January 31, 2018 – Immuron (ASX:IMC) (NASDQ:IMRN), an Australian microbiome biopharmaceutical company focused on developing and commercializing oral immune-therapeutics for the treatment of gut mediated diseases, started at the begining of the year the enrollment of the first patients into the first-in-human IMM-529 clinical study for the treatment of Clostridium Difficile Infection (CDI) at Hadassah Medical Center in Jerusalem. This clinical study is being led by Professor Yoseph Caraco, head of the Clinical Pharmacology Unit at Hadassah Medical Center in Jerusalem. It is the Company’s first in-human clinical study using IMM-529 for the treatment of CDI, as its previous pre-clinical efficacy studies completed by Dr. Dena Lyras and her research team at Monash University showed significant potential in all disease phases. Topline results are anticipated in the first quarter of 2019.
Most commonly affecting older adults after use of antibiotic medications, CDI can cause symptoms that range from diarrhea to life-threatening gut inflammation.
The Immuron CDI clinical study is a Phase I/II placebo-controlled study focusing on the safety, tolerability, and preliminary efficacy of IMM-529. Preliminary efficacy will be assessed by duration and severity of symptoms, as well as the rate of disease recurrence when compared to administered placebo. A total of 60 confirmed CDI patients will be randomized to receive either IMM-529 or a placebo three times a day for a total of 28 days. Patients will then be monitored for two additional months to determine any recurrence of disease.
Immuron’s proposed approach of targeting the main virulence factors of the disease with only a minor disturbance to the natural microbiome would potentially be extremely valuable in treating CDI. In view of the preclinical work performed on IMM-529, I am optimistic that IMM-529‘s mechanism of action might be the answer we’re all looking for.”
According to the Centers for Disease Control and Prevention (CDC) 1, Clostridium-difficile infects more than 450,000 patients causing over 29,000 deaths per year in the United States alone. There is a high likelihood for recurrence of symptoms, which nearly triples the healthcare costs per patient, resulting in annual healthcare costs of nearly $4.5 billion. The CDC also cites the importance of developing new treatments including the need for improved antibiotic use and infection control.
IMM-529 uses a combination of polyclonal antibodies to target and neutralize the three main virulence factors of CDI without negatively impacting the microbiome. The drug is unique in that it targets the spores and vegetative cells that are thought to be the primary cause of the recurrences, alongside the Toxin B which is targeted by most therapeutics in development today. The compound, which is delivered orally three times a day, provides a solution that is easily tolerable to patients to treat and prevent recurrence of CDI.
Immuron’s Chief Medical Officer Dr. Dan Peres commented: “We are excited to enrol our first patients into the IMM-529 study, a drug that has shown promise in successfully treating Clostridium-difficile. Our technology’s unique delivery of antibodies clearly differentiates it from other Clostridium-difficile treatments on the market or in development.
We believe the results of this approach, as already reflected in our pre-clinical studies, will continue to garner attention from the pharmaceutical industry and the medical community. We look forward to the top line results in the beginning of 2019.”