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Carbylan completes enrollment for its Phase 3 trial of Hydros-TA in osteoarthritis

9 June 2015  •  Author: Victoria White

Carbylan Therapeutics has completed enrollment of its 510 subject COR1.1 Phase 3 pivotal trial of Hydros-TA for the treatment of pain associated with osteoarthritis.

osteoarthritis-hydros-ta

Subjects were enrolled at 30 clinical sites in Canada, Australia, New Zealand, The Netherlands, Hungary and Curacao.

COR1.1 is the first of two pivotal trials of Hydros-TA as part of Carbylan’s Phase 3 programme design. The trial is comprised of subjects with Kellgren-Lawrence Grade 2 and 3 osteoarthritis (OA) of the knee. Subjects were randomised equally between three treatment arms: Hydros-TA, Hydros and TA (Triamcinolone Acetonide).

Top-line results from the Phase 3 trial of Hydros-TA are expected in early 2016

The objective of the trial is to demonstrate the safety and efficacy of Hydros-TA and the contribution of each of the two components in this therapy. The primary endpoints are the change from baseline in WOMAC A (pain) subscale scores for Hydros-TA versus Hydros at two weeks and Hydros-TA versus TA at 26 weeks. Secondary endpoints include WOMAC C (function) changes, subject and physician global assessment changes and OMERACT-OARSI responder analysis. The Company expects top-line data from this trial in early 2016.

David Renzi, President and CEO of Carbylan Therapeutics, commented, “The completion of COR1.1 subject enrollment is a significant milestone for Carbylan and an important step toward our goal of bringing Hydros-TA to market. We believe this product can provide a potentially best in class alternative to the treatment options currently available for patients suffering from the pain of osteoarthritis by utilizing our proprietary crosslinking technology to combine a low dose steroid with our novel hyaluronan in order to offer both rapid and sustained pain relief.”

For more information about Carbylan Therapeutics, please visit www.carbylan.com.

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