In Friday’s after-hours trading, Immuron Limited (NASDAQ: IMRN) shares increased 21.21% to $2.40 as the pharmaceutical company submitted an application for a new medication.
Which document has IMRN filed?
This month, Immuron (IMRN) said that it has applied for an investigational new drug (IND) designation for Travelan with the US Food and Drug Administration. Immuron will assess the effectiveness of Travelan’s single-dose regimen in a Phase II clinical study utilizing a controlled human infection model (CHIM) and the enterotoxigenic Escherichia coli (ETEC) strain H10407. Up to 60 healthy adult volunteers are expected to participate in the clinical investigation. Each subject will be individually randomized to be given either a placebo (30 subjects) or a once-daily dosage of Travelan (1200 mg) (30 subjects).
The most typical ailment reported by tourists visiting underdeveloped nations and by US service members stationed abroad is infectious diarrhea. The morbidity and accompanying pain brought on by diarrhea reduce daily productivity, impair judgment, lower morale, and reduce operational preparedness. Antibiotic prescriptions are the first line of therapy for infectious diarrhea.
Sadly, during the past ten years, a number of gastrointestinal bacteria have developed increased resistance to widely used antibiotics. Additionally, the medical profession now acknowledges that travelers’ diarrhea can lead to post-infectious sequelae such as irritable bowel syndrome and various post-infectious autoimmune illnesses. For the US Military, developing a preventative therapy that guards against enteric illnesses is a top goal.
The clinical investigation will be carried out at the FDA-inspected clinical research facility in Baltimore, Maryland, in the United States, by the Contract Research Organization Pharmaron CPC, Inc, which is the sponsor of the IND. The Principal Investigator for the research will be Dr. Mohamed Al-Ibrahim, MB, ChB, FACP. Recruitment is anticipated to begin in the first half of 2023, pending FDA permission, and top-line findings from the clinical trial should be available by the year’s end of 2023.
IMRN invested strategically
Ateria Health Limited, a business established in the United Kingdom that has created a revolutionary solution for the treatment of irritable bowel syndrome, recently received a strategic investment from Immuron (IMRN) (IBS). Following the fulfillment of the prerequisites for the deal, which included completing Immuron confirmatory due diligence and receiving shareholder approval for Ateria, IMRN has finalized payment of the upfront cash investment of £1.5 million (paid from its existing cash reserves).