The Immuron Limited (ASX: IMC) share price is up by 6.86% on news that the U.S. Food and Drug administration (FDA) has provided guidance in relation to the clinical development pathway for its new oral therapeutics.
The oral therapeutics are being developed to treat campylobacteriosis and E. coli (ETEC) infections. The Immuron share price was trading over 11% higher following the release, before retreating to its current level of 24 cents per share.
What does Immuron do?
Immuron is an Australian biopharmaceutical company that focuses on developing and commercialising orally delivered antibodies, used in the treatment of inflammatory and infectious diseases.
Immuron has a novel and safe technology platform with one current drug generating revenue, Trevelan. Trevelan reduces the risk of traveller's diarrhea and minor gastro-intestinal disorders, and is antimicrobial. It is licensed in Australia, Canada and sold as a dietary supplement in the US.
What caused the Immuron share price to jump?
The Immuron share price jumped after the company released news it had received written guidance for its new investigational drug. The FDA review provided a written response to the non-clinical questions posed in its briefing documentation submitted in early June. The FDA also provided additional guidance and comments to support the new drug submission.
There are set to be two human phase II clinical trials for the company's oral therapeutics, to be conducted in 2021. One trial will focus on the ability of the hyperimmune product to protect volunteers against campylobacteriosis. The other trial will focus on ETEC infections.
Immuron CEO Dr. Jerry Kanellos commented: "This is an important milestone in the development of any new drug for therapeutic evaluation. The information obtained from this review will assist in the development of the IND application and provides a clear roadmap forward for conducting the two planned clinical studies next year."
What now for Immuron?
The Immuron share price has seen a stark reversal in fortunes this year, jumping 275% on 9 June in response to news of the briefing documentation mentioned above being submitted to the FDA.
While this is good news, Immuron's drug is still in its very early days and will need a lot of stones to fall into place for it to hit the market. In saying this, the FDA guidance is a huge step forward, hence today's movement in the Immuron share price.
