CymaBay Therapeutics Announces Oral Late-Breaking Presentation of Positive Results from the ENHANCE Global Phase 3 Study Evaluating Seladelpar for Primary Biliary Cholangitis at The Liver Meeting® 2020
NEWARK, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced an oral late-breaking presentation of the positive results from the ENHANCE phase 3 study evaluating seladelpar for primary biliary cholangitis (PBC). These data were presented online today during the late-breaking session at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD).
In an oral presentation titled, “ENHANCE: Safety and efficacy of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) – A Phase 3, International, Randomized, Placebo-Controlled Study,” Professor Gideon Hirschfield, FRCP PhD, Lily and Terry Horner Chair in Autoimmune Liver Disease at the University of Toronto, presented results from ENHANCE, a phase 3 study of seladelpar in patients with PBC. Eligible PBC patients with either an inadequate response, defined as alkaline phosphatase (ALP) greater than or equal to 1.67 times the upper limit of normal (ULN), or intolerance to ursodeoxycholic acid (UDCA) were randomized to daily seladelpar 5 or 10 mg or placebo (pbo). The primary endpoint was a composite response of ALP <1.67x ULN, ALP decrease =15% and total bilirubin (TB) =ULN at Month 12. Secondary endpoints were ALP normalization at Month 12 and change in pruritus numerical rating scale (NRS) at Month 6. Due to the early termination of the study and the small number of patients who had reached the 52 week timepoint, the primary outcome measure was amended prior to database lock to a 3 month timepoint. After only 3 months, 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome (p<0.0001). In addition, 27.3% of patients on seladelpar 10 mg versus zero on placebo experienced normalization of ALP by 3 months (p<0.0001). Treatment with seladelpar 10 mg also resulted in a statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch at baseline versus placebo. Additional data highlighted the sustained anti-cholestatic, anti-inflammatory, and anti-pruritic effects of seladelpar through six months. Overall, seladelpar appeared to be safe and well-tolerated in this study. The only AE in >10% of patients was pruritus in 12.6%, 3.4%, and 11.2% in the pbo, 5 and 10 mg groups, respectively. There were no treatment-related serious adverse events and 2 treatment-emergent AEs led to study discontinuation.
”These findings suggest that seladelpar treatment is well positioned to be a preferred second line treatment for patients with PBC,” said Professor Hirschfield. “Data from this study show that seladelpar appears efficacious, safe, and well-tolerated. Given the high unmet need that exists in the PBC population, I believe investigators and patients will continue to support CymaBay’s efforts to make this breakthrough therapy available to patients.”
A second clinical presentation titled, “A 52-Week Multi-Center Double-Blind Randomized Phase 2 Study of Seladelpar, a potent and selective peroxisome prliferator-activated receptor delta (PPAR-delta) agonist, in Patients with Nonalcoholic Steatohepatitis (NASH),” was presented by Dr. Stephen A. Harrison, MD, Medical Director of Pinnacle Clinical Research. This electronic poster presentation was selected by AASLD for special recognition as a “Poster of Distinction” and highlighted the effects of seladelpar on liver fat, liver enzymes, and key histologic endpoints recognized by regulators for registration, including NASH resolution and reduction in fibrosis.
Sujal Shah, CEO of CymaBay Therapeutics, commented, “The results from the ENHANCE study provide encouraging evidence of the anti-cholestatic, anti-inflammatory and anti-pruritic effects of seladelpar in patients with PBC. We look forward to further collaboration with the medical community as we anticipate the initiation of our RESPONSE global Phase 3 registration study. In addition to our core focus in PBC, we continue to explore how this novel PPARd agonist can advance care and target other indications with high unmet needs.”
CymaBay’s presentations from The Liver Meeting® 2020 can be found at: https://ir.cymabay.com/presentations.
For additional information about CymaBay visit www.cymabay.com.
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