Loading...
Loading...
Shares of
Carbylan Therapeutics Inc, a nano-cap clinical-stage specialty pharmaceutical company, plunged nearly 50 percent after the company
announced top-line results from a Phase 3 trial, COR1.1.
COR1.1 was a 560 patient, international, multi-center and randomized double-blind study that evaluated 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
Carbylan Therapeutics reported that the study met the first of its 2 primary endpoints and demonstrated a statistically significant improvement from baseline in the WOMAC A pain score at week 2 versus Hydros. However, the company noted that 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.
"We are pleased to have achieved one of our primary endpoints in our COR1.1 trial. This demonstrates that Hydros-TA can provide early onset of pain relief with a low-dose corticosteroid," stated David Renzi, President and CEO of Carbylan Therapeutics, "However, patients who received the corticosteroid triamcinolone acetonide, or TA, showed a prolonged pain-reduction through 26 weeks, which was unexpected based on clinical experience and published literature. We are very pleased that Hydros-TA and Hydros performed as expected throughout the course of the study, and we are actively reviewing the trial data in order to better understand the reported duration of effect of TA at 26 weeks. We look forward to sharing with our investors our future plans for the continued development of Hydros-TA."
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted In: NewsCarbylan TherapeuticsClinical Stage CompaniesCOR1.1David RenziHydrosSpecialty Pharmaceutical CompaniesWOMAC A
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
