CymaBay hopeful for seladelpar despite missing one trial endpoint

Sujal Shah
Sujal Shah

Interim data from an ongoing phase 2b trial of CymaBay’s seladelpar as a treatment for nonalcoholic steatohepatitis showed that the PPAR agonist did not reduce hepatic fat compared with placebo, but did show significant reductions in transaminase levels, according to Sujal Shah, president and CEO of the company.

At 12 weeks, alanine aminotransferase decreased by 25% to 37.5% in patients who received 10 mg or 15 mg of seladelpar and by approximately 32 U/L in those who received 50 mg. Similarly, gamma-glutamyl transferase decreased by 28% to 43% in the 10 mg and 15 mg groups.

“The marked changes in ALT suggests that the patient is getting healthier and that there’s a high chance of seeing this translate into NASH resolution when you look at histology,” Shah told Healio Gastroenterology and Liver Disease.

Shah noted that recent studies have shown that a decrease in ALT of 17 U/L or more is significantly correlated with NASH resolution.

“There are agents that don’t remove total fat that still have a benefit on histology,” Shah said. “What’s compelling with these data, thinking about it from that standpoint, is that this could have potential combined with another agent, such as a fat-burning agent.”

Additionally, all three doses were safe and well-tolerated at 12 weeks.

“We spoke to three independent hepatology thought leaders who told us that when we look at these biochemical changes, clearly there is a signal that liver health is improving in patients,” Shah said. “What that means and what the translation is to histology, we will see at 52 weeks, but clearly there is a benefit to patients in this study.”

CymaBay expects to have data from the end of the 52-week study in the first quarter of 2020. – by Talitha Bennett

Reference: www.cymabay.com

Disclosure: Shah is the president and CEO of CymaBay.

Sujal Shah
Sujal Shah

Interim data from an ongoing phase 2b trial of CymaBay’s seladelpar as a treatment for nonalcoholic steatohepatitis showed that the PPAR agonist did not reduce hepatic fat compared with placebo, but did show significant reductions in transaminase levels, according to Sujal Shah, president and CEO of the company.

At 12 weeks, alanine aminotransferase decreased by 25% to 37.5% in patients who received 10 mg or 15 mg of seladelpar and by approximately 32 U/L in those who received 50 mg. Similarly, gamma-glutamyl transferase decreased by 28% to 43% in the 10 mg and 15 mg groups.

“The marked changes in ALT suggests that the patient is getting healthier and that there’s a high chance of seeing this translate into NASH resolution when you look at histology,” Shah told Healio Gastroenterology and Liver Disease.

Shah noted that recent studies have shown that a decrease in ALT of 17 U/L or more is significantly correlated with NASH resolution.

“There are agents that don’t remove total fat that still have a benefit on histology,” Shah said. “What’s compelling with these data, thinking about it from that standpoint, is that this could have potential combined with another agent, such as a fat-burning agent.”

Additionally, all three doses were safe and well-tolerated at 12 weeks.

“We spoke to three independent hepatology thought leaders who told us that when we look at these biochemical changes, clearly there is a signal that liver health is improving in patients,” Shah said. “What that means and what the translation is to histology, we will see at 52 weeks, but clearly there is a benefit to patients in this study.”

CymaBay expects to have data from the end of the 52-week study in the first quarter of 2020. – by Talitha Bennett

Reference: www.cymabay.com

Disclosure: Shah is the president and CEO of CymaBay.