First Phase 3 trial, COR1.1, on track for first quarter 2016 data availability
Second Phase 3 trial, COR1.2, to enroll first patients in early 2016 with IND in first half 2016
NDA submission anticipated mid-2017
PALO ALTO, Calif., July 15, 2015 (GLOBE NEWSWIRE) -- Carbylan Therapeutics (NASDAQ:CBYL), a specialty pharmaceutical company focused on the development of novel and proprietary combination therapies, today provided an update regarding its Phase 3 clinical program.
As was recently announced, Carbylan has completed enrollment of its first pivotal phase 3 trial, COR1.1, which enrolled over 500 patients.
As the Company moves forward with clinical development in anticipation of its second Phase 3 trial, COR1.2, Carbylan has been transferring its drug manufacturing processes to two contract manufacturers (CMOs) to replace in-house manufacturing and provide for commercial-scale capabilities. In this transfer process, unforeseen delays were recently encountered, which have required a revision to the production timeline. Carbylan has been working closely with its CMOs on a revised timeline, and now anticipates enrolling the first patients in its COR1.2 trial in early 2016. In addition, the Company plans to open an Investigational New Drug Application (IND) and begin enrolling U.S. patients in the first half of 2016. Carbylan expects data availability from COR1.2 and the submission of its New Drug Application (NDA) for Hydros-TA by mid-2017. The Company had previously anticipated an NDA submission in early 2017.
The revised Phase 3 timeline does not alter anticipated availability of data from the Company’s COR1.1 trial during the first quarter of 2016.
About Carbylan Therapeutics
Carbylan is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel and proprietary combination therapies that address significant unmet clinical needs. The Company’s lead product candidate, Hydros-TA, is a proprietary, cross-linked combination of low dose corticosteroid and novel hyaluronic acid viscosupplement, designed to provide both rapid and sustained osteoarthritis pain relief via a single intra-articular injection.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Carbylan Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding the timing of, and Carbylan’s ability to successfully complete, clinical and regulatory prerequisites and to bring Hydros-TA to market. Such forward-looking statements involve substantial risks and uncertainties that could cause Carbylan’s future results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing and success of regulatory filings and other matters that could affect the availability or commercial potential of Carbylan’s drug candidates. Carbylan Therapeutics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Carbylan’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 21, 2015, and its subsequent periodic reports to be filed with the Securities and Exchange Commission.
CONTACT: The Ruth Group David Burke/Lee Roth 646-536-7009/7012 dburke@theruthgroup.com/lroth@theruthgroup.com
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