Concert Pharmaceuticals Announces That Results From CTP-543 THRIVE‑AA1 Phase 3 Trial in Patients With Alopecia Areata Selected for Late Breaking Presentation at EADV Congress

Rhea-AI Summary

Concert Pharmaceuticals (NASDAQ: CNCE) has announced that results from the Phase 3 THRIVE-AA1 trial for CTP-543 will be presented at the 31st EADV Congress in Milan, Italy, on September 10, 2022. CTP-543 is a JAK inhibitor for treating moderate to severe alopecia areata, a condition affecting about 1.5 million Americans. The presentation, led by Dr. Brett King, will cover efficacy and safety data, including Severity of Alopecia Tool (SALT) scores. CTP-543 has received Breakthrough Therapy and Fast Track designations from the FDA.

Positive

• CTP-543 shows promising results in the Phase 3 THRIVE-AA1 trial, indicating potential for effective treatment of alopecia areata.
• CTP-543 has received both Breakthrough Therapy and Fast Track designations from the FDA, expediting its development process.

Negative

• None.

LEXINGTON, Mass.--(BUSINESS WIRE)-- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that results from the first Phase 3 clinical trial of CTP-543 (THRIVE-AA1) in adult patients with moderate to severe alopecia areata will be presented as a late breaking oral presentation at the 31^st European Academy of Dermatology and Venereology (EADV) Congress. The oral presentation will be made by Dr. Brett King of Yale University School of Medicine and will highlight the topline efficacy and safety data from THRIVE-AA1 as well as results from new analyses of Severity of Alopecia Tool (SALT) scores and eyebrow and eyelash scales. The meeting will be held September 7-10, 2022 in Milan, Italy.

The details of the presentation are as follows:

• Title: Top-Line Results from THRIVE-AA1: A Phase 3 Clinical Trial of CTP-543 (deuruxolitinib), an Oral JAK Inhibitor, in Adult Patients with Moderate to Severe Alopecia Areata
• Date and Time: Saturday, September 10, 2022, 11:30-11:45 AM Central European Summer Time
• Session: D3T01.1: Late breaking news
• Location: MiCo Milano Convention Center, Golden Plenary

About CTP-543 and Alopecia Areata

CTP-543 is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. The FDA has granted CTP-543 Breakthrough Therapy designation for the treatment of adult patients with moderate to severe alopecia areata and Fast Track designation for the treatment of alopecia areata.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to approximately 1.5 million Americans at any given time.¹ The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited treatment options available for alopecia areata.

About Concert

Concert Pharmaceuticals is a late-stage clinical biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform^® (deuterated chemical entity platform). Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy. Concert’s lead product candidate CTP-543 is being developed for the treatment of alopecia areata, a serious autoimmune dermatological condition. Concert is also assessing a number of earlier-stage pipeline candidates. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

Cautionary Note on Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the development of CTP-543, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results, including safety profiles, from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for the timing of the submission of a New Drug Application, the availability of regulatory approvals and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

¹ Benigno M. Clinical, Cosmetic and Investigational Dermatology 2020

View source version on businesswire.com: https://www.businesswire.com/news/home/20220822005161/en/

Justine E. Koenigsberg (Investors)

Concert Pharmaceuticals, Inc.

(781) 674-5284

ir@concertpharma.com

Kathryn Morris (media)

The Yates Network

(914) 204-6412

kathryn@theyatesnetwork.com

Source: Concert Pharmaceuticals, Inc.

FAQ

What are the results of the THRIVE-AA1 trial for CTP-543?

The trial results will be presented on September 10, 2022, including topline efficacy and safety data.

When and where will the CTP-543 trial results be presented?

The results will be presented at the EADV Congress in Milan, Italy, from September 7-10, 2022.

What is CTP-543?

CTP-543 is an oral selective inhibitor of JAK1 and JAK2, developed for treating alopecia areata.

What designations has CTP-543 received from the FDA?

CTP-543 has received Breakthrough Therapy and Fast Track designations for alopecia areata.