LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today appear the admission of a U.S.-based Phase 2 analytic balloon evaluating CTP-656 (deuterated ivacaftor), a aing bearing CFTR potentiator actuality developed for the analysis of cystic fibrosis. CTP-656 was created based on Concert’s appliance of deuterium allure to adapt ivacaftor, which is commercially accessible beneath the cast name Kalydeco® and is the accepted accepted of affliction for cystic fibrosis patients with gating mutations. Topline after-effects of the Phase 2 balloon of CTP-656 are accepted by anniversary 2017.
“We are aflame to admit our Phase 2 balloon with CTP-656 in individuals with cystic fibrosis,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “In adverse to Kalydeco, Phase 1 analytic after-effects from CTP-656 abutment dosing it once-daily with food, after attention to the fat agreeable of the food, potentially enabling CTP-656 to abutment bigger adherence and accommodate absolute apple allowances for patients with cystic fibrosis.”
The Phase 2 analytic balloon is a randomized, parallel-group, double-blind, placebo-controlled, analytic balloon to appraise the assurance and ability of CTP-656 in cystic fibrosis patients with gating mutations. Patients enrolled in the 28-day abstraction will accept one of three doses (20 mg, 100 mg and 150 mg) of CTP-656 once-daily or placebo. There will additionally be an open-label Kalydeco comparator arm in the trial. Approximately 30-40 patients will be enrolled in the Phase 2 balloon which will be conducted in assorted centers in the U.S. The primary endpoint of the Phase 2 balloon is a change from baseline in diaphoresis chloride at Day 28. Secondary endpoints accommodate change in percent predicted affected expiratory aggregate (FEV1) and change from baseline in CFQ-R Respiratory Domain. The abstraction is actuality conducted aural the Cystic Fibrosis Foundation’s Therapeutic Development Network (TDN). Additional advice about the Phase 2 analytic balloon is accessible at www.clinicaltrials.gov.
In Phase 1 analytic evaluations, CTP-656 provided above key acknowledgment ambit compared to Kalydeco. CTP-656 was well-tolerated and its assurance contour was commensurable to that of Kalydeco. No austere adverse contest were appear in Phase 1 studies.
About CTP-656 and Cystic Fibrosis
CTP-656 is a atypical CFTR potentiator that may action aing generation, once-daily dosing and was developed by Concert’s atypical appliance of deuterium allure to adapt ivacaftor. Ivacaftor is marketed by Vertex Pharmaceuticals beneath the cast name Kalydeco. Concert is initially developing CTP-656 as a abeyant monotherapy analysis for cystic fibrosis due to gating mutations of the gene that encodes for cystic fibrosis transmembrane conductance regulator (CFTR), a protein, which regulates apparatus of sweat, fungus approval and digestion. The Aggregation additionally intends to accredit potentially added able combinations to amusement added mutations, including zygous F508del, by partnering with added potentially commutual CFTR modulators.
Cystic fibrosis is a life-threatening, ancestral abiogenetic ache that has systemic furnishings and can account decidedly bargain lung and digestive arrangement function. According to the Cystic Fibrosis Foundation, an estimated 70,000 bodies common accept cystic fibrosis.
Concert Pharmaceuticals is a analytic date biopharmaceutical aggregation focused on applying its DCE Platform® (deuterated actinic article platform) to actualize atypical medicines advised to abode unmet accommodating needs. The Company’s access starts with accustomed drugs in which deuterium barter has the abeyant to enhance analytic safety, tolerability or efficacy. Concert has a ample activity of avant-garde medicines targeting pulmonary diseases, including cystic fibrosis, axial afraid systems (CNS) disorders, as able-bodied as autoimmune and anarchic diseases. For added advice amuse appointment www.concertpharma.com.
Cautionary Note on Forward Looking Statements
Any statements in this columnist absolution about our approaching expectations, affairs and prospects, including statements about analytic development and outcomes of CTP-656 and added statements absolute the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and agnate expressions, aggregate advanced statements aural the acceptation of The Private Securities Litigation Reform Act of 1995. Actual after-effects may alter materially from those adumbrated by such advanced statements as a aftereffect of assorted important factors, including: the uncertainties inherent in the admission of approaching analytic trials, availability and timing of abstracts from advancing and approaching analytic trials and the after-effects of such trials, whether basic after-effects from a analytic balloon will be predictive of the final after-effects of that balloon or whether after-effects of aboriginal analytic trials will be apocalyptic of the after-effects of after analytic trials, expectations for authoritative approvals and added factors discussed in the “Risk Factors” area of our best contempo Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in added filings that we accomplish with the Securities and Exchange Commission. In addition, any advanced statements included in this columnist absolution represent our angle alone as of the date of this absolution and should not be relied aloft as apery our angle as of any consecutive date. We accurately abandon any obligation to amend any advanced statements included in this columnist release.
Concert Pharmaceuticals Inc., the Concert Pharmaceuticals Inc. logo and DCE Belvedere are registered trademarks of Concert Pharmaceuticals, Inc.Kalydeco is a registered brand of Vertex Pharmaceuticals, Inc.
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