Axcella (NASDAQ: AXLA) has announced the activation of initial clinical study sites and patient screening for the global phase 2 clinical study of AXA1665. AXA1665 is Axcella’s multi-target oral drug candidate for reducing the risk of recurrent overt hepatic encephalopathy.
OHE is a severe condition with a devastating impact
Andres Duarte-Rojo, the principal study investigator, said, “OHE is a condition that has devastating consequences for patients and families and places a substantial economic burden on the overall healthcare system. Given the limitations of today’s standards of care and the lack of clinical development activity beyond ammonia-focused agents, it also is an area in dire need of medical innovation. AXA1665 has demonstrated the potential to have a multifactorial benefit to patients in prior clinical studies, including improvements in amino acid balancing, ammonia metabolism, muscle function, and neurocognition.
Based on AXA1665’s potential to help physicians, patients, and other care providers overcome severe problems related to cirrhosis and OHE, Axcella has dubbed the Phase 2 trial EMMPOWER. The company will evaluate the safety and efficacy of AXA1665 in patients who have had at least one previous OHE episode and exhibit neurocognitive impairment at a screening in this double-blind, randomized, placebo-controlled, multi-center study. The study will randomize 150 lactulose rifaximin patients in a 1:1 ratio to receive 53.8g of AXA1665 or placebo in three different doses for 24 weeks, followed by a safety follow-up period of four weeks.
EMMPOWER to take place in 70 clinical sites
Axcella CEO Bill Hinshaw said, “The initiation of EMMPOWER is an important milestone, ushering in an exciting new era of clinical development for Axcella as we seek to tackle a variety of complex diseases utilizing proprietary, multi-targeted EMM compositions.”
The company will conduct EMMPOWER study in over 70 clinical sites with the primary goal of assessing the percentage of patients with more than 2 point increase in psychometric hepatic encephalopathy score after 24 weeks.