Concert’s initial alopecia data fall short against Pfizer, prompting investor blow back
On Monday, Concert reported the 8 mg dose of CTP-543 — its modified version of Incyte’s $INCY Jakafi — had brought about a ≥ 50% relative reduction on the Severity of Alopecia Tool (SALT) score versus placebo (p <0.001) in 47% of patients with moderate-to-severe alopecia areata at 24 weeks, thereby meeting the main goal of the Phase IIa study. Significant differences against the placebo were observed at week 12 and hair regrowth did not appear to plateau at week 24, the Lexington, Massachusetts-based company said.
However, separate Phase II data on Pfizer’s JAK inhibitors — PF-06651600 and PF-06700841 — showed the two drugs stimulated hair growth at a faster rate, demonstrating statistically significant separation from placebo as early as week 6 and week 4, respectively, the drugmaker reported in September.
Concert’s stock lost more than a fifth of its value on Monday, with its shares down 21.61% at $12.59 at the closing bell.
Alopecia areata is an autoimmune disorder which targets the hair follicles, causing hair loss typically on the scalp, but the disease can also affect the beard, eyebrows, and other areas of the body. In the United States, approximately 500,000 individuals have alopecia areata, but it is incurable and there are no FDA-approved treatments for it. However, there are several treatments used off-label to manage the disease, most commonly corticosteroids. Calcineurin inhibitors, immunotherapies, and hair-growth-stimulating solutions are also employed, according to the FDA.
The smallest dose (4 mg) of Concert’s CTP-543 did not not induce a statistically significant improvement in symptoms, and data on the highest dose (12 mg) are expected in the third quarter of next year, the company added on Monday. The most common side effects observed in the trial were headache, upper respiratory tract infection, cough, acne and nausea, and no serious adverse events were reported.
JAK inhibitors are believed to play an important role in inflammatory processes as they are involved in signaling for over 50 cytokines and growth factors, many of which drive immune-mediated conditions.