Inflammatory Response Research Announces Positive Data from Phase 1 Pilot Study of IRR-401 in COVID Patients

Data from the study of IRR-401, a proprietary combination of levocetirizine and montelukast, suggests the combination therapy may prevent disease progression from mild to moderate to severe

SANTA BARBARA, Calif.–(BUSINESS WIRE)–#COVID–Inflammatory Response Research, Inc. (“IRR”), a drug development company focused on pharmaceutical products for the treatment of inflammatory disorders and conditions, today announced positive data from a Phase 1 Pilot Study of IRR-401 in COVID-19 (+) patients. Clinical data suggests the combination therapy may prevent the progression from mild to moderate to severe, as well as prevent/treat many of the aspects of ‘Long COVID,’ thereby cost effectively reducing both morbidity and mortality.

“We are very pleased with the results of this pilot study in COVID positive patients,” stated Dr. B. Chandler May, Chief Executive Officer of IRR. “The latest variant is considered highly contagious. Primary objectives are to decrease the requirement for hospitalization and reduce complications associated with the disease. Importantly, IRR-401 can address the cardinal symptom in moderate disease, shortness of breath. This data demonstrates the potential to reduce severity, including those patients with underlying medical conditions.”

IRR-401 is a proprietary combination of levocetirizine and montelukast. Levocetirizine, a third-generation antihistamine, and montelukast, a leukotriene receptor antagonist, exhibit remarkable synergistic anti-inflammatory activity across a spectrum of signaling proteins, cell adhesion molecules, and leukocytes. By targeting cellular protein activity, they have the potential to treat the symptoms of COVID-19. Both compounds are separately approved by the U.S. Food and Drug Administration for other indications and collectively have millions of days of patient use.

Data is available in the February 2022 edition of International Immunopharmacology: https://www.sciencedirect.com/science/article/pii/S1567576921010481

In the peer reviewed article, 53 consecutive COVID-19 test (+) cases (ages 3–90) from a well-established, single-center practice in Boston, Massachusetts, between March and November 2020, were treated with levocetirizine and montelukast in addition to then existing protocols. The data set was retrospectively reviewed. Thirty-four cases were considered mild (64%), 17 moderate (32%), and 2 (4%) severe. Several patients presented with significant comorbidities (obesity: n = 22, 41%; diabetes: n = 10, 19%; hypertension: n = 24, 45%). Among the cohort there were no exclusions, no intubations, and no deaths. The pilot study in Massachusetts encompassed the first COVID-19 wave which peaked on April 23, 2020 as well as the ascending portion of the second wave in the fall. During this period the average weekly COVID-19 case mortality rate (confirmed deaths/confirmed cases) varied considerably between 1 and 7.5%.

Dr. Holly Gallivan, who independently treated the patients, stated, “The combination has the promising potential to prevent severe and long-haul illness due to COVID-19. In this Phase I study, the therapy was well tolerated.”

The next step in the development of IRR-401 is a multicenter, randomized, placebo-controlled, Phase 2 clinical trial, replete with electronic diaries and laboratory metrics to explore scientific questions not addressed in the Phase 1 study.

About Inflammatory Response Research, Inc.

Inflammatory Response Research, Inc. (IRR) is a drug development company focused on pharmaceutical products for the treatment of inflammatory disorders and conditions. Given the COVID-19 pandemic, the current focus is on a safe and effective therapeutic for use in the global treatment paradigm. In parallel development is a ‘First Response’ injectable to treat acute inflammation associated with polytrauma (all trauma) as well as traumatic brain injury. The first product under development is IRR-401, a proprietary combination of levocetirizine and montelukast. For more information, please visit www.irrinc.net.

Contacts

Investor Contact:

B. Chandler May, MD, JD, MS, FCLM

Santa Barbara, CA

805-681-1522

[email protected]