McWherter

CymaBay Announces Publication of Two-year Safety and Efficacy Results of Seladelpar in Patients with Primary Biliary Cholangitis

Retrieved on: 
Wednesday, November 1, 2023

Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar.

Key Points: 
  • Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar.
  • The objectives were to evaluate the long-term safety, tolerability, and efficacy of seladelpar at 5 mg and 10 mg once daily throughout 2-years.
  • In addition, ALP normalization was achieved in 23% and 42% in patients at one and two years, respectively.
  • In the study long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury in the second year of treatment.

CymaBay Therapeutics Announces Publication of Results From a 52-Week, Open-Label, Phase 2 Study of Seladelpar in Patients With Primary Biliary Cholangitis

Retrieved on: 
Monday, April 4, 2022

Patients with PBC are in need of new therapies that are well tolerated and provide clinical benefits.

Key Points: 
  • Patients with PBC are in need of new therapies that are well tolerated and provide clinical benefits.
  • Patients need therapies to address their symptoms and the results of this open label study suggest that seladelpar has the potential to provide symptom relief.
  • CymaBay is currently enrolling RESPONSE, a global phase 3 study of seladelpar in patients with PBC that is intended to confirm these results.
  • The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients.