Axcella announced clearance of the company’s first investigational new drug (IND) filing and provided an update on its product candidates, research and development activities and expected milestones for 2021. AXA1665 Program Update: - Axcella announced that its IND application has been cleared by the U.S. Food and Drug Administration (FDA) for AXA1665, the company’s oral product candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE). In the second quarter of 2021, Axcella plans to initiate a Phase 2 trial of AXA1665. The Phase 2 trial will be a randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of AXA1665 in patients who have experienced at least one prior OHE event and have neurocognitive dysfunction at screening. Approximately 150 patients on either lactulose ± rifaximin (stratified by rifaximin use) will be enrolled and randomized 1:1 to receive either 53.8 grams per day of AXA1665 or a calorie-matched placebo in three divided doses for 24 weeks, with a two-week safety follow-up period. The trial will be conducted globally with the primary endpoint assessing change in the psychometric hepatic encephalopathy score (PHES) after 24 weeks of treatment. Secondary endpoints will include the proportion of patients experiencing an OHE breakthrough event; time to first OHE breakthrough event, including time to hospitalization; changes in physical function; and patient-reported outcomes. Other endpoints include measures of circulating ammonia, amino acids, and inflammation-related markers.