After receiving crucial regulatory permission, Immuron Limited (Nasdaq: IMRN) has increased 32.95% to $2.30 in pre-market trading hours on the most recent Friday.
Which endorsement does IMRN have?
The US Food and Drug Administration has given Immuron (IMRN) the go-ahead to continue with the clinical assessment of Travelan, the company stated today. It is now active for Immuron’s Investigational New Drug (IND) application to assess the effectiveness of a single dosage of Travelan to treat infectious diarrhea brought on by ETEC.
IMRN will move on with the anticipated clinical study in the United States in light of this approval. A designed and controlled infection-model investigational design will be used to evaluate the security and protective effectiveness of Travelan.
The enterotoxigenic Escherichia coli (ETEC) strain H10407 will be used in Phase II clinical study to assess the effectiveness of a monotherapy schedule of Travelan in a controlled human infection model (CHIM). Up to 60 healthy adult volunteers will be enrolled in the clinical investigation, and each will be randomly allocated to receive either a placebo (30 subjects) or a once-daily dosage of Travelan (1200 mg) (30 subjects).
The clinical investigation will be carried out by the Contract Research Organization Pharmaron CPC, Inc at its FDA-inspected clinical research facility in Baltimore, Maryland in the United States, IMRN is the IND’s sponsor. The clinical trial’s main findings are anticipated to be released by year’s end in 2023, with recruitment set to start in the first half of 2023.
IMRN made a strategic move
Immuron (IMRN) secured a strategic investment in Ateria Health Limited, a business based in the United Kingdom that has created a game-changing solution for the treatment of irritable bowel syndrome (IBS). Following the fulfillment of the pre-transactional requirements, comprising execution of Immuron confirmatory due diligence and shareholder approval for the transaction, Immuron (IMRN) has finalized payment of the upfront financial investment of £1.5 million (paid from IMRN’s existing cash reserves).