Concert’s CTP-543 helps regrow hair in patients with alopecia, meets primary trial objective

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Pharmaceutical gigs (NASDAQ: CNCE) said a Phase 3 trial of its oral drug CTP-543 achieved the primary endpoint of scalp hair regrowth at both doses in patients with moderate to severe alopecia, an autoimmune disease disorder causing hair loss from the scalp.

The late-stage study, called THRIVE-AA1, enrolled 706 adult patients ages 18 to 65 with moderate to severe alopecia at sites in the United States, Canada and Europe.

The trial assessed scalp hair regrowth after 24 weeks of treatment using the SALT score (a score of 100 represents complete scalp hair loss, while 0 represents no scalp hair loss scalp).

The company said a statistically significant proportion of patients treated with 8 mg twice daily or 12 mg twice daily of CTP-543 experienced greater scalp regrowth compared to placebo.

The primary endpoint was the percentage of patients achieving a SALT score ≤ 20 at 24 weeks.

Concert added that the proportion of patients achieving a SALT score of 20 or less (meaning 80% or more hair coverage was achieved) was 41.5% in the 12 mg dose group and 29.6% in the 8 mg dose group compared to 0.8% in the placebo group at 24 weeks.

The company noted that statistically significant hair regrowth was seen as early as eight weeks.

Concert said one patient in the 8mg group and one in the 12mg group developed shingles (shingles).

Serious adverse events were reported in nine patients, with one patient (in the 8 mg dose group) having events (2) that were assessed as possibly treatment-related.

The safety profile observed with CTP-543 was consistent with previous studies.

The company said these data, along with results, if positive, from a second Phase 3 trial, called THRIVE-AA2, are intended to form the basis of a new drug application that is expected to be submitted. to the United States Food and Drug Administration (FDA). in H1 2023.

Data from THRIVE-AA2 is expected in Q3 2022.