Intrommune Therapeutics, the New York-based, clinical-stage biotech company developing a patient-friendly treatment platform for peanut and other food allergies, today announced an initial update from its ongoing Phase 1 Trial of INT301 (dubbed “OMEGA”) in patients with peanut allergy.
INT301 is a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste and conveniently administered during a patient’s daily toothbrushing routine.
The OMEGA trial is a randomized, double-blind, placebo-controlled study that enrolled adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or a placebo. Cohort 1 patients started at the lowest dose and were titrated through four increasing doses of INT301. The study groups are blinded to the investigator, participants, and the Intrommune study team.
Said Michael Nelson, CEO of Intrommune:
After acceptance of our [investigational new drug application by the FDA] for INT301, we launched and completed Cohort 1 of our Phase 1 OMEGA Clinical Study last year in adults with peanut allergy. While the study remains blinded, there were no significant adverse events in any patient. We believe that these results support the potential for oral mucosal immunotherapy (OMIT) to be a safe and convenient option for people with food allergies.
Based on pre-specified criteria including the safety profile of patients enrolled in Cohort 1, Intrommune’s internal safety committee approved the start of Cohort 2. Cohort 2 is designed to ascertain the next highest safe starting dose, which may shorten the period required to reach INT301 maintenance dosing. (Cohort 2 has been fully enrolled at this time.)
Said Dr Michael Blaiss, Clinical Professor of Pediatrics, Medical College of Georgia at Augusta University:
Today there is a high unmet need for other medical options in patients suffering from peanut allergy. The successful progress of this study of INT301 through its first safety hurdle is a very promising signal.
The company launched its Series B funding raise based on the positive feedback.