Concert Pharmaceuticals, a company recently acquired by Sun Pharmaceutical Industries, announced the presentation of data from its Phase 3 clinical trial, 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, 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, Chief Development Officer, 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,” added Cassella.