ArTara Therapeutics has completed an end-of-phase 2 meeting with the FDA to discuss a phase 3 study of intravenous choline chloride substrate replacement for patients with intestinal failure-associated liver disease, according to a press release.
Results from the phase 2 randomized control study met its two objectives for intestinal failure-associated liver disease (IFALD): steatosis reversal and improvement in cholestasis.
“When left untreated, these pathologies combine in IFALD patients to cause steady progression to end-stage liver disease,” Jesse Shefferman, CEO of ArTara, said

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