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Intrommune Therapeutics Completes Enrollment in the Phase 1 OMEGA Study for Peanut Allergy
Observed only mild and transient adverse events, with no use of emergency epinephrine
Observed 98.4% patient compliance to date with novel OMIT therapeutic modality
Safely started patients on dose 4, potentially reducing the time to reach maintenance by several weeks
NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology company developing a patient-friendly treatment platform for peanut and other food allergies, today announced completion of enrollment in the Phase 1 OMEGA Clinical Study for patients with peanut allergy. The Phase 1 OMEGA Clinical Trial is a 48-week trial, including up to 34 weeks of maintenance therapy, in peanut allergic adults. The results of this trial, including the initial results of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC), will provide long-term safety data and inform the starting dose while further defining the clinical profile of INT301. INT301 is a novel peanut desensitization immunotherapy formulated in a fully-functioning toothpaste conveniently administered during a patient’s daily toothbrushing routine.
“Fully enrolling the OMEGA Clinical Study is a significant milestone for Intrommune as we continue to progress our innovative platform of products to help patients with food allergies, including peanut allergy,” said Michael Nelson, CEO, Intrommune Therapeutics. “We are encouraged that, to date, patients enrolled in our OMEGA Clinical Study have only experienced mild, transient adverse events with no use of emergency epinephrine. Additionally, we have both been able to safely start patients at dose 4 which may shorten the time to reach maintenance therapy by several weeks, and successfully dosed patients to a dosage higher than our expected maintenance dose.”
Intrommune Therapeutic’s Phase 1 OMEGA Clinical Study is a randomized, double-blind, placebo-controlled, study that enrolls adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The study groups are blinded to the investigator, patients, and the Intrommune study team. Earlier this year the FDA allowed amendments to the OMEGA Clinical Study protocol to determine the maximally tolerated dose and to allow the addition of a maintenance period which will include a DBPCOFC at the end of the trial.
Food allergies affect more than 220 million people worldwide, including approximately 32 million people in the U.S. Management of food allergies currently focuses on avoidance of exposure to triggering foods, though often such foods, including peanuts, are common ingredients in food products and therefore difficult to avoid. Many people with peanut allergy are accidentally exposed and experience potentially life-threatening reactions, including anaphylaxis, each year. Unfortunately, food allergy remains an area of tremendous unmet medical need.
Oral mucosal immunotherapy (OMIT) uses a specially formulated toothpaste to stabilize and deliver allergenic proteins to immunologically active areas of the oral cavity with the greatest potential for allergy desensitization. Success with allergy immunotherapy hinges on consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration, which supports the potential for improved adherence.
Intrommune, dedicated to improving and protecting the lives of people with food allergy, is developing the revolutionary oral mucosal immunotherapy (OMIT) treatment platform for food allergies. OMIT is a patient-friendly solution for over 220 million people worldwide, including 32 million people in the U.S., who suffer from life-altering food allergies. Intrommune Therapeutic’s lead product, INT301, has entered Phase 1 clinical trials. All of Phase 1 results along with future studies are intended to support OMIT as being a safe, effective and convenient therapy for patients who suffer from peanut allergy.