Phase III trial of Hydros-TA (hyaluronic acid beads) meets one endpoint in pain associated with osteoarthritis- Carbylan Therapeutics

Carbylan Therapeutics has announced top-line results from COR1.1, its first Phase III trial of Hydros-TA (hyaluronic acid beads) for the treatment of pain associated with osteoarthritis of the knee. In the COR1.1 study, Hydros-TA met the first of its two primary endpoints, demonstrating a statistically significant improvement from baseline in the WOMAC A pain score at week 2 versus Hydros (hyaluronic acid alone). In addition, Hydros-TA maintained a significant reduction in pain from baseline over 26 weeks. However, patients in the TA arm continued to show an unexpected significant reduction in pain through 26 weeks. Given the comparable effectiveness at 26 weeks, COR1.1 did not meet its second primary endpoint. Hydros-TA was generally well tolerated with no treatment related serious adverse events (SAEs), and adverse events (AEs) were mostly mild and included arthralgia (knee pain) and swelling.

COR1.1 was a 560 patient, international, multi-center, randomized, double-blind study designed to evaluate the safety and efficacy of Hydros-TA. The primary endpoints of the trial were changes from baseline in the WOMAC A pain scores at week 2 for Hydros-TA versus Hydros and at week 26 for Hydros-TA versus TA, or triamcinolone acetonide (10 mg), as well as a safety assessment of adverse events.

Comment:Hydros Joint Therapy is an intra-articular viscosupplement injection therapy comprised of bacterially derived hyaluronic acid 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.