Axcella to begin EMMPOWER℠ Phase 2 clinical trial of OHE drug, AXA1665

Axcella Health Inc., a biotechnology company that uses endogenous metabolic modulator (EMM) formulations to treat complicated disorders, has recently started the initial clinical sites and patient screening for its global Phase 2 clinical trial of multi-targeted oral drug AXA1665, formulated to treat recurrent OHE (overt hepatic encephalopathy).

The company claims that the phase 2 trial EMMPOWER is branded based on the potential of AXA1665 to assist physicians, patients, and other caregivers to overcome severe problems associated with cirrhosis and OHE.

In this randomized, placebo-controlled, double-blind, multicenter study, the efficacy and safety of AXA1665 will be evaluated in patients who have had at least one prior OHE incident and had neurocognitive dysfunction during screening.

A total of 150 patients on lactulose rifaximin (segmented by rifaximin use) will be treated with a calorie-matched placebo in three divided doses for 24 weeks, with a follow-up safety period of four weeks or 1:1 to receive 53.8 grams per day of AXA1665.

According to Andres Duarte-Rojo, M.D., M.S., Ph.D., Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, and the trial’s principal investigator, OHE is a disease that has serious consequences for patients and their families, as well as a significant financial burden on the healthcare system.

He said that owing to the present situation like standards of care and absence of clinical expansion activity beyond ammonia-focused agents, It is also an area in desperate need of medical innovation.

AXA1665 has demonstrated to offer diverse benefits to patients, including improvements in amino acid balancing, ammonia metabolism, muscular function, and neurocognition in previous clinical studies. He added that they are looking forward to see if AXA1665 can reproduce these results and reduce OHE incidents in EMMPOWER.

President and CEO of Axcella, Bill Hinshaw, said that the start of EMMPOWER is a significant milestone for Axcella as they attempt to address a wide range of complicated diseases utilizing multi-targeted, proprietary EMM compositions.

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