Immuron (ASX:IMC) has announced that its IMM-124E Phase 2 clinical trial for the treatment of NASH (Non-Alcoholic Steatohepatitis) has reached its 50 per cent recruitment milestone with 56 patients having been successfully randomised and an additional 4 patients to be randomised this week.
To date, 25 patients have successfully completed treatment.
The company also announced that no significant treatment adverse events have been reported.
Patients who qualify for the clinical trial are randomised into 3 groups who receive either; a 600 mg or 1,200 mg dose of IMM-124E, or placebo, three times daily.
Immuron said it expects recruitment to be finalised during the second half of 2016. It now has a total of 28 active clinical study sites across the US, Australia and Israel, including 4 additional sites initiated since January.
It has also targeted 2 additional sites in the US, which is on track to commence enrolment in June 2016.
“This is a significant milestone for the company, and a great achievement by the team. We continue to work with our study sites to find ways to accelerate recruitment," said Dan Peres, Immuron’s Head of Medical. "IMM-124E has several advantages over our competitors including a great safety profile which provides a compelling option for our PIs and their patients.”
Immuron announced the launch of the NASH Phase 2 multinational multi-centre randomised double blind placebo controlled study of its proprietary compound IMM-124E for the treatment of NASH in December 2014, with the first patient randomised in February 2016.
The protocol was developed by Immuron in partnership with its Scientific Advisory Board led by Professor Arun Sanyal of Virginia Commonwealth University (US).