IMMUNIMED INC. is an Innovative, clinical stage Biopharmaceutical company initially developing Oral Antibodies to cure C Difficile Infection. We now intend to deliver a preventive treatment against CDI, with annual revenue projections in excess of $5B.

Clostridioides Difficile Infection is also called C Difficile, C Diff or CDI.

• C Difficile Infection is now the most common hospital acquired illness in the U. S., with an annual cost of more than $5B to its Healthcare system. It is also classified as an “urgent threat” (the highest category) by the Center for Disease Control (CDC) for Antimicrobial Resistance (AMR).
• Approximately 50% of CDI cases are now found to originate outside of hospitals, raising concern for the uninformed public with limited knowledge of the disease.
• C Diff is a gram positive spore forming bacteria that causes profuse diarrhea, nausea, cramping, colitis and death in some cases. It infects 500,000 and kills 30,000 North Americans every year. It also has a high probability of reinfecting the same patient multiple times over many months.
• Almost all cases of C Diff infection occur while you’re taking antibiotics or not long thereafter. This happens because these antibiotics knock out your gut microflora making you susceptible to CDI.
• Clinical trials of our orally administered antibodies to treat CDI, have shown a 94% cure rate after 130 patients. The highest cure rate of all treatments and with no negative side effects.
• We now intend to expand this trial and use a combination of these antibodies as a preventive treatment against CDI.

1. Prevention of C Difficile Infection recurrence. Competitors in this space include Zinplava (monoclonal antibody) from Merck, with patent expiring in 2025, priced at $4,000 per infusion; Rebyota (pre packaged enema) from Ferring Pharmaceuticals, priced at $9,500 per treatment; Vowst (FMT capsules) from Seres Therapeutics, priced at $17,500 per 3 day treatment. For safety reasons, Rebyota and Vowst are only permitted for use after the antibiotic standard of care has failed three times. Our preventive treatment would not be subject to these restrictions. Furthermore, we expect our treatment results will be superior to Zinplava, while being price competitive.
2. Prevention of Hospital acquired CDI (now the most common hospital acquired infection in the United States) will be the simple daily administration of our very safe and nutritionally beneficial oral antibodies to all hospital patients.
3. Prevention of CDI in the general community, where 50% of cases are now occurring. As CDI is associated with the use of broad spectrum antibiotics, which typically come with a label warning of this association, the daily use of our preventive antibodies over a short period of time, while taking the antibiotic treatment, will reduce and possibly eliminate this problem. The market here is everyone taking a broad spectrum antibiotic and concerned about CDI.

Cost of Clinical Trials
Typical vaccine clinical trials are very expensive as they require many subjects on the treatment and placebo arms to develop useable statistical evidence of preventing the disease. They also take many years to determine long term safety of the treatment. For C Difficile infection and our treatment in particular, these numbers can be significantly reduced.
First, almost all C Diff cases involve patients who are taking or have taken a broad spectrum antibiotic; second, most cases develop in hospitals. These two factors can shrink the number of subjects in the trial. And as our treatment is considered GRAS (Generally Regarded As Safe), long term safety is not an issue.