A little over a year after resurrecting the liver disease drug seladelpar, CymaBay Therapeutics now has $100 million to bankroll a phase 3 study of the drug.
The biopharmaceutical company picked up the non-dilutive financing from Abingworth on Monday to fund trials for seladelpar, including a phase 3 trial and an open-label extension trial. The life sciences investor will give CymaBay $75 million in three installments over six months. Within two months of completing enrollment in the phase 3 trial called Response, the company has the option to get the remaining $25 million.
CymaBay will make fixed payments throughout the six years after first obtaining regulatory approval, either in the U.S. or the EU. CymaBay is also responsible for paying fixed and capped sales milestones on U.S. product sales. The biopharma will retain worldwide commercial rights to seladelpar.
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In November, the Newark, California-based biopharma presented data showing seladelpar beat placebo at lowering a liver enzyme in patients with primary biliary cholangitis (PBC). The rare, progressive disease can lead to inflammation and scarring in the liver. That data led CymaBay to move forward with a phase 3 study in the first quarter of 2021.
The move came after development of seladelpar was cut short in 2019 when signs of liver damage were found in some patient biopsies in a separate phase 2 study. The biopsies showed liver damage, but liver enzyme levels and other measures did not.
An independent panel of hepatologists and liver pathologists later supported the re-initiation of development for the therapy. CymaBay had hoped to develop it for primary sclerosing cholangitis and nonalcoholic steatohepatitis and PBC.
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CymaBay is moving forward with seladelpar in PBC. The phase 3 Response trial is a 52-week global study with approximately 180 patients randomized to the drug or placebo. Patients are still being dosed.