Immuron Ltd (ASX:IMC, NASDAQ:IMRN) has concluded the phase II study of IMM‐124E for the treatment of NASH (non-alcoholic steatohepatitis), with the results expected in Q1 2018.
NASH is also known as non-alcoholic fatty liver disease.
The last patient in the clinical study conducted the final scheduled visit on October 9, following a 28‐week study period. The study enrolled a total of 133 patients with biopsy‐proven NASH.
On October 18, the study site conducted its close‐out visit.
This effectively concludes patient dosing and research activities at all study sites for the Phase II study.
Immuron will report its top line clinical trial results in Q1 of calendar year 2018, once all data is finalised and reviewed by the company and its scientific advisory board.
Once reported, Immuron will continue its partnering and business development efforts to reach the next phase of clinical studies.
In July 2017, the company revealed interim analysis results, in which IMM‐124 demonstrated a statistically‐significant reduction in two enzymes found in the liver, compared to the placebo.
These preliminary results suggested a reduction in liver injury over the duration of treatment compared to the placebo.