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FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES - OCTOBER, 2020 JERRY KANELLOS, Ph.D. CEO NASDAQ: IMRN ASX: IMC 1
DEVE L OPMENT PIPELINE 2
TRAVELAN COMMERCIAL PROFILE: A UD $ - 3 $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000 $3,000,000 FY17A FY18A FY19A FY20A $1.38M $2.01M $2.6M $2.7M Global Immuron Sales (Gross) - AUD
Plan to register Travelan as a drug in the USA with the FDA to reduce the risk of Travelers' Diarrhea (TD) in travelers to endemic areas: IMM - 124E DRUG DEVELOPMENT PLAN Execute Prevention Trial and File Registration Package 4 File IND with Plan for Double - Blind, Placebo Controlled Trial for Prevention of Travelers' Diarrhea Hold Pre - IND Meeting to Discuss Merits of Application to Prevent TD Assimilate Data to Support IND Submission to FDA to Prevent TD x x
US SALES FORECAST FOR TRAVELAN : IF APPROVED AS DRUG Market potential figure derived from: 2014 figures of US citizens traveling to high risk destinations for TD (44.3 million) 1 and obtaining pretravel advice (22.2 million) 2 . Sources of pre - travel advice include primary care provider, travel medicine specialist, company doctors, pharmacist, and travel agencies 2 . Our forecast utilizes a very conservative estimate for % of US citizens purchasing Travelan after seeking pre - travel advice. 1. U.S. Department of Commerce, International Trade Administration, National Travel and Tourism Office. U.S. Citizen Traffic to Overseas Regions, Canada & Mexico 2014. Monthly Statistics, U.S.Outbound Travel by World Regions. 2014. Available at: http://travel.trade.gov/view/m - 2014 - O - 001/index.html. Accessed June 26, 2015. 2. Mathyas Wang , MD , Thomas D. Szucs , MD, MBA, MPH, LLM , and Robert Steffen , MD. Economic Aspects of Travelers ' Diarrhea. Journal of Travel Medicine, Volume 15, Issue 2, 2008, 110 - 118 MARKET POTENTIAL FOR TRAVELAN SALES: USD >$100 MILLION 5
A RANDOMIZED, DOUBLE - BLIND, PLACEBO - CONTROLLED TRIAL EVALUATING THE EFFICACY OF NON - ANTIBIOTIC OTC PRODUCTS IN TRAVELERS' DIARRHEA (TD) PREVENTION (P4TD) 6 CURRENT STATUS - PLAN TO C 0 MMENCE ENROLMENT JUNE 2021 Primary Objective : To evaluate the clinical efficacy of Travelan , Florastor and Bimuno vs . placebo for maintenance of Gastrointestinal Health (GH) focusing on a 10 day window of prophylaxis during travel . STUDY DESIGN This is a randomized ( 1 : 1 : 1 : 1 allocation), double - blind, placebo controlled multicenter clinical trial comparing three dietary supplements, Travelan , Florastor and Bimuno , individually against placebo to determine efficacy for maintenance of GH . A total of 1320 subjects ( 330 /arm) will be enrolled from the following populations : active duty US and UK military personnel, US DoD beneficiaries and US civilians deploying or traveling to intermediate or high GH disruption risk destinations .
Two Human Clinical Trials Planned: New Drug to Reduce the risk of Infectious Diarrhea Caused by Campylobacter and by ETEC US NAVEL MEDICAL RESEARCH CENTRE DRUG DEVELOPMENT PLAN Execute Prevention Trials 7 File IND with Plans for two Double - Blind, Placebo Controlled Prevention Trials Hold Pre - IND Meeting to Discuss Merits of Application to Prevent TD Assimilate Data to Support IND Submission to FDA to Prevent TD x x
Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridiodes difficile Infection: IMM - 529 DRUG DEVELOPMENT PLAN Execute recurrence prevention trial 8 File IND with plan for placebo controlled trial for prevention of disease recurrence Hold pre - IND meeting to discuss clinical protocol and strategy Develop clinical registration strategy for FDA submission
Immuron Reports Neutralizing activity Against SARS - CoV - 2 9 Key Points Immuron's Hyper - immune Bovine Colostrum used to manufacture Travelan and Protectyn demonstrates antiviral activity against the COVID - 19 virus in laboratory studies Immuron's technology platform offers a potential new oral therapeutic approach to target SARS - CoV - 2 in the GI Tract Melbourne, Australia, July 21, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that the hype - Immune bovine colostrum used to manufacture the company's flag ship commercially available and over - the - counter gastrointestinal and digestive health immune supplements Travelan and Protectyn has demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus - 2 (SARS - CoV - 2), the virus that causes COVID - 19.
IMM - 124E SARS - COV - 2 RESEARCH & DEVELOPMENT PROPOSAL 10 CURRENT STATUS RESEARCH & DEVELOPMENT Reached out to local, national, and international potential research collaborators to advance this work and assist in the further characterization of the neutralization activity of SARS - CoV - 2 observed with IMM - 124E Research Services Agreements To identify the inhibitory substance/s in IMM - 124E Preclinical Development Access application form for a contract research project - submitted The project aims to assess the effect of IMM - 124E in ex - vivo and animal models infected with SARS - CoV - 2
IMM - 124E SARS - COV - 2 RESEARCH & DEVELOPMENT PROPOSAL 11 CURRENT STATUS CLINICAL PROPOSALS Consultancy agreement executed with Professor Teena Chopra, Professor of Medicine Wayne State University School of Medicine, Detroit Professor Chopra is building a registry of the patients presenting with gastrointestinal events to better understand this cohort and the unique medical challenges they present Clinical protocol development Reviewing several proposals to assess the efficacy of IMM - 124E to treat patients with COVID - 19