Please wait while we load the requested 10-Q report or click the link below:
CTP-543 Third Dose, 12 mg Twice-Daily, Phase 2 Topline Data Expected Third Quarter of 2019. The Company expects to report topline results from the final cohort in its ongoing CTP-543 Phase 2 trial in the third quarter of 2019. The Phase 2 trial was designed to evaluate the safety and efficacy of three doses (4, 8, and 12 mg twice-daily) of CTP-543 compared to placebo in patients with moderate-to-severe alopecia areata. Interim results from the initial two cohorts for this dose-ranging trial, first reported in November 2018, showed that treatment with CTP-543 administered at an 8 mg twice-daily dose for 24 weeks met the primary endpoint with a statistically significant greater hair regrowth rate compared to placebo.
CTP-543 Open Label Trial Evaluating 8 mg Twice-Daily vs. 16 mg Once-Daily Fully Enrolled. In May 2019, the Company announced that an open-label dose regimen trial evaluating CTP-543 for the treatment of alopecia areata at a dose of 8 mg twice-daily compared to a dose of 16 mg once-daily was fully enrolled. Topline results from the dose regimen trial are expected by year-end 2019. Data from this study, along with results from the Phase 2 dose-ranging trial, are intended to support an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2020 to review and discuss the Company’s registration pathway for CTP-543 for the treatment of alopecia areata.
The following information was filed by Concert Pharmaceuticals, Inc. (CNCE) on Thursday, August 1, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one quarter to another to evaluate Concert Pharmaceuticals, Inc.'s financial trajectory
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Concert Pharmaceuticals, Inc..