Concert Pharmaceuticals (NASDAQ: CNCE) this morning reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for CTP-656, a next generation CFTR potentiator for the treatment of cystic fibrosis. The designation provides incentives such as tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design, and potential market exclusivity for seven years following approval. In December 2016, Concert initiated a phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline data from the ongoing phase 2 trial is expected by year-end 2017. “We are developing CTP-656 to potentially offer advantages over standard of care, and our team is committed to advancing the clinical development program to address the unmet needs of individuals with cystic fibrosis,” Concert president and CEO Roger Tung, Ph.D. stated in the news release.
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Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, central nervous systems (CNS) disorders, as well as autoimmune and inflammatory diseases. For more information, please visit www.concertpharma.com
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