Clinical-stage specialty pharmaceutical firm Carbylan Therapeutics has completed the enrolment of patients in its 510 subject COR1.1 Phase III pivotal trial of Hydros-TA for the treatment of pain associated with osteoarthritis.
Hydros-TA is a proprietary and cross-linked combination of low dose corticosteroid and novel hyaluronic acid viscosupplement, which is being developed to provide both rapid and sustained osteoarthritis pain relief through a single intra-articular injection.
The company has enrolled subjects at 30 clinical sites in Canada, Australia, New Zealand, Netherlands, Hungary and Curacao.
COR1.1 is the first of two pivotal trials of Hydros-TA, which were designed by the firm as part of its Phase III programme.
Carbylan Therapeutics president and CEO David Renzi said: "The completion of COR1.1 subject enrolment is a significant milestone for Carbylan and an important step toward our goal of bringing Hydros-TA to market."
The study included subjects with Kellgren-Lawrence Grade 2 and 3 osteoarthritis (OA) of the knee and they were randomized equally between three treatment arms Hydros-TA, Hydros and Triamcinolone Acetonide (TA).
According to the firm, the objective of the study is to show the safety and efficacy of Hydros-TA and the contribution of each of the two components in this therapy.
The primary endpoints of the trial will be 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 will be WOMAC C (function) changes, subject and physician global assessment changes and OMERACT_OARSI responder analysis.
Carbylan plans to reveal the top-line data from this trial in early 2016.
Image: Severe osteoarthritis and osteopenia of the carpal joint and 1st carpometacarpel joint. Photo: courtesy of James Heilman, MD.