Concert Pharmaceuticals Announces CTP-543 Alopecia Areata Data Selected for Late-Breaker Oral Presentation at 2020 EADV Virtual Congress

Rhea-AI Summary

Concert Pharmaceuticals (NASDAQ: CNCE) will present clinical data on CTP-543 for treating alopecia areata at the 29th EADV Virtual Congress from October 29-31, 2020. The presentation will share results from an ongoing open-label extension study, focusing on the long-term safety and treatment effects of CTP-543. This oral selective inhibitor of Janus kinases has received Breakthrough Therapy and Fast Track designations from the FDA. The Company plans to initiate Phase 3 evaluation of CTP-543 in Q4 2020.

Positive

• CTP-543 received Breakthrough Therapy designation from the FDA for treating alopecia areata.
• Fast Track designation by the FDA for CTP-543 expedites its development process.
• Upcoming Phase 3 evaluation planned for Q4 2020 indicates progress in clinical development.

Negative

• None.

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it will present clinical data on CTP-543 for the treatment of alopecia areata as a late-breaker oral presentation at the 29^th European Academy of Dermatology and Venereology (EADV) Virtual Congress. The meeting will be held virtually October 29-31, 2020. The oral presentation will highlight new data from an ongoing open label extension study evaluating long-term safety and treatment effects of CTP-543 in patients with moderate to severe alopecia areata.

The details of the presentation are as follows:

• Title: Initial Results from a Long-Term, Open-Label Extension Study with CTP-543, an Oral Janus Kinase Inhibitor, in Patients with Moderate to Severe Alopecia Areata
• Date and Time: Thursday, October 29, 2020, 3:00 – 3:15 pm Central European Time
• Session: D1T03.3C: Late-Breaking News Session
• Location: EADV Virtual Meeting. Registration is required to participate: https://eadvvirtualcongress.org/registration/

About CTP-543 and Alopecia Areata

CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2. The U.S. Food and Drug Administration (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. The Company expects to begin Phase 3 evaluation of CTP-543 in the fourth quarter of 2020. Additional information on the upcoming trial is available on www.clinicaltrials.gov.

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 700,000 Americans at any given time¹. 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 no drugs approved by the FDA for the treatment of alopecia areata.

The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the FDA’s Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs. The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

¹ Benigno M. Clinical, Cosmetic and Investigational Dermatology 2020