2018 Timeline Update for CTP-543 Alopecia Areata Treatment
Concert Pharmaceuticals has announced an outline of its timeline for key products currently in its development pipeline, for the rest of 2018.
One of these is the drug CTP-543 - a potential treatment for all forms of Alopecia Areata, the autoimmune disorder which causes varying degrees of sudden hair loss from hair bearing areas of the scalp and body.
This, along with JAK inhibitors, currently being developed by New York's Columbia University and licensed exclusively to Aclaris Therapeutics, has been among the most hotly anticipated innovations with regards the treatment of autoimmune alopecia in recent years.
January 2018 saw CTP-543 being fast-tracked for development by the Food & Drug Administration (FDA) in America, due to there being significant 'unmet needs' in this area. Although Alopecia Areata treatment is possible for the scalp only form - considered the mildest - the most severe forms of Alopecia Areata - Alopecia Totalis and Alopecia Universalis - cannot currently be treated. These cause baldness of the head and from head to toe, respectively. Additionally, there are no MHRA licensed or FDA approved treatments for any of these conditions.
According to a press release issued by Concert as part of a shareholder update, the following CTP-543 milestones have been scheduled for the fourth quarter of 2018 (between October and December) in relation to the treatment of 'moderate-to-severe alopecia areata':
- At 12 weeks in, a planned safety data review of the Phase 2a double-blind, randomized, placebo-controlled, sequential dose trials investigating the safety and efficacy of 4mg and 8mg taken twice daily, will be conducted by an independent Data Monitoring Committee (DMC)
- If the DMC's outcome of the planned safety data review is positive, Concert will look to add in an additional arm to the trial, testing a 12mg CTP-543 dose twice daily, to be evaluated in comparison to a placebo
- Release of Phase 2a topline data from this trial into 4 mg and 8 mg CTP-543 taken twice daily.
President and Chief Executive Officer of the Massachusetts-based company, Roger D. Tung, PhD - pictured - explained, “Our focus in the first half of this year has been to execute on advancing our proprietary pipeline candidates to key clinical inflection points. The Phase 2 trial evaluating the 4 and 8 mg twice daily cohorts of CTP-543 for alopecia areata is on track for clinical completion later this year with a topline data readout in the fourth quarter.
In addition, our team is poised to move our next candidate, CTP-692 for schizophrenia, into Phase 1 evaluation by year-end. Importantly, both of these candidates are expected to advance in Phase 2 trials in 2019 in support of their respective registration programs.”
As there are three Phases that novel drugs need to successfully complete before seeking the necessary medical regulatory board approvals, it would appear the CTP-543 timeline is similar to that estimated for Aclaris' JAK inhibitor treatment release - currently by 2021. This also applies to existing medications being used in new ways other than those they are currently cleared for. For instance, existing JAK inhibitors such as tofacitinib - which has FDA and European Medicines Agency (EMA) approvals, though is not MHRA licensed, for the treatment of ulcerative colitis - will need to undergo fresh clinical trials in order to prove its safety, efficacy and tolerability as a treatment for Alopecia Areata before these agencies will consider granting the necessary documentation for this new use.
CTP-543 is actually based on the Janus Kinase (JAK) inhibitor tofacitinib; it is what's known as a deuterium-moderated analogue form of this drug. This essentially means creating new, deuterated forms of previously studied compounds - in this case, tofacitinib - in order to improve a drug's clinical safety, tolerability and/or efficacy.
If all goes to plan, 2021 could be an extremely exciting time in the hairloss industry with people whose autoimmune-related baldness finally having realistic hair regrowth options. We eagerly await news of developments in this area - including details of pricing and any proposed age restrictions - and will report them here on the Alopecia section of Belgravia's dedicated hair loss blog as soon as updated information becomes available.
One of these is the drug CTP-543 - a potential treatment for all forms of Alopecia Areata, the autoimmune disorder which causes varying degrees of sudden hair loss from hair bearing areas of the scalp and body.
This, along with JAK inhibitors, currently being developed by New York's Columbia University and licensed exclusively to Aclaris Therapeutics, has been among the most hotly anticipated innovations with regards the treatment of autoimmune alopecia in recent years.
CTP-543 Alopecia Areata treatment development timeline
January 2018 saw CTP-543 being fast-tracked for development by the Food & Drug Administration (FDA) in America, due to there being significant 'unmet needs' in this area. Although Alopecia Areata treatment is possible for the scalp only form - considered the mildest - the most severe forms of Alopecia Areata - Alopecia Totalis and Alopecia Universalis - cannot currently be treated. These cause baldness of the head and from head to toe, respectively. Additionally, there are no MHRA licensed or FDA approved treatments for any of these conditions.
According to a press release issued by Concert as part of a shareholder update, the following CTP-543 milestones have been scheduled for the fourth quarter of 2018 (between October and December) in relation to the treatment of 'moderate-to-severe alopecia areata':
- At 12 weeks in, a planned safety data review of the Phase 2a double-blind, randomized, placebo-controlled, sequential dose trials investigating the safety and efficacy of 4mg and 8mg taken twice daily, will be conducted by an independent Data Monitoring Committee (DMC)
- If the DMC's outcome of the planned safety data review is positive, Concert will look to add in an additional arm to the trial, testing a 12mg CTP-543 dose twice daily, to be evaluated in comparison to a placebo
- Release of Phase 2a topline data from this trial into 4 mg and 8 mg CTP-543 taken twice daily.
President and Chief Executive Officer of the Massachusetts-based company, Roger D. Tung, PhD - pictured - explained, “Our focus in the first half of this year has been to execute on advancing our proprietary pipeline candidates to key clinical inflection points. The Phase 2 trial evaluating the 4 and 8 mg twice daily cohorts of CTP-543 for alopecia areata is on track for clinical completion later this year with a topline data readout in the fourth quarter.
In addition, our team is poised to move our next candidate, CTP-692 for schizophrenia, into Phase 1 evaluation by year-end. Importantly, both of these candidates are expected to advance in Phase 2 trials in 2019 in support of their respective registration programs.”
Autoimmune baldness treatment by 2021?
As there are three Phases that novel drugs need to successfully complete before seeking the necessary medical regulatory board approvals, it would appear the CTP-543 timeline is similar to that estimated for Aclaris' JAK inhibitor treatment release - currently by 2021. This also applies to existing medications being used in new ways other than those they are currently cleared for. For instance, existing JAK inhibitors such as tofacitinib - which has FDA and European Medicines Agency (EMA) approvals, though is not MHRA licensed, for the treatment of ulcerative colitis - will need to undergo fresh clinical trials in order to prove its safety, efficacy and tolerability as a treatment for Alopecia Areata before these agencies will consider granting the necessary documentation for this new use.
CTP-543 is actually based on the Janus Kinase (JAK) inhibitor tofacitinib; it is what's known as a deuterium-moderated analogue form of this drug. This essentially means creating new, deuterated forms of previously studied compounds - in this case, tofacitinib - in order to improve a drug's clinical safety, tolerability and/or efficacy.
If all goes to plan, 2021 could be an extremely exciting time in the hairloss industry with people whose autoimmune-related baldness finally having realistic hair regrowth options. We eagerly await news of developments in this area - including details of pricing and any proposed age restrictions - and will report them here on the Alopecia section of Belgravia's dedicated hair loss blog as soon as updated information becomes available.
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