Benzinga | Jan 6, 2022 07:58AM EST

Axcella Therapeutics Details Clinical And Operational Milestones For 2022

* Long COVID Phase 2a top-line data anticipated in mid-2022

* EMMPACT Phase 2b interim data in nonalcoholic steatohepatitis (NASH) anticipated in mid-2022

Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today outlined key clinical and operational milestones that are expected for the company in 2022.

"The year 2021 was a foundational time for Axcella Therapeutics that was highlighted by the clearance of our first investigational new drug (IND) filings and the initiation of three Phase 2 clinical trials," said Axcella President and Chief Executive Officer Bill Hinshaw. "These accomplishments set the stage for what we expect to be an exciting and transformative 2022 as we continue to enhance our platform, build on our science and leverage important new clinical insights for additional potential applications. With patient screening well underway in our Long COVID Phase 2a trial, we remain at the forefront of the therapeutic development landscape for this debilitating condition and are on track for a top-line data readout mid-year. Shortly thereafter, we plan to conduct an interim analysis from our EMMPACT Phase 2b clinical trial that will provide the most robust data to date about AXA1125's potential in NASH."

AXA1125 for Long COVID

AXA1125, a multi-targeted oral EMM composition that has shown the potential to improve mitochondrial energetics and reduce inflammation, is being investigated in a Phase 2a clinical trial enrolling approximately 40 patients with Long COVID. In 2022, Axcella expects to:

* Complete enrollment in the Phase 2a trial (first half of 2022);

* Report top-line data (mid-2022);

* Assuming positive data, engage with regulatory authorities to discuss the potential for a registrational clinical trial of AXA1125 in Long COVID; and

* Assuming positive data, consider AXA1125's potential to address mitochondrial dysfunction in conditions other than Long COVID.

AXA1125 for NASH

In past clinical studies, AXA1125 has demonstrated its potential to reduce well-established markers of liver fat, inflammation and fibrosis. This candidate is currently being investigated in the EMMPACT Phase 2b clinical trial enrolling approximately 270 patients with biopsy-confirmed F2/F3 NASH. In 2022, Axcella expects to:

* Report interim data (mid-2022); and

* Complete patient enrollment in EMMPACT.

AXA1665 for OHE

AXA1665 is a multi-targeted oral EMM composition that has shown the potential to improve amino acid balance, ammonia metabolism, muscle function and neurocognition in past clinical studies. This candidate is currently being investigated in the EMMPOWER Phase 2 clinical trial enrolling approximately 150 patients with a history of overt hepatic encephalopathy (OHE). In 2022, Axcella expects to:

* Provide an enrollment update for EMMPOWER.

About Axcella Therapeutics (NASDAQ:AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.