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Concert (CNCE) Initiates Second Phase III Hair Loss Study

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Concert Pharmaceuticals, Inc. (CNCE - Free Report) announced that it has initiated the second phase III study — THRIVE-AA2 — to evaluate its oral JAK inhibitor candidate, CTP-543, for treating alopecia areata (“AA”). The study will assess the efficacy and safety of the candidate in adult patients with moderate to severe AA. Top-line data from the study is expected in the second half of 2022.

We remind investors that the company initiated the first late-stage study — THRIVE-AA1 — to evaluate CTP-543 in moderate-to-severe AA patients in November last year. Top-line data from this study is expected in 2022.

Concert Pharmaceuticals believes data from these two late-stage AA studies can support a new drug application (NDA) for CTP-543 and expects to submit the same in early 2023. Please note that CTP-543 was discovered by applying its deuterium chemistry technology to modify Incyte Corporation’s (INCY - Free Report) oncology drug, Jakafi.

We note that both these phase III studies have almost similar designs. The two clinical studies will evaluate twice-daily 8mg or 12mg dose of CTP-543 versus twice-daily placebo in patients aged 18 to 65 years and who have experienced hair loss of 50% and more. The primary endpoint for both studies is Severity of Alopecia Tool (SALT) score, a measure of regrowth of scalp hair, of 20 or less after 24 weeks of treatment. The THRIVE-AA1 study will enroll approximately 700 patients while the enrollment target for the THRIVE-AA2 study is approximately 440 patients.

Please note that the company successfully completed a phase II study evaluating CTP-543 in moderate-to-severe AA patients in 2019. Data from the study showed that 24-week treatment with twice-daily 8mg or 12mg dose of the candidate resulted in 50% or more reduction in SALT score from baseline in statistically significant proportion of patients compared to placebo. Moreover, updated data from the phase II study announced in June 2020 demonstrated that 26% and 42% of patients treated with 8mg and 12mg of CTP-543, respectively, achieved a SALT score of 20 or less at week 24.

Data from the mid-stage study demonstrates the potential of the candidate as treatment for AA, which has significant unmet need with no FDA-approved therapy.

Shares of Concert Pharma have declined 68.5% so far this year compared with the industry’s decrease of 11.2%.

In February 2021, the company’s another key pipeline candidate, CTP-692, failed to meet the primary endpoint in a phase II study evaluating it as adjunctive treatment for schizophrenia. The company discontinued the development of the candidate following the failure. Moreover, the company sold its potential future milestones related to development of cystic fibrosis candidate, VX-561, to Vertex Pharmaceuticals (VRTX - Free Report) for $32 million earlier this month. Please note that Vertex had purchased worldwide development and commercialization rights to the candidate from Concert Pharmaceuticals in 2017.

The company is now primarily focused on development of its CTP-543. Interim data readouts from late-stage AA program could be important catalysts for the stock.

Zacks Rank and Stock to Consider

Concert Pharma currently has a Zacks Rank #4 (Sell).

Bioventus Inc. (BVS - Free Report) is a better-ranked drug stock, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bioventus’ earnings per share estimates have increased from 77 cents to $1.31 for 2021 and from 95 cents to $1.05 for 2022 over the past 30 days.

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