Dual-listed biopharmaceutical company Immuron (ASX: IMC) is on course to make progress with a new oral therapeutic to treat campylobacteriosis and E. coli infections after development partner Naval Medical Research Center (NMRC) requested a pre-IND meeting with the US Food and Drug administration (FDA).
Immuron and the NMRC could potentially see developmental progress made, despite the crushing effects of the COVID-19 pandemic that continue to restrict all activity in all sectors of the economy.
The emergence of the pandemic, combined with consequent containment measures imposed by governments worldwide, has forced the FDA to prioritise its formal meetings and application reviews in an order of importance, focusing primarily on submissions related to COVID-19 and other life-threatening conditions.
Amid the turmoil, Immuron intends to develop a novel means of treating E. coli infections, as a supplement to its existing production of Travelan, an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting Travellers’ diarrhoea – a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce.
Preparing for development
According to the Immuron, it expects the FDA to provide written comments on the non-clinical information in the pre-IND information package which is planned to be submitted on 10 June 2020.
Following the FDA’s response and having considered the agency’s guidance and feedback, Immuron said the NMRC will file an investigational new drug application “later this year” and commence phase 2 clinical studies “during the first half of 2021”.
One trial is expected to focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis while a second trial evaluates E. coli infections.
“We received a formal start work notification and approval at the end of January 2020 from the Henry Jackson Foundation for the Advancement of Military Medicine to commence work on the sub award,” said Dr Jerry Kanellos, chief executive officer of Immuron.
The biopharma company was in position to commence its leading project with all necessary permits secured to obtain the necessary vaccines, and all study components shipped to relevant contract research partners – until the COVID-19 pandemic brought activity to a standstill.
The COVID-19 pandemic put the brakes on this and all our research and development activities,” said Dr Kanellos.
“We have been monitoring the situation closely and I am please to say with the easing of restrictions around Australia work on the development of the clinical product can now recommence. The plan is to have the product completed by the end of this year and have it ready for clinical evaluation next year,” he said.
Problematic development as a result of COVID-19 doesn’t stop there for Immuron. The company has also admitted that the pandemic has also impacted its IMM-124E paediatric clinical study in non-alcoholic fatty liver disease.
According to Immuron, the study’s principle investigator Dr Miriam Vos from the Emory University School of Medicine closed the trial earlier this year with only 22 subjects out of 40 completing the study protocol.
The findings were reported as “negative” given the lack of substantial changes in the primary study end point in the active arm of the study when compared to a placebo.