SUN PHARMA - LATE-BREAKING PHASE 3 DATA AT AAD 2023 SHOW ORAL INVESTIGATIONAL MEDICINE DEURUXOLITINIB SIGNIFICANTLY IMPROVED SCALP HAIR REGROWTH IN ALOPECIA AREATA

MUMBAI - 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: The primary efficacy endpoint for THRIVE-AA2 was the percentage of patients achieving an absolute SALT score of 20 or less at Week 24 of treatment.

A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of deuruxolitinib experienced greater scalp regrowth compared to placebo. The proportion of patients achieving a SALT score of 20 or less (meaning 20 percent or less scalp hair loss) was 38.3 percent in the 12 mg twice-daily dose group and 33.0 percent in the 8 mg twice-daily dose group, compared to 0.8 percent of patients in the placebo group, at the 24-week endpoint. The treatment difference for both dose groups of deuruxolitinib relative to placebo was statistically significant (p