Clostridioides Difficile Infection (CDI) is an infection of the colon caused by the bacteria Clostridioides difficile that produces toxins that cause inflammation and severe diarrhea. CDI can also result in serious disease complications including bowel perforation, toxic megacolon, and sepsis, and it can prove fatal in the most severe cases. In recent years, increases in the frequency and severity of CDI have been observed worldwide, as well as an increased risk of community-associated CDI, and CDI in persons previously thought to be low risk. It is estimated that CDI affects up to 1.2% of hospitalized patients in the United States, representing an estimated cost of USD 4.8 billion per year.  In Europe, the estimated cost is approximately 3 billion per year, which is likely to increase concomitantly with a more elderly society; more than 134 million Europeans will be >65 years by 2050. In addition to hospitalization, the most significant predisposing factors for CDI include advanced age (>65 years) and antibiotic therapy (disrupts the normal gut microbiota). The most common antibiotics implicated to date include broad-spectrum cephalosporins, fluoroquinolones and clindamycin. The only remaining effective therapeutic agents are metronidazole, vancomycin and fidaxomicin. Vancomycin and metronidazole are the current standard of care, accounting for 50% of patients’ care in the US. However, these two therapies are plagued by a 25% rate of CDI recurrences and each recurrence predisposes to further recurrence. After two or more episodes of recurrence, the risk of subsequent recurrence may reach 65%. This underscores the need for new treatments. Against this backdrop, the last decade has seen the emergence of a new epidemic of CDI characterized by increased frequency and severity of enteric disease and increased resistance to antibiotic therapy.

Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It is anticipated that first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to ~98k patients would be eligible if IMM-529 is positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue in the United States for IMM-529 is projected at US$400M. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts.

Partnering to progress Clinical Trials

Immuron has engaged Pullan Consulting to provide business development services to assist in securing a strategic partnership for IMM-529.

Immuron has U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application (IND 32095) for clinical development of IMM-529 as a product to     specifically prevent or treat Clostridioides difficile infection (CDI) in a Phase 2 clinical trial.

IMM-529 has a validated biological target. FDA-approved monoclonal antibody Bezlotoxumab was developed as a first‑in‑class therapy designed to prevent recurrence of Clostridioides     difficile infection (CDI) by neutralizing toxin B, the major driver of recurrent disease. IMM-529’s polyclonal antibodies offer multivalent defense compared with monoclonal single-epitope     antibodies (Bezlotoxumab). IMM-529 also has an advantage over current standard of care antibiotic treatments that disrupt microbiota. IMM-529 decolonizes the gut facilitating clearance    of the pathogen, recovery of the microbiome and prevention of recurrent infection.

Immuron has completed an Investigational Brochure and clinical protocol and has secured a principal investigator and three Australian sites. This trial is eligible for Australia’s Clinical     Trial Notification (CTN) scheme, a fast-track method for initiating trials.1 Immuron has manufactured and released drug product for supply of a clinical trial.

The trial protocol is for a randomized, double blind, placebo-controlled clinical study of IMM-529 with Standard of Care (SOC) for the treatment of CDI in subjects with first episode CDI or     recurrent CDI. Up to 60 subjects will be enrolled in the study. Subjects would be randomly assigned to IMM-529 + SOC or placebo + SOC in a 2:1 ratio at multiple sites. The primary           objective would be to evaluate the safety and tolerability of IMM-529 together with SOC in patients with CDI or recurrent CDI. Determination of efficacy would be assessed by the measurement and comparison of mortality rate, disease symptoms and recurrence rate for each treatment group.