ArTara advances trial of intestinal failure-associated liver disease therapy

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 in the release.

During the end-of-study meeting, ArTara reached an agreement with the FDA for the design of a phase 3 study to support a new drug application for intravenous choline chloride injection.

“For so many of these vulnerable patients who survive long-term on parenteral nutrition, IFALD and transplant is viewed as an inevitability,” Shefferman said in the release. “We are looking forward to continuing conversations with the FDA to make this potentially life-saving product available to the thousands of patients who rely on long-term parenteral nutrition and are in need of a treatment for IFALD.”

Reference: www.artaratx.com