INT301 Continues to Meet Safety Goals in Phase 1 OMEGA Study in Adults with Peanut Allergy While Reaching Phase 2 Target Maintenance Dose
NEW YORK, April 06, 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 that its ongoing Phase 1 OMEGA Clinical Study of INT301 in adult patients with peanut allergy has been amended to allow determination of the Maximum Tolerated Dose (MTD). As previously disclosed, Cohort 1 completed up-titrating to Dose 4 with no significant adverse events. Patients with peanut allergy in Cohort 2 were started at Dose 2 and are being up-titrated through 11 increasing doses of INT301 to determine both a MTD and a safe starting dose. Patients in Cohort 3 are starting at Dose 3 and participants in Cohort 4 are expected to start at Dose 4. Cohort 2 has successfully up-titrated participants through 11 doses. Cohort 3 is currently enrolling. To date, there have been no significant adverse events. INT301 is a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste and conveniently administered during a patient’s daily toothbrushing routine.
“We are encouraged by the continued progress of our ongoing Phase 1 OMEGA Clinical Study in adults with peanut allergy. While the study remains blinded, we previously announced the completion of Cohort 1 and full enrollment of Cohort 2 with no significant adverse events in any adult patients with peanut allergy. We are now excited to report some patients receiving INT301 have reached Dose 11 in the ongoing OMEGA trial and no severe adverse events have been reported,” said Michael Nelson, CEO, Intrommune Therapeutics. “The continued encouraging results further support the potential for oral mucosal immunotherapy (OMIT) to be a safe and convenient option for people with food allergies.”
Intrommune Therapeutic’s Phase 1 OMEGA Clinical Study 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 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, patients, and the Intrommune study team.
Based on pre-specified criteria, including the safety profile of patients enrolled in Cohort 1 and Cohort 2, the internal Safety Monitoring Committee approved the opening of Cohort 3, starting patients at Dose 3, and potentially reducing the up-titration phase of INT301 by four weeks and two office visits. Phase 1 is designed to help ascertain the highest safe starting dose, which may shorten the up-titration period required to reach INT301 maintenance dosing.
“Patients suffering from peanut allergy are often concerned about the possibility of a severe allergic reaction caused by exposure to these foods. There continues to be a high unmet need for treatment options to help patients live their lives with less fear, and the progression of this study of INT301 is extremely encouraging,” said William Berger, M.D., M.B.A., Medical Director of Allergy & Asthma Network.