FDA Lifts All Clinical Holds on Seladelpar
CymaBay Therapeutics has announced that the FDA has lifted clinical holds on its seladelpar Investigational New Drug Applications in NASH, PBC, and PSC. This allows the company to resume clinical development, focusing initially on Phase 3 trials for PBC. The development was halted in November 2019 due to atypical histological findings in a Phase 2 NASH study, but an independent review found no significant safety concerns. The move is viewed as a pivotal step forward for seladelpar, which has shown potential benefits in treating chronic liver diseases.
- FDA lifted clinical hold on seladelpar for NASH, PBC, and PSC, allowing trials to resume.
- Company plans to re-initiate Phase 3 clinical development focusing first on PBC.
- Independent expert panel confirmed the absence of significant liver injury related to seladelpar.
- Atypical histological findings were initially concerning, leading to a halt in trials.
Clinical hold lifted on seladelpar INDs in NASH, PBC and PSC
Re-initiating clinical development focusing first on Phase 3 for PBC
NEWARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today that the Food and Drug Administration (FDA) lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).
"This is a pivotal event for seladelpar, which had garnered a high degree of patient interest based on its promising potential for anti-cholestatic, anti-inflammatory and reduced symptom burden in patients with PBC. We are gratified and energized to be able to once again advance seladelpar into a registrational program to confirm its benefit. It is our unwavering goal to one day make it available to patients with PBC, and potentially for other chronic, inflammatory liver diseases,” said Sujal Shah, Chief Executive Officer of CymaBay. “We look forward to working with the medical and patient advocacy communities and with regulators to re-initiate development of seladelpar.”
On November 25, 2019, CymaBay halted all clinical trials of seladelpar after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end-of treatment biopsy review of a 52-week Phase 2 NASH study. The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold. CymaBay committed to an in-depth investigation of these findings and comprehensive safety evaluation that concluded with an independent, expert panel review involving some of the world’s leading liver pathologists and hepatologists. The expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study and unanimously supported re-initiating clinical development of seladelpar pending approval by the FDA. Based on the results of the investigation and the expert panel conclusions, FDA concluded that clinical trials for NASH, PBC and PSC may resume.
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. For additional information about CymaBay visit www.cymabay.com.
About Seladelpar
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases with the lead indication being PBC. For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA and PRIority MEdicine status from the EMA for PBC.
Cautionary Statements
The statements in this press release regarding CymaBay’s future plans and potential clinical development activities are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to the success, cost and timing of CymaBay's product development activities, including clinical trials. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
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LifeSci Advisors, LLC
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FAQ
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