Australian microbiome biopharmaceutical company Immuron (ASX:IMC) has been granted final approval to commence its first in-human IMM-529 clinical study for the treatment of Clostridium Difficile Infection (CDI).
Approval was received from both the Hadassah Medical Center Ethics Committee as well as the Israeli Ministry of Health's (MoH) office.
Immuron's CDI clinical trial is designed to study a total of 60 patients diagnosed with CDI who have received standard of care antibiotic treatment. Patients will be enrolled within three weeks of their diagnosis and will be randomized into either IMM-529 three times daily, or placebo, for 28 days.
The primary objective of the study is to assess IMM-529's safety and tolerability, while secondary end points are to evaluate the preliminary efficacy of IMM-529 as evaluated by duration and severity of symptoms and rate of disease recurrence.
The study is to be conducted at Hadassah Medical Center in Jerusalem and is scheduled to be initiated within the next few weeks.
This is the Immuron's first human clinical study using IMM-529 followin positive results reported from a series of proof-of-concept pre-clinical efficacy studies completed by Dr Dena Lyras and her research team at Monash University.
The results from the Monash University study were recently published in the Nature Journal Scientific Reports in June 2017.
Dr Dan Peres, Immuron’s Chief Medical Officer, said, “The approval process conducted by both the Ethics Committee, and the Israeli Ministry of Health, demonstrates that the regulators deem our product’s safety profile favorably. We are excited to take the Monash University team’s extensive and successful results into human subjects to help these patients overcome CDI. IMM-529 offers a novel and safe solution to a growing problem and we hope this preliminary data will lead us to the next stage of the clinical development process."