Changes Made to Phase 2a CTP-543 Alopecia Areata Treatment Trial
One of the hair loss world's most hotly anticipated clinical trial results report concerns Concert Pharmaceuticals' CTP-543 drug.
This novel solution is being tested as a potential treatment for even the most severe forms of the autoimmune disorder Alopecia Areata which can cause anything from bald spots and rounded patches anywhere on the scalp, to complete baldness from head to toe.
Currently in the Phase 2a stage of the clinical trial process, the pharmaceutical company has announced it is amending its initial remit, expanding it to include an additional set of tests.
It was announced in August 2018 that 4mg and 8mg doses of CTP-543 would be trialled during the 12-week Phase 2a research, however, in late September 2018 an additional cohort of 12mg was introduced.
According to a press release issued by Concert Pharmaceuticals, "In the third quarter of 2018, an independent Data Monitoring Committee (DMC) conducted a planned interim safety data review after patients in the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice daily for at least 12 weeks. Based on this review, the DMC provided its recommendation to continue with the current 8 mg cohort to completion and also provided support for an additional cohort to evaluate the 12 mg dose twice daily. The Company has initiated enrollment in the 12 mg cohort. The Company also expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in the fourth quarter of 2018."
CTP-543 is an oral JAK inhibitor drug which was developed from ruxolitinib - a prescription medication currently available for the treatment of moderate to high risk myelofibrosis under the brand name of Jakafi.
It is one of three Alopecia Areata treatment drugs currently in development that have been awarded expedience by the Food and Drug Administration (FDA) in the USA. Concert was awarded FDA Fast Track status in January 2018 for CTP-543.
Mild to moderate Alopecia Areata of the scalp only can be notably different to the more extensive forms, Alopecia Totalis and Alopecia Universalis, which cause total hairloss of the head, and head and body, respectively.
Alopecia Areata which appears as patchy hair loss on the scalp will often see spontaneous recovery with hair regrowth resuming naturally within 12 months in many cases. This is not often so for the more extreme phenotypes.
Alopecia Areata treatment for the scalp only form can involve topical medications to help accelerate hair growth and can often be carried out at home. In contrast, Alopecia Totalis and Alopecia Universalis treatment options tend to be hospital-based and currently mostly revolve around steroid injections or topical immunotherapy sessions, and the success rates tend to be on the low side.
It is for this reason that the FDA is encouraging promising treatments particularly those aimed at these more pervasive by helping to expedite their development by prioritising their reviews by the medical regulatory body. It is currently hoped that the first FDA approved treatments may be available by 2021.
This novel solution is being tested as a potential treatment for even the most severe forms of the autoimmune disorder Alopecia Areata which can cause anything from bald spots and rounded patches anywhere on the scalp, to complete baldness from head to toe.
Currently in the Phase 2a stage of the clinical trial process, the pharmaceutical company has announced it is amending its initial remit, expanding it to include an additional set of tests.
Now also evaluating higher doses of CTP-543
It was announced in August 2018 that 4mg and 8mg doses of CTP-543 would be trialled during the 12-week Phase 2a research, however, in late September 2018 an additional cohort of 12mg was introduced.
According to a press release issued by Concert Pharmaceuticals, "In the third quarter of 2018, an independent Data Monitoring Committee (DMC) conducted a planned interim safety data review after patients in the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice daily for at least 12 weeks. Based on this review, the DMC provided its recommendation to continue with the current 8 mg cohort to completion and also provided support for an additional cohort to evaluate the 12 mg dose twice daily. The Company has initiated enrollment in the 12 mg cohort. The Company also expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in the fourth quarter of 2018."
CTP-543 is an oral JAK inhibitor drug which was developed from ruxolitinib - a prescription medication currently available for the treatment of moderate to high risk myelofibrosis under the brand name of Jakafi.
It is one of three Alopecia Areata treatment drugs currently in development that have been awarded expedience by the Food and Drug Administration (FDA) in the USA. Concert was awarded FDA Fast Track status in January 2018 for CTP-543.
Current Alopecia Areata treatment options
Mild to moderate Alopecia Areata of the scalp only can be notably different to the more extensive forms, Alopecia Totalis and Alopecia Universalis, which cause total hairloss of the head, and head and body, respectively.
Alopecia Areata which appears as patchy hair loss on the scalp will often see spontaneous recovery with hair regrowth resuming naturally within 12 months in many cases. This is not often so for the more extreme phenotypes.
Alopecia Areata treatment for the scalp only form can involve topical medications to help accelerate hair growth and can often be carried out at home. In contrast, Alopecia Totalis and Alopecia Universalis treatment options tend to be hospital-based and currently mostly revolve around steroid injections or topical immunotherapy sessions, and the success rates tend to be on the low side.
It is for this reason that the FDA is encouraging promising treatments particularly those aimed at these more pervasive by helping to expedite their development by prioritising their reviews by the medical regulatory body. It is currently hoped that the first FDA approved treatments may be available by 2021.
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.
View our Hair Loss Success Stories, which includes the world's largest gallery of hair growth photos and demonstrates the level of success that so many of Belgravia's patients achieve.
