Presentation of deuruxolitinib THRIVE-AA1 phase III study results in alopecia areata at World Congress for Hair Research

The presentation highlights THRIVE-AA1 study results evaluating Concert’s investigational oral medicine deuruxolitinib (CTP-543) in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. The World Congress presentation includes new analyses from THRIVE- AA1 showing the effect of deuruxolitinib on regrowth of scalp hair based on disease severity and duration of current episode of hair loss. The data are being presented by Brett King, M.D., Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA1.

“These new data analyses are important to inform our treatment of patients with varying degrees of disease severity and duration of current episode of hair loss. For patients receiving deuruxolitinib in THRIVE-AA1, the data show meaningful and significant improvement in patients with the most severe disease and those with longer duration of current episode. The data show, however, that more patients succeed with treatment when they are treated before they lose all of their scalp hair and when they are treated earlier in an episode of severe loss” stated Dr. King.

In THRIVE-AA1, significant improvements in scalp hair regrowth compared to placebo were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of deuruxolitinib, as previously disclosed in the positive topline results reported by Concert earlier this year. Treatment with deuruxolitinib was generally well tolerated.

The newly presented analyses on disease severity and duration of current episode of hair loss from THRIVE-AA1 include: i. For patients with an absolute Severity of Alopecia Tool (SALT) score less than 95 at baseline, 43% and 57% of the 8 mg twice-daily and 12 mg twice-daily deuruxolitinib dose groups, respectively, achieved a SALT score of 20 or less at Week 24, compared to 1% of patients in the placebo group (p<0.0001). the onset of effect was significant as early as week 8 for both doses (p><0.001). ii. for patients with a salt score greater than or equal to 95 (representing complete or nearly complete scalp hair loss) at baseline, 20% and 30% of the 8 mg twice-daily and 12 mg twice-daily deuruxolitinib dose groups, respectively, achieved a salt score of 20 or less at week 24, compared to 0% of patients in the placebo group (p><0.0001). the onset of effect was significant as early as week 12 for both doses (p><0.01). iii.for patients whose duration of current episode of hair loss was less than 4 years, the proportion of patients achieving a salt score of 20 or less by week 24 was 33% and 48% in the deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups, respectively, compared to 1% of patients in the placebo group (p><0.0001). iv. for patients whose duration of current episode of hair loss was greater than or equal to 4 years, the proportion of patients achieving a salt score of 20 or less by week 24 was 23% and 29% in the deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups, respectively, compared to 0% of patients in the placebo group (p><0.0001).

Deuruxolitinib was generally well-tolerated in THRIVE-AA1, consistent with its other Phase II and Phase III studies. The most common ( greater than 5%) side effects in any dose group were headache, acne, upper respiratory infection, increased creatine kinase levels, COVID-19 infection and nasopharyngitis. Upper respiratory infections were greater in the placebo group than in either of the deuruxolitinib dose groups. No pulmonary embolisms or deep vein thromboses were observed in the trial. One patient treated with the 8 mg twice-daily dose and one patient treated with the 12 mg twice-daily dose developed herpes zoster (shingles). Serious adverse events were reported in nine patients, with only one patient (in the 8 mg twice-daily dose group) having events (2) that were assessed as possibly related to treatment. Four patients who reported serious adverse events were in the placebo group.