LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has achieved an $8 million milestone under its development and license agreement with Celgene Corporation (NASDAQ: CELG) for completion of the Phase 1 clinical evaluation of CTP-730. CTP-730 is a deuterium-modified analog of apremilast, a selective phosphodiesterase 4 (PDE4) inhibitor. Once-daily dosing of 50 mg of CTP-730 administered for 7 days in the Phase 1 trial demonstrated similar steady-state exposure to historical data for 30 mg of apremilast administered twice daily.
"We are encouraged by the favorable pharmacokinetic profile of CTP-730 observed in our Phase 1 clinical trials," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We believe that selective incorporation of deuterium in apremilast has resulted in a potential next generation anti-inflammatory agent."
The Phase 1 program included both single and multiple ascending dose trials. The Phase 1 clinical trials assessed the safety, tolerability and pharmacokinetics of CTP-730 in 85 healthy subjects. Treatment with CTP-730 was generally well tolerated and no serious adverse events were observed. The most common adverse events were similar to those already identified for apremilast.
The CTP-730 Phase 1 clinical trials were conducted under a 2013 development and license agreement established by Concert and Celgene to evaluate deuterium-modified compounds for inflammatory diseases and cancer. The collaboration is initially focused on the development of CTP-730, but has the potential to encompass up to three additional programs. Celgene is responsible for all development costs of CTP-730 beyond the Phase 1 clinical trials conducted by Concert.
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The Company is developing a broad pipeline targeting CNS disorders, genetic diseases, renal disease, inflammatory diseases and cancer. For more information, please visit www.concertpharma.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of CTP-730 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "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 of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results 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 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.
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