Exhibit 99.1
 
concertimage8ka08.jpg
NEWS RELEASE

For additional information contact:
Justine Koenigsberg (investors)
Concert Pharmaceuticals, Inc.
(781) 674-5284
ir@concertpharma.com

Kathryn Morris (media)
The Yates Network
(914) 204-6412
kathryn@theyatesnetwork.com

FOR IMMEDIATE RELEASE

Concert Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Company Update
Conference Call Scheduled Today at 8:30 a.m. EDT

Lexington, MA (August 1, 2019) -- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the second quarter of 2019.
“As we move into the second half of the year, we are advancing our two wholly-owned clinical candidates for important chronic diseases that together affect millions of patients: CTP-543 for alopecia areata and CTP-692 for schizophrenia,” said Roger D. Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “For CTP-543, we are focused on completing the necessary clinical and development activities for the briefing package that we plan to submit to FDA to support an end of Phase 2 meeting early next year. Given the favorable safety profile observed in Phase 1 testing for CTP-692, we are preparing for our Phase 2 efficacy study to begin in the fourth quarter of 2019.”
Recent Business Highlights and Upcoming Milestones
CTP-543: a Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata
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.

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