Concert Pharmaceuticals, a company recently acquired by Sun Pharmaceutical Industries Limited, on Sunday 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<0.0001).Sun Pharma announces acquisition of Concert Pharmaceuticals
The key secondary endpoints were the percentage of responders on a Satisfaction of Hair Patient Reported Outcome (SPRO) scale at Week 24 and the percentage of patients achieving absolute SALT scores of 20 or less at each of Weeks 20, 16, 12 and 8. 47% of patients in the 8 mg twice-daily group and 52% of patients in the 12 mg twice-daily group reported being “satisfied” or “very satisfied,” as compared to 2% of patients in the placebo group. The treatment difference for both groups relative to placebo was statistically significant. SALT scores of 20 or less at Weeks 20, 16 and 12 were statistically significant in both dose groups.
The safety profile seen with deuruxolitinib in THRIVE-AA2 was consistent with previous studies. The most common (≥5%) side effects in any dose group were COVID-19 infection, nasopharyngitis, increased blood creatine kinase levels, acne and headache. No pulmonary embolisms or deep vein thromboses were observed in the trial. Two patients treated with the 8 mg twice-daily dose and two patients treated with the 12 mg twice-daily dose developed herpes zoster (shingles). Five serious adverse events were reported in five patients, with one in the 8 mg twice-daily dose group that was assessed as possibly related to treatment.
“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, PlaceboControlled 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.
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