Therapy Areas: Autoimmune
Concert Pharmaceuticals Initiates THRIVE-AA1 Phase 3 Clinical Trial Evaluating CTP-543 for Alopecia Areata
4 November 2020 - - US-based clinical stage biopharmaceutical company Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) has initiated THRIVE-AA1, the first Phase 3 clinical trial to evaluate the efficacy and safety of CTP-543, an oral Janus kinase inhibitor, in adult patients with moderate to severe alopecia areata, the company said.

The company expects to report topline results from THRIVE-AA1 in 2022.

A second Phase 3 trial, THRIVE-AA2, is expected to begin in the first half of 2021.

The initiation of THRIVE-AA1 follows an end-of-phase 2 meeting where Concert discussed key aspects of its Phase 3 program and registration strategy with the US Food and Drug Administration.

The end-of-phase 2 meeting with the FDA was held following positive results from a dose-ranging Phase 2 trial of CTP-543 in patients with moderate to severe alopecia areata.

Under current timelines, the company believes that positive results from two Phase 3 trials could serve as the basis for submitting a New Drug Application in early 2023 for CTP-543 for the treatment of moderate to severe alopecia areata in adult patients.

THRIVE-AA1 (NCT04518995) is a randomized, double-blind, placebo-controlled clinical trial in adult patients with moderate to severe alopecia areata at sites in the US, Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool.

CTP-543 is an 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 700,000 Americans at any given time.

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.

Concert Pharmaceuticals is a clinical stage 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 pipeline consists of clinical stage candidates targeting autoimmune and central nervous systems disorders, and a number of preclinical compounds that it is currently assessing.
Login
Username:

Password: