FDA Accepts Investigational New Drug Application for Peanut Allergy Candidate Developed by COUR Pharmaceuticals

CHICAGO, Sept. 16, 2021 /PRNewswire/ -- COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles to treat immune disorders (CNPs), today announced the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for evaluation of COUR's CNP-201 in a proof-of-concept (Phase 1 / 2) study in people who are allergic to peanuts.

"This will be the first clinical trial with a first-in-class therapy to re-program the immune system to stop the allergic response to peanuts," said John J. Puisis, co-founder, president & CEO of COUR. "Our hope is the clinical trials will confirm that CNP-201 can help eliminate the potentially fatal health risks associated with patients who have a peanut allergy."

CNP-201 is a biodegradable nanoparticle encapsulating purified peanut protein extract and administered through intravenous infusion. The nanoparticles containing peanut allergens are consumed by immune presenting cells. When the particles and allergens are presented by the immune presenting cell, they trigger a reprogramming of the cellular functions of the immune system, reducing and possibly eliminating the potential risk of severe allergic reactions.

Peanut allergy is the most common food allergy in children under age 18 and the second-most common food allergy in adults. A recent study in the Journal of Allergy and Clinical Immunology found that as many as 4.6 million US adults are allergic to peanuts.

The immune systems of people with peanut allergy can mount an abnormal immune response to even tiny amounts of peanuts and trigger a serious reaction in minutes leading to life-threatening anaphylaxis. The proof-of-concept study will evaluate the safety and potential efficacy of CNP-201 in people ages 16 to 55 with peanut allergy.

"The nanoparticles reprogram upstream T cells to shut down B cell's responsible for  the production of allergic Immunoglobulin E (IgE) antibodies, which result in significant and deadly allergic responses," Mr. Puisis explained. "This is a revolutionary endeavor because today the only therapy is de-sensitization, that softens the blow of allergic IgE, but can never shut it down."

Kari Nadeau, M.D., Ph.D., Director, and Sharon Chinthrajah, MD, Clinical Research Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, added, "Our team were early supporters of the potential of COUR's immune reprogramming platform, so we're eager to see data showing CNP-201 can reprogram T cells, shut down B cells, and protect the allergy patient from continual B cell production of IgE and associated allergic cytokines, which are so deleterious to patients' quality-of-life."

CNP-201 is COUR's second nanoparticle immune-modifying drug to enter clinical trials. The first, CNP-101 for celiac disease, is partnered with Takeda Pharmaceuticals Company. COUR's breakthrough nanoparticle immune modifying platform, which preserves all immune functionality, is potentially applicable in treating any autoimmune or allergic condition.

About COUR Pharmaceuticals

COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR's platform of immune-modifying nanoparticles treats the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression. COUR's lead product for celiac disease, partnered with Takeda Pharmaceutical Company, is the first demonstration of induction of antigen-specific T cell immune reprogramming in any autoimmune disease. Data from clinical and preclinical settings demonstrate the opportunity for the COUR nanoparticle platform to address a wide range of immune and inflammatory conditions. The underlying technology was acquired from Northwestern University and draws from more than 30 years of research by the laboratory of Stephen D. Miller, Ph.D., the Judy E. Guggenheim Research Professor of Microbiology-Immunology.

Media Contact:

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SOURCE COUR Pharmaceuticals