New York-based Intrommune Therapeutics, a clinical-stage biotech firm is currently in Phase 1 clinical trials with INT301, a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste and conveniently administered during a patient’s daily toothbrushing routine.
Having recorded no significant adverse reactions to date through two Phase 1 cohorts where the doses administered were gradually increased over time, the company has amended their Phase 1 study to determine the maximum tolerated dose (MTD).
Said Michael Nelson, CEO, Intrommune Therapeutics:
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. 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.
Said Dr William Berger, Medical Director of Allergy & Asthma Network:
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.