Why Micro-Cap Biopharma Axcella Health Is Surging Higher

Axcella Health Inc AXLA shares were soaring Wednesday following a clinical readout from the company.

The Cambridge, Massachusetts-based company announced positive top-line data from a study dubbed AXA1125-003, showing multifactorial activity in adults with non-alcoholic fatty liver disease, or NAFLD.

The study assessed the impact of two product candidates — AXA1125 and AXA1957 — on safety, tolerability and effects on structures and functions of the liver, as measured by a comprehensive panel of imaging and soluble biomarkers related to metabolism, inflammation and fibrosis.

In the non-IND study, 102 adult NAFLD patients with presumed non-alcoholic steatohepatitis, or NASH, were enrolled in a 2:2:2:1 ration to receive AXA1125, or one of the AXA1957 doses or placebo, administered twice daily for 16 weeks.

Results from the study showed that AXA1125 produced larger and more consistent reductions in clinically relevant biomarkers than AXA1957. Among the 11 study participants with Type 2 diabetes receiving AXA1125, a greater proportion achieved each of the specified thresholds.

With the achievement of clinically relevant reductions in liver fat content, insulin resistance and fibroinflammation markers, and the favorable tolerability, AXA1125 is likely to emerge as a first-line NASH therapy, according to Axcella. 

"Given the strength and consistency of data on AXA1125, we have selected it as our product candidate for NASH and have decided that we will not reinitiate our AXA1957-002 pediatric study, which had recently been suspended due to COVID-19," CEO Bill Hinshaw said in a statement. 

The company said it plans to engage with FDA regarding IND submission for AXA1125, as well as a proposed Phase 2b clinical trial in adult NASH and pediatric development program.

Axcella shares were trading 29.42% higher at $6.29 at the time of publication Wednesday. 

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