US DoD Naval Medical Research Center Requests Meeting with FDA for Guidance on two Phase 2 trials to Prevent Acute Infectious...
June 09 2020 - 6:00AM
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 provide shareholders with
an update on the company’s research collaboration with the Naval
Medical Research Center (NMRC) to develop and clinically evaluate a
new therapeutic against campylobacter and ETEC (E-Coli). The NMRC
recently requested a Pre-IND meeting with the U.S. Food and Drug
administration (FDA) regarding its new investigational drug which
the company is developing to treat moderate to severe
campylobacteriosis and ETEC infections.
The FDA on the 26 May 2020 issued guidance
explaining how the coronavirus disease public health emergency is
impacting the conduct of formal meetings and its review of certain
user fee-funded applications. The FDA will focus its resources on
applications and submissions related to COVID-19 and other
life-threatening conditions. The FDA will still aim to conduct
initial investigational new drug application (IND) 30-day safety
reviews and respond to “other important safety issues that may
emerge during IND development”. The agency will provide written
comments on the non-clinical information in the Pre-IND information
package which is planned to be submitted on the 10th of June 2020.
Following the FDA’s guidance and feedback, the NMRC plans to file
an investigational new drug (IND) application later this year and
commence the Phase 2 clinical studies during the first half of
2021.
“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, CEO of Immuron Ltd.
“The Australian Importation permit required to
ship the vaccines from the NMRC was approved by Biosecurity
Australia and the NMRC vaccines were shipped to our contract
research partner to commence the project. The COVID-19 pandemic put
the brakes on this and all our research and development activities.
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.”
The COVID-19 pandemic has also impacted the
IMM-124E pediatric clinical study in Nonalcoholic Fatty Liver
Disease. The study’s Principle Investigator Dr. Miriam Vos from the
Emory University School of Medicine closed the study earlier this
year with only 22 subjects out of a target 40 completing treatment
as specified in the study protocol. The study findings were
reported as negative which was not unexpected given the small
sample set used in the analysis and there was no substantial
changes in ALT (Primary study end point) in the active arm of the
study when compared to placebo.
COMPANY CONTACT: Dr
Jerry Kanellos, Ph.D.Chief Executive OfficerPh: +61 (0)3
9824 5254info@immuron.com
For more information visit:
http://www.immuron.com
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