
The race to release the first clinically-proven treatment for autoimmune hair loss started hotting up throughout 2017. Now, less than two weeks into the start of 2018, a possible front-runner has emerged in the form of Concert Pharmaceuticals' drug, CTP-543.
Having previously had its phase 2 clinical trial put on hold due to safety concerns, this oral Janus kinase (JAK) inhibitor has now been granteed Fast Track approval by the American medical regulatory body, the FDA, for the treatment of moderate-to-severe forms of alopecia areata.
In all cases of alopecia areata the precise cause is unknown, though it is understood that a trigger - for instance sudden shock or trauma, or allergies - cause the immune system to turn on the hair follicles. This results in the hair growth cycle getting stuck in its resting (Telogen) phase, so that hair falls out but is not replaced by new hair. This can cause a pause that is temporary or permanent but, unfortunately due to the highly unpredictable nature of alopecia areata, if or when hair regrowth will occur cannot be predicted.
There are already effective alopecia areata treatment courses available for the scalp-only form of this autoimmune disorder - also known as alopecia areata - which causes sudden, patchy hair loss. This often leaves behind rounded bald patches - often more than one although a single bald spot is also possible - which can vary in size from that of a £2 coin to far larger.
At Belgravia this involves the use of topical applications of high strength minoxidil from the formulations available at our in-clinic pharmacies, used directly on the affected areas in order to encourage hair growth. This treatment has been approved by both the MHRA and the FDA for the treatment of male and female pattern baldness, and - whilst not approved specifically for alopecia areata treatment - its efficacy in treating other hair loss conditions is widely acknowledged by specialists in this area.
This latest development is of particular interest as there are currently no effective or proven, treatments for Alopecia Totalis and Alopecia Universalis. These are the most severe forms of alopecia areata and cause baldness of the entire head, including facial hair, eyebrows and eyelashes, in cases of Alopecia Totalis, and complete hairloss from head to toe in cases of Alopecia Universalis.
Concert's CTP-543 aims to treat both these extreme forms of the hair loss-causing autoimmune disorder. The pharmaceutical company explains that it is for this reason - 'to facilitate the development and expedite the review of new therapies to treat serious conditions and address unmet medical needs' - that the FDA has granted the project Fast Track status.
According to the latest information released by Concert Pharmaceuticals in a press release dated 12th January 2018, the development of CTP-543 in tablet form will now be expedited in collaboration with the FDA. This means that the FDA will prioritise its responses to and reviews of the drug trial queries and findings.
“Fast Track designation recognizes that alopecia areata is a serious disease in need of effective treatments. We look forward to collaborating with the FDA on the development of CTP-543,” said James Cassella, Ph.D., Concert's Chief Development Officer. “There are no FDA-approved treatments for alopecia areata and CTP-543 would represent a significant medical advance as a potential first-in-class treatment for moderate-to-severe disease.”
The drug is part of a suite known as JAK inhibitors which were initially discovered to have hair regrowth benefits in cases of alopecia universalis by the medical division of Columbia University in New York. They are also developing a range of oral and topical JAK inhibitors to treat various hair loss conditions, including moderate to severe alopecia areata and androgenetic alopecia. Columbia researchers are working in conjunction with Aclaris Therapeutics, to whom the trustees have exclusively licensed their portfolio of JAK inhibitor drug patents, the first of which has an anticipated release date of 2020/2021.
CTP-543 is currently conducting a double-blind, randomized, placebo-controlled Phase 2a trial across a number of locations. These trials aim to evaluate the safety and efficacy of CTP-543 when used to treat adults with all forms of alopecia areata. A phase 2 trial is the penultimate stage of clinical testing before a drug is sent for medical board approval, following which it may be released for use.
Having previously had its phase 2 clinical trial put on hold due to safety concerns, this oral Janus kinase (JAK) inhibitor has now been granteed Fast Track approval by the American medical regulatory body, the FDA, for the treatment of moderate-to-severe forms of alopecia areata.
Treatment for severe alopecia areata
There are already effective alopecia areata treatment courses available for the scalp-only form of this autoimmune disorder - also known as alopecia areata - which causes sudden, patchy hair loss. This often leaves behind rounded bald patches - often more than one although a single bald spot is also possible - which can vary in size from that of a £2 coin to far larger.
At Belgravia this involves the use of topical applications of high strength minoxidil from the formulations available at our in-clinic pharmacies, used directly on the affected areas in order to encourage hair growth. This treatment has been approved by both the MHRA and the FDA for the treatment of male and female pattern baldness, and - whilst not approved specifically for alopecia areata treatment - its efficacy in treating other hair loss conditions is widely acknowledged by specialists in this area.
This latest development is of particular interest as there are currently no effective or proven, treatments for Alopecia Totalis and Alopecia Universalis. These are the most severe forms of alopecia areata and cause baldness of the entire head, including facial hair, eyebrows and eyelashes, in cases of Alopecia Totalis, and complete hairloss from head to toe in cases of Alopecia Universalis.
Concert's CTP-543 aims to treat both these extreme forms of the hair loss-causing autoimmune disorder. The pharmaceutical company explains that it is for this reason - 'to facilitate the development and expedite the review of new therapies to treat serious conditions and address unmet medical needs' - that the FDA has granted the project Fast Track status.
Currently in clinical trial testing
“Fast Track designation recognizes that alopecia areata is a serious disease in need of effective treatments. We look forward to collaborating with the FDA on the development of CTP-543,” said James Cassella, Ph.D., Concert's Chief Development Officer. “There are no FDA-approved treatments for alopecia areata and CTP-543 would represent a significant medical advance as a potential first-in-class treatment for moderate-to-severe disease.”
The drug is part of a suite known as JAK inhibitors which were initially discovered to have hair regrowth benefits in cases of alopecia universalis by the medical division of Columbia University in New York. They are also developing a range of oral and topical JAK inhibitors to treat various hair loss conditions, including moderate to severe alopecia areata and androgenetic alopecia. Columbia researchers are working in conjunction with Aclaris Therapeutics, to whom the trustees have exclusively licensed their portfolio of JAK inhibitor drug patents, the first of which has an anticipated release date of 2020/2021.
CTP-543 is currently conducting a double-blind, randomized, placebo-controlled Phase 2a trial across a number of locations. These trials aim to evaluate the safety and efficacy of CTP-543 when used to treat adults with all forms of alopecia areata. A phase 2 trial is the penultimate stage of clinical testing before a drug is sent for medical board approval, following which it may be released for use.
The Belgravia Centre
The Belgravia Centre is a world-renowned group of a hair loss clinic in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation from anywhere in the world for home-use treatment.
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