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|Late-Breaking Phase 3 Data at AAD 2023 Show Oral Investigational Medicine Deuruxolitinib Significantly Improved Scalp Hair Regrowth in Alopecia Areata|
|By: PR Newswire Association LLC. - 18 Mar 2023||Back to overview list
MUMBAI, India and PRINCETON, N.J. , March 18, 2023 /PRNewswire/ -- Concert Pharmaceuticals ("Concert"), a company recently acquired by Sun Pharmaceutical Industries Limited (including its subsidiaries and/or associated companies, "Sun Pharma"), today announced the presentation of data from its Phase 3 clinical trial, THRIVE-AA2. The presentation highlights THRIVE-AA2 study results evaluating the oral investigational medicine deuruxolitinib in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. The THRIVE-AA2 data are being presented by Brett King, M.D, Ph.D., Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA2, during the American Academy of Dermatology's (AAD) 2023 Annual Meeting Late Breaking News Session.
The primary efficacy endpoint for THRIVE-AA2 was the percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less at week 24 of treatment compared to placebo. As previously disclosed in the positive topline results reported by Concert, significant improvements in scalp hair regrowth were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of deuruxolitinib. The AAD presentation includes new data from the THRIVE–AA2 study showing the ability of deuruxolitinib to achieve near-complete or complete scalp hair regrowth, with 21% (8 mg twice-daily) and 35% (12 mg twice-daily) of patients, compared with 0% receiving placebo, achieving a SALT score of 10 or less after 24 weeks.
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022:
"These data are highly encouraging and support the potential of deuruxolitnib to regrow hair on the scalp, eyebrows and eyelashes in patients with alopecia areata, and in many cases with a rapid onset of effect," stated Dr. King.
"We are pleased by the consistency of the Phase 3 results generated in the THRIVE-AA clinical program," said James V. Cassella, PhD, Chief Development Officer of Concert. "Based on the strength of the THRIVE-AA2 data along with data from the THRIVE-AA1 trial and the continuation of our Breakthrough Therapy designation, deuruxolitinib has the potential to be a best-in class treatment option for alopecia areata. We look forward to filing our deuruxolitinib New Drug Application with the Food and Drug Administration next quarter and bringing this potential new treatment option to patients living with alopecia areata as soon as possible."
Details from the oral presentation, entitled "Results from THRIVE-AA2: A Double Blind, Placebo-Controlled Phase 3 Clinical Trial of Deuruxolitinib (CTP-543), an Oral JAK Inhibitor, in Adult Patients With Moderate to Severe Alopecia Areata," is available in the Scientific Presentations section of Concert's website.
Patients enrolled in THRIVE-AA2 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients was approximately 87.9 (corresponding to approximately 12% average scalp hair coverage).
These data, along with data from the first Phase 3 clinical trial, THRIVE-AA1, are intended to form the basis of a New Drug Application (NDA) planned to be submitted to the U.S. Food and Drug Administration (FDA) in the first half of 2023.
About Deuruxolitinib and Alopecia Areata
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited treatment options available for alopecia areata.
About Sun Pharmaceutical Industries, Inc.
On March 6, Sun Pharma announced the successful completion of its acquisition of Concert Pharmaceuticals, Inc., a late-stage clinical biopharmaceutical company that is developing deuruxolitinib, a novel, deuterated, oral JAK1/2 inhibitor, for the potential treatment of adult patients with moderate to severe alopecia areata. For additional information on the acquisition, please read the acquisition closure press release.
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SOURCE Sun Pharma
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