Australian biopharmaceutical company Immuron is proceeding with an Investigational New Drug (IND) submission following a productive meeting with the US Food and Drug Administration (FDA) for its drug candidate IMM-124E to treat Non-Alcoholic Steatohepatitis (NASH).
Based on this meeting with the FDA and in line with recent guidance, Immuron is preparing its Phase 2B protocol and expects to submit the full IND package to the FDA in the latter part of 2011. Subject to the final submission being agreed by the FDA, this will be followed by commencement of the approved clinical trial.
The trial is being designed by Immuron in conjunction with Dr Arun Sanyal, Professor of Medicine at Virginia Commonwealth University, who will serve as the principal investigator. The trial is a dose ranging placebo controlled, double blinded multi-centre study with sites in the USA, Israel and Australia. Enrolment is expected in the first half of 2012.
Principal investigator for Immuron’s Phase 2B trial, Professor Arun Sanyal stated “It is encouraging to see that a program with early promise using a novel approach to treating NASH is to be further investigated through a stringent phase 2B trial. I look forward to commencing this trial with the prospect of making Immuron’s NASH therapeutic available to patients in need.”
Immuron Chief Executive Mr Joe Baini said “This is a significant milestone for Immuron and more importantly for the millions of patients suffering from NASH, as it remains one of few life threatening diseases without an approved treatment.”
Date: August 22, 2011
Source: Immuron Limited www.immuron.com
Filed Under: Drug Discovery