US DoD Naval Medical Research Center Receives FDA Guidance on the clinical development plans for new oral therapeutic
Immuron Limited (ASX: IMC; NASDAQ: IMRN) has received FDA guidance on a new oral therapeutic targeting Campylobacter and ETEC infections. Two Phase II clinical trials are set for 2021; one will assess protection against campylobacteriosis, while the other will focus on ETEC. The FDA meeting discussed manufacturing controls and planned studies to evaluate the therapeutic's safety and efficacy. The company is also progressing on its manufacturing program, with the second immunization campaign completed and colostrum harvesting scheduled for September, crucial for drug production.
- FDA guidance received for the development of new oral therapeutic targeting Campylobacter and ETEC.
- Two Phase II clinical trials scheduled for 2021, focusing on campylobacteriosis and ETEC infections.
- Manufacturing program is on track, with colostrum harvest planned for September.
- None.
Key Points
- NMRC received guidance from the FDA on the development of a new oral therapeutic targeting Campylobacter and ETEC
- Two human phase II clinical trials to be conducted in 2021
- One trial will focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis
- The second trial will focus on ETEC infections
MELBOURNE, Australia, July 20, 2020 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that the Naval Medical Research Center (NMRC) has received written guidance from the U.S. Food and Drug administration (FDA) in relation to the clinical development pathway of a new investigational drug which the company is developing to treat moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections.
The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy of the product which the company is developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea.
The FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1. Following FDA review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as providing additional guidance and comments to support the planned IND submission.
“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,” said Dr. Jerry Kanellos, CEO of Immuron Ltd. “The company is also please to inform shareholders that the manufacturing program is proceeding as planned. We have completed the second immunisation campaign and are on schedule to harvest the Hyper-immune colostrum in September this year which will be used to manufacture the drug product that will be used to treat moderate to severe campylobacteriosis and ETEC infections.”
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Dr Jerry Kanellos, Ph.D.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
For more information visit: http://www.immuron.com
FAQ
What is the focus of Immuron's new oral therapeutic?
When are the Phase II clinical trials for Immuron's therapeutic scheduled?
What are the planned outcomes of the clinical trials?
What guidance did Immuron receive from the FDA?
What is the significance of the FDA meeting for Immuron?
