Immune Therapeutics Seeking FDA Approval for Phase 3 Clinical Trial of Lodonal, A Treatment for Crohn\’s Disease

The Company’s drug discovery and development are focused in two areas – one is the role of Toll-Like Receptors (TLRs) and Inflammation signaling in human immunology as well as the opioid receptors which has been shown to participate in the function of the cells of the immune system, and evidence suggests that opioids modulate both innate and acquired immune responses.

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Immune Therapeutics Seeking FDA Approval for Phase 3 Clinical Trial of Lodonal, A Treatment for Crohn’s Disease

IMMUNE THERAPEUTICS, INC. Logo

IMMUNE THERAPEUTICS, INC. 
Ticker: IMUN 
https://www.Immunetherapeutics.com

IMUN – A LATE STAGE BIOPHARMACEUTICAL COMPANY

Immune Therapeutics, Inc. focuses on the development of two immunomodulating therapies (IRT-103 “Lodonal™” and IRT-101″MENK”) for the treatment of autoimmune diseases, inflammatory diseases, cancer and HIV/AIDs. 

The Company’s drug discovery and development are focused in two areas – one is the role of Toll-Like Receptors (TLRs) and Inflammation signaling in human immunology as well as the opioid receptors which has been shown to participate in the function of the cells of the immune system, and evidence suggests that opioids modulate both innate and acquired immune responses.

WHAT MAKES IMMUNE THERAPEUTICS, INC UNIQUE?

While traditional drug development targets a single drug for a particular disease such as drug A for disease A, drug B for disease B, etc., IMUN and Cytocom are approaching the process by identifying and targeting survival or activation immunology pathways that cross over between different diseases.IMUN’s lead product Lodonal shows the success of this model with approval in Nigeria and the Dominican Republic for HIV/AIDS, Cancer and other autoimmune disease.

THE LATEST UPDATE FROM IMUN:

Immune Therapeutics on behalf of Cytocom, the license holder, and the US Food and Drug Administration (FDA) are discussing next steps in the development of IRT-103 a oral once-a-day an adjunct therapy to the standard of care for moderate to severe Crohn’s disease in adults and mild to severe in pediatric patients. Immune Therapeutics plans to file an application with the FDA seeking sign-off on a Phase 3 clinical trial assessing IRT-103, branded as Lodonal, for the treatment of patients at least 12 years old with moderate-to-severe Crohn’s disease. 

IMUN CEO Noreen Griffin comments, “We are thrilled to be taking next steps in the development of Lodonal™ with the FDA. Based upon the discussion with the FDA and the minutes received following the meeting, IMUN / Cytocom intends to immediately move forward with its IND 067442 submission for the Phase 3 pivotal clinical program for moderate to severe Crohn’s disease in patients 12 and over.”

The company also plans to seek FDA sign-off on an IND for Lodonal in pediatric patients ages 2 – 11 with mild-to-severe Crohn’s.

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