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 an amendment to its ongoing Phase 1 OMEGA Clinical Study of INT301 in adult patients with peanut allergy.
The amendment increases the study duration for patients to 48 weeks to include a maintenance period. This maintenance period allows for the evaluation of safety after long-term use of INT301. Additionally, the amendment allows for the inclusion of a Double-Blind Placebo-Controlled Oral Food Challenge (DBPCOFC) at the end of treatment.
The OMEGA Phase 1 Clinical Trial, including the initial results of the DBPCOFC, will inform the dosing regimen and design of future clinical studies. INT301 is a novel peanut desensitization immunotherapy formulated as a fully-functioning toothpaste conveniently administered during a patient’s daily toothbrushing routine.
“We continue to make steady progress in the clinical development of INT301 for peanut allergy. We are encouraged by the FDA clearance of this amendment to our ongoing Phase 1 OMEGA Clinical Study, which will now include an evaluation of the long-term safety of INT301 in peanut-allergic adults and inform the design of future studies,” said Michael Nelson, CEO, Intrommune Therapeutics.
He added, “We are encouraged that most patients remaining in Cohort 2 and Cohort 3 when we received this allowance from the FDA consented to maintenance dosing, even though this requires undergoing an additional oral food challenge. The support and interest we have received from patients and physicians has reassured us that we are developing a product that patients need and want.”
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. 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. Earlier this year the FDA allowed an amendment to the OMEGA Clinical Study to determine Maximally Tolerated Dose in Cohorts 2 through 4.
Cohort 3 is fully enrolled, and to date, no patient on Cohort 1 through 3 has had a significant or even moderate adverse event that is related to the study treatment. All study-related adverse events have been mild and transient. Based on pre-specified criteria, including the safety profile of patients enrolled in Cohorts 1 through 3, the internal Safety Monitoring Committee approved the opening of Cohort 4, starting patients at Dose 4. 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, reduce the number of office visits required and making the most convenient immunotherapy option even more convenient.
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.