CymaBay shares results from phase 3 RESPONSE trial for seladelpar
CymaBay Therapeutics has announced positive topline results from its phase 3 RESPONSE study which assessed the safety and efficacy of seladelpar for the treatment of adult patients with primary biliary cholangitis (PBC).
The trial reached all of its primary and key secondary endpoints, with 61.7% of patients on a 10mg dose meeting the primary composite endpoint related to serum alkaline phosphatase and bilirubin at 12 months compared to only 20% of the placebo group. Treatment with seladelpar also demonstrated a statistically significant reduction in pruritus, or itch, after six months of treatment.
Results from the trial will support the company in seeking regulatory approval from the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Sujal Shah, president and CEO at CymaBay, stated: “The results from RESPONSE support our conviction that seladelpar has the potential to advance patient care by improving measures of disease activity and reducing symptom burden. They are consistent with previous findings in what we believe has been an exceptionally robust development programme in PBC. We believe that the delpar mechanism is unique with its ability to normalise markers of cholestasis coupled with reductions in pruritus. Many patients with PBC suffer from incessant itching while knowing that their disease can progress to the point where a liver transplant could become their only option. These results represent an important step toward potentially changing the treatment paradigm for patients living with PBC. We deeply appreciate the participation of patients across all of our studies in PBC and the support we have received from investigators, their teams and our many partners involved in advancing the development of seladelpar through this significant milestone.”
AstraZeneca and Daiichi Sankyo have shared positive high-level results from the TROPION-Breast01 phase 3 trial, …
Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …