FDA Accepts Investigation Request for New Drug for Peanut Allergic Candidate Developed by COUR Pharmaceuticals
CHICAGO, September 16, 2021 / PRNewswire / – COUR Pharmaceuticals, a biotechnology company developing novel immuno-modifying nanoparticles to treat immune disorders (CNP), today announced that the United States Food and Drug Administration (FDA) has accepted the application Company’s New Investigational Drug (IND) for the evaluation of COURT’s CNP-201 in a proof of concept (Phase 1/2) study in people with peanut allergies.
“This will be the first clinical trial with a first-class therapy to reprogram the immune system to stop the allergic response to peanuts,” said Jean J. Puisis, co-founder, president and CEO of COUR. “We hope that clinical trials will confirm that CNP-201 can help eliminate the potentially fatal health risks associated with patients with peanut allergy.”
CNP-201 is a biodegradable nanoparticle encapsulating a peanut protein extract purified and administered by intravenous infusion. Nanoparticles containing peanut allergens are consumed by immune presenting cells. When particles and allergens are presented by the immune presenting cell, they trigger reprogramming of 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 18 and the second most common food allergy in adults. A recent study in the Journal of Allergy and Clinical Immunology have found that up to 4.6 million American adults are allergic to peanuts.
The immune system of people with peanut allergies can trigger an abnormal immune response to even small amounts of peanuts and trigger a severe reaction within minutes, leading to life-threatening anaphylaxis. The proof of concept study will assess the safety and potential efficacy of CNP-201 in people aged 16 to 55 years with peanut allergies.
“Nanoparticles reprogram T cells upstream to shut down B cells responsible for producing allergic immunoglobulin E (IgE) antibodies, which cause significant and fatal allergic responses,” said Puisis. “This is a revolutionary undertaking because today the only therapy is desensitization, which alleviates the shock of allergic IgE, but can never stop it.”
Kari nadeau, MD, 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 early supported the potential of COUR’s immune reprogramming platform. We are therefore eager to see data showing that CNP-201 can reprogram T cells, shut down B cells and protect the allergic patient from the continued production of IgE B cells and associated allergic cytokines, so deleterious to the quality. of patients’ lives. “
CNP-201 is COURT’s second nanoparticle-based immuno-modifying drug to enter clinical trials. The first, CNP-101 for celiac disease, is in partnership with Takeda Pharmaceuticals Company. COUR’s revolutionary nanoparticle immune modification platform, which preserves all immune functionality, is potentially applicable in the treatment of any autoimmune or allergic disease.
About COUR Pharmaceuticals
COUR Pharmaceuticals develops world-leading therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated diseases. COUR’s immunity-modifying nanoparticle platform treats the root cause of immune diseases, unlike traditional approaches, which only minimize symptoms by using toxic immune suppression. COUR’s flagship celiac disease product, in partnership 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 treat a wide range of immune and inflammatory conditions. The underlying technology was acquired from Northwestern University and is based on more than 30 years of research from the laboratory of Stephen D. Miller, Ph.D., Judy E. Guggenheim Research Professor in Microbiology-Immunology.
SOURCE COUR Pharmaceutical