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Coronavirus tracker: Amgen, Genfit say they’re not expecting ‘significant’ trial delays, though others might

Amgen said it doesn’t expect any “significant delays” to the clinical development of its highly anticipated KRAS lung cancer drug—nor does Genfit with its NASH candidate. However, Akero Therapeutics said it’s about halfway through collecting biopsies for its own NASH drug, and it isn’t clear at the moment how much COVID-19 will interfere.

Meanwhile, the FDA and the FTC are sifting through social media posts and online ads for fraudulent coronavirus therapies—and have delivered stern warnings to websites offering “infection prevention nasal spray” or herbal remedies and cures.

As of Tuesday, the number of global confirmed cases has surpassed 838,000, according to Johns Hopkins University’s real-time dashboard, and more than 41,250 people have died.

Amgen said it doesn’t expect to see any “significant delays” to the development of its highly anticipated KRAS cancer drug, AMG 510, due to the spreading pandemic. The Big Pharma said its potentially pivotal phase 2 study is already fully enrolled with lung cancer patients. 

Genfit told its investors the same regarding the upcoming unblinding of its phase 3 elafibranor study in nonalcoholic steatohepatitis, or NASH. The company doesn’t “currently anticipate” that COVID-19 will delay its results; however, Genfit has already pushed back the release since its February database lock to gather feedback from the FDA. 

Akero Therapeutics, however, may not be so lucky. It planned to report top-line phase 2a NASH data from its drug AKR-001 in the second quarter—but it is currently about halfway through collecting biopsies. “The extent to which the COVID-19 pandemic will interfere with collection of the remaining biopsies and data from other scheduled clinical visits, including the safety follow-up visit at week 20, is unclear,” the company said.