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.