Intrommune Therapeutics 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).
INT301 Met Safety Goals Across Eleven Dose Levels
Patient Treatment Now Ongoing in Cohort 3
Intrommune Expands Study Scope to Explore MTD
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.
About Peanut and Other Food Allergies
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.
About Oral Mucosal Immunotherapy™
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.
About Intrommune Therapeutics
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.
For more information on Intrommune Therapeutics, please visit http://www.intrommune.com
Contact:
Stuart Loesch
Intrommune Therapeutics
(267) 740-2905
sloesch@intrommune.com
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