Australian-based and globally integrated biopharmaceutical company Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has filed a pre-IND (investigational new drug) application with the US Food and Drug Administration (FDA) for IMM-529.
CEO Steven Lydeamore said, “We are excited for our third therapeutic to be heading towards Phase 2 clinical studies, demonstrating the utility of our technology platform.”
Rise of superbugs
The increased incidence of antibiotic-resistant superbugs has amplified the use of broad-spectrum antibiotics worldwide – this, in turn, has disrupted gastrointestinal microbiota, making patients susceptible to opportunistic pathogens like Clostridioides difficile.
Clostridioides difficile is the most common pathogen in healthcare-associated infections and was deemed an urgent threat by the Centers for Disease Control and Prevention’s 2019 report on antibiotic resistance threats.
The treatment of Clostridioides difficile infection (CDI) involves antibiotics, which prevent the regeneration of gut flora and predispose patients to relapse.
CDI affects more than 400,000 people in the US annually, contributing to in excess of 30,000 deaths.
To address this critical health threat, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard-of-care antibiotics for the prevention and treatment of recurrent CDI.
Return of normal gut flora
IMM-529 antibodies targeting the pathogen may help clear the infection and promote quicker re-establishment of normal gut flora, offering an attractive oral preventative for recurrent CDI.
Immuron is collaborating with Dr Dena Lyras and her team at Monash University, Australia, to develop vaccines producing bovine colostrum-derived antibodies.
Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) containing antibodies targeting three essential Clostridioides difficile virulence components.
IMM-529 targets Toxin B, the spores and the surface layer proteins of the vegetative cells. This unique three-target approach has shown promising results in pre-clinical infection and relapse models.
Efficacy has been demonstrated in all three phases of the disease - prevention of primary disease (80% effectiveness, P = 0.0052), protection against disease recurrence (67%, P
Importantly, IMM-529 antibodies cross-react with whole cell lysates of many different human strains of the pathogen, including hypervirulent strains.
Opportunity assessment by Lumanity indicates that, if effective, IMM-529 could be positioned early in the treatment algorithm.
It could be used at the second recurrence, after one course each of fidaxomicin and vancomycin, or even earlier for high-risk patients.
Strong projected yearly revenue
Around 31,000 patients would be eligible if IMM-529 is positioned at the second recurrence and up to 95,000 patients would be eligible if positioned at the first recurrence.
The projected yearly revenue for IMM-529 is US$93 million with the potential to increase significantly if used earlier in the treatment process.
Infectious disease experts view the oral dosing of IMM-529 as a positive step, particularly given the complexity and expense of current advanced CDI treatments.