Tandem approach??
Comcert Pharmaceuticals Announced Phase 2 Dose‑Ranging Clinical Trial Results of CTP‑543 in Patients with Alopecia Areata published in the Journal of the American Academy of Dermatology
7:08 am ET June 7, 2022 (Benzinga) Print
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the publication of safety and efficacy data from the randomized, double-blind, placebo-controlled dose-ranging Phase 2 clinical trial for CTP‑543 in the Journal of the American Academy of Dermatology (JAAD). CTP-543 is an investigational oral Janus Kinase (JAK) inhibitor being evaluated in ongoing clinical trials for the treatment of adults with moderate to severe alopecia areata, an autoimmune disease in which the immune system attacks hair follicles and results in hair loss. The publication reports clinically meaningful and statistically significant scalp hair regrowth after 24 weeks of treatment with CTP-543 in both the 8 mg twice-daily and 12 mg twice-daily dose groups in patients with alopecia areata.
"We have made so much progress in alopecia areata in so short a time, and it is utterly exciting to see JAK inhibitors advance as a potential treatment for alopecia areata," said Brett King, M.D., Department of Dermatology, Yale University School of Medicine and lead author of the publication. "The therapeutic response in patients as early as 12 weeks in this trial is significant, and we hope that with continued development CTP-543 will become a treatment option for the many people suffering from this serious autoimmune disease."
The publication highlights the establishment of two doses of CTP-543 with statistically significant hair regrowth and a generally well tolerated safety profile in patients with moderate to severe alopecia areata. Additionally, patient-reported outcomes of improvement following treatment with CTP-543 were statistically significant.
The robust clinical results observed in the trial supported the Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and the progression of CTP-543 into the THRIVE-AA pivotal Phase 3 clinical program. The Company recently reported positive topline data from the THRIVE-AA1 trial, and topline data from the THRIVE-AA2 trial is expected in the third quarter of 2022.
"We are very pleased that the results from this trial are published in this very prestigious journal and that its broad readership across the field of dermatology will see the first published results of CTP-543 in patients with alopecia areata," said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals and a co-author of the publication. "Today's JAAD publication further emphasizes the growing body of literature showing the importance of the JAK mechanism in alopecia areata and the potential therapeutic utility of CTP-543 as a new treatment option for this important medical condition."
CTP-543 Phase 2 Trial Results
The Phase 2 trial was a randomized, double-blind, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate to severe alopecia areata. A total of 149 patients were randomized to receive one of three doses of CTP-543 (4 mg, 8 mg or 12 mg) or placebo, administered twice-daily. The primary outcome measure utilized the Severity of Alopecia Tool (SALT) after 24 weeks of dosing.
Patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the SALT score. The 8 mg twice-daily and 12 mg twice-daily groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT from baseline at 24 weeks. At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily compared to placebo also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale. For patients in the 4 mg cohort, the relative reduction in their overall SALT score from baseline was not significantly different from placebo.
In the Phase 2 study, CTP-543 was generally well tolerated and safety results were consistent with the known safety profile of JAK inhibitors. There was one serious adverse event reported in the 12 mg dose group where the patient was able to complete the trial after a brief dose interruption.
A copy of the publication entitled, "Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus Kinase inhibitor, in moderate-to-severe alopecia areata" is available online on the JAAD website and supplemental materials are available on Mendeley.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserve
Comcert Pharmaceuticals Announced Phase 2 Dose‑Ranging Clinical Trial Results of CTP‑543 in Patients with Alopecia Areata published in the Journal of the American Academy of Dermatology
7:08 am ET June 7, 2022 (Benzinga) Print
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the publication of safety and efficacy data from the randomized, double-blind, placebo-controlled dose-ranging Phase 2 clinical trial for CTP‑543 in the Journal of the American Academy of Dermatology (JAAD). CTP-543 is an investigational oral Janus Kinase (JAK) inhibitor being evaluated in ongoing clinical trials for the treatment of adults with moderate to severe alopecia areata, an autoimmune disease in which the immune system attacks hair follicles and results in hair loss. The publication reports clinically meaningful and statistically significant scalp hair regrowth after 24 weeks of treatment with CTP-543 in both the 8 mg twice-daily and 12 mg twice-daily dose groups in patients with alopecia areata.
"We have made so much progress in alopecia areata in so short a time, and it is utterly exciting to see JAK inhibitors advance as a potential treatment for alopecia areata," said Brett King, M.D., Department of Dermatology, Yale University School of Medicine and lead author of the publication. "The therapeutic response in patients as early as 12 weeks in this trial is significant, and we hope that with continued development CTP-543 will become a treatment option for the many people suffering from this serious autoimmune disease."
The publication highlights the establishment of two doses of CTP-543 with statistically significant hair regrowth and a generally well tolerated safety profile in patients with moderate to severe alopecia areata. Additionally, patient-reported outcomes of improvement following treatment with CTP-543 were statistically significant.
The robust clinical results observed in the trial supported the Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and the progression of CTP-543 into the THRIVE-AA pivotal Phase 3 clinical program. The Company recently reported positive topline data from the THRIVE-AA1 trial, and topline data from the THRIVE-AA2 trial is expected in the third quarter of 2022.
"We are very pleased that the results from this trial are published in this very prestigious journal and that its broad readership across the field of dermatology will see the first published results of CTP-543 in patients with alopecia areata," said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals and a co-author of the publication. "Today's JAAD publication further emphasizes the growing body of literature showing the importance of the JAK mechanism in alopecia areata and the potential therapeutic utility of CTP-543 as a new treatment option for this important medical condition."
CTP-543 Phase 2 Trial Results
The Phase 2 trial was a randomized, double-blind, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate to severe alopecia areata. A total of 149 patients were randomized to receive one of three doses of CTP-543 (4 mg, 8 mg or 12 mg) or placebo, administered twice-daily. The primary outcome measure utilized the Severity of Alopecia Tool (SALT) after 24 weeks of dosing.
Patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the SALT score. The 8 mg twice-daily and 12 mg twice-daily groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT from baseline at 24 weeks. At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily compared to placebo also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale. For patients in the 4 mg cohort, the relative reduction in their overall SALT score from baseline was not significantly different from placebo.
In the Phase 2 study, CTP-543 was generally well tolerated and safety results were consistent with the known safety profile of JAK inhibitors. There was one serious adverse event reported in the 12 mg dose group where the patient was able to complete the trial after a brief dose interruption.
A copy of the publication entitled, "Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus Kinase inhibitor, in moderate-to-severe alopecia areata" is available online on the JAAD website and supplemental materials are available on Mendeley.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserve
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