Immuron, using its proprietary technology, has initiated the following R&D path for multiple applications:
1. Nonalcoholic Steatohepatitis (NASH):
Based on its previous clinical data the company initiated - A Phase II, multicenter, double blind randomized clinical study in the USA, Australia and Israel. The study's goal is to assess the safety and effectiveness of IMM-124E for the treatment of NASH. A total of 120 NASH patients are now enrolled in the study, comparing 2 doses of IMM-124E to placebo for a 6 months period. The study design had been reviewed by the FDA and finalized under the agencies recommendation. The study is expected to end by Q1 2018.
2. Alcoholic SteatoHepatits (ASH):
Immuron's platform had been identified and chosen by the leading research group within the NIH to have the potential to treat this disease, which is of high importance currently. The NASH CRN, led by the former president of the AASLD, prof. Arun Sanyal, is currently conducting a randomized placebo control study on 66 ASH patients in the USA. The study is expected to generate safety as well as preliminary efficacy data and should be completed by Q1 2019.
3. Pedriatric Nonalcoholic Fatty Liver:
This National Institute of Health funded aclinical study is currently being performed by the Emory University and is evaluating the safety and efficacy of IMM-124E in 40 patients. Topline results are expected Q4 2018.
Based on previous phase 1 clinical data, the company decided to move forward and develop a phase 2 study protocol to submit to the FDA intended for a New Drug Application (NDA).
5. Clostridium Difficile (C. diff):
Immuron joined hands with the Monash University in Melbourne to develop a unique product - the IMM-529 - for prevention and treatment of C. diff infections. The collaboration has generated promising data and the company initiated a phase 2 study in 60 patients with CDI in Q4 2017.
Immuron conducted animal studies with a variety of Colitis models and is moving forward with leading key opinion leaders to continue development.
7. Uropathogenic Escherichia Coli (UPEC):
Pre Clinical work has begun at Monash University using a novel Hyper immune anti-UPEC product produced by Immuron to treat one of the most common diseases, Urinary Tract Infections.