CymaBay Therapeutics Inc. (NASDAQ:CBAY) has announced its financial results for Q3 2020 and nine months ended September 30, 2020, and provided corporate updates.
CymaBay’s ENHANCE study data featured in The Liver Meeting® 2020
In Q3 and at the beginning of this month, the company made considerable progress in re-initiating the seladelpar development program in primary biliary cholangitis. The restart is well underway for the global phase 3 registration study, RESPONSE evaluating seladelpar in PBC patients. The study is on track to dose the first patients in Q1 2021. The ENHANCE phase 3 study results featured on November 16, 2020, in the late-breaking meeting of The Liver Meeting® 2020 backed by the American Association for the Study of Liver Diseases. This will be the fourth year running that seladelpar development program data in PBC features in an oral, late-breaking session at The Liver Meeting®.
CymaBay’s CEO and President, Sijal Shah, said that the company had made considerable progress towards the restart of the seladelpar development program with the RESPONSE study. The company targets completion of the late-stage seladelpar development program for PBC patients soon. Shah said that the ENHANCE study results presented at The Liver Meeting® 2020 show anti-cholestatic, anti-pruritic, and anti-inflammatory effects of seladelpar in patients with PBC. The CEO said that this highlights seladelpar’s potential of addressing vital unmet needs for PBC patients.
CymaBay commences ASSURE study
The company also commenced start-up activities for the ASSURE seladelpar study in PBC patients. The study intends to collect more safety data to support the registration, which will begin early next year. The first patients will be those that have been part of CymaBay’s previous seladelpar studies that include The ENHANCE trial. Patients who complete RESPONSE study and other future PBC studies for seladelpar have the option of enrolling in ASSURE.
Also, previously announced results from two different seladelpar studies in PBC patients and NASH will feature at The Liver Meeting® 2020. Recently the company announced a study evaluating MBX-2982’s potential in preventing hypoglycemia in Type 1 diabetes patients.