Immuron (ASX:IMC, NASDAQ:IMRN) has been granted final approval to begin its first in-human, clinical study for the treatment of C.Difficile Infection (CDI).
CDI is a condition, acute especially in hospitals and in long-term in-patient care facilities due to bacterial toxin causing inflammation of the colon resulting in diarrhoea and in severe cases, death.
This is Immuron's first human clinical study using its IMM-529 product, following the results reported from a series of pre-clinical efficacy studies completed at Monash University.
IMM-529 is a naturally produced biological antibody product intended to prevent and treat CDI and designed to spare the gut microbiome from the effects of classic antibiotic treatments.
The new study is to be conducted at the Hadassah Medical Center in Jerusalem. Approval has been granted by the Hadassah Medical Center Ethics Committee and the Israeli Ministry of Health.
Immuron's clinical trial is designed to study a total of 60 patients diagnosed with CDI and have received standard of care antibiotic treatment.
Patients will be enrolled within three weeks of their diagnosis and will be randomised 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.
Immuron’s secondary endpoints are to evaluate the preliminary efficacy of IMM-529 as evaluated by the duration and severity of the symptoms and rate of disease recurrence.