Carbylan Therapeutics completes enrollment in Phase III pivotal trial of Hydros-TA biodegradable hydrogel beads for osteoarthritis pain

Carbylan Therapeutics announced that it has completed enrollment of its 510 subject COR1.1 Phase III pivotal trial of Hydros-TA for the treatment of pain associated with osteoarthritis. 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 III program design. The trial is comprised of subjects with Kellgren-Lawrence Grade 2 and 3 osteoarthritis (OA) of the knee. Subjects were randomized equally between three treatment arms: Hydros-TA, Hydros and TA (Triamcinolone Acetonide). 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.

Comment:Hydros Joint Therapy is an intra-articular viscosupplement injection therapy comprised of bacterially derived hyaluronic acid (HA) which is chemically modified to form biodegradable hydrogel beads. Hydros was designed to provide sustained pain relief for up to six months with a single injection. HydrosTA Joint Therapy has a dual mode of action, which traps a low dose of triamcinolone acetonide (corticosteroid) inside the Hydros hydrogel beads. Hydros-TA was designed to provide faster acting, longer lasting pain relief than either viscosupplements or steroids alone.