Study met all primary and secondary safety endpoints, demonstrating INT301 was well-tolerated
A small subset analysis provided indications of efficacy
Full data set to be reported next year, followed by initiation of the Phase 2 clinical trial in a pediatric population
NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, will present top-line results of the Phase 1 OMEGA (Oral Mucosal Escalation Goal Assessment) clinical trial during a late-breaking oral presentation at this year’s American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Anaheim, California. The data demonstrates that INT301, an innovative specially formulated toothpaste, can safely be used to deliver Oral Mucosal Immunotherapy (OMIT). The presentation is scheduled for Saturday, November 11 from 9:50 - 10:00 A.M. PST.
The Phase 1 OMEGA Clinical Trial was a 48-week, double-blind, placebo-controlled trial involving 32 adult patients with peanut allergy to assess the safety of INT301. INT301 represents a new approach to peanut desensitization in a fully functioning toothpaste that can easily be incorporated into a patient’s daily toothbrushing routine. The study showed that 100% of those treated with the toothpaste consistently tolerated the pre-specified protocol highest dose. No moderate nor severe systemic reactions occurred in participants undergoing treatment. Non-systemic adverse reactions were mostly local, such as oral itching, mild, and transient. Adherence to treatment reached 97% with no dropouts due to the study medication.
“There are very few options available to patients with peanut allergy other than avoidance,” said William E. Berger, MD, a board-certified allergist and consultant to Intrommune. “The only other approved product available at the present time requires extensive time and preparation to administer and is, unfortunately, associated with systemic side effects, including stomach pain and anaphylaxis. OMIT appeared to be a safe and convenient option for adults with food allergies. I look forward to the continued development of this therapeutic toothpaste in a pediatric population.”
A subset analysis evaluated a small group of participants who underwent a Double-Blind, Placebo Controlled, Oral Food Challenge (DBPCOFC) at both study entry and study exit. All of the participants receiving active treatment were able to successfully ingest at least 300 mg of peanut protein (equivalent to 1 – 1.5 peanuts) during the exit DBPCOFC, while this was only achieved in 50% of the patients on placebo. These results support further investigation of INT301 for the treatment of peanut allergy.
“Reporting the results of the OMEGA trial is an important milestone for Intrommune as we continue to advance our innovative products to treat patients with food allergies, starting with peanut allergy,” said Michael Nelson, CEO, Intrommune Therapeutics. “We expect the full data set of this trial to be reported next year and are focused on carefully designing a Phase 2 trial to investigate the efficacy of INT301 in a pediatric study.”
About the OMEGA Trial
Intrommune Therapeutic’s Phase 1 OMEGA Clinical Study was a randomized, double-blind, placebo-controlled study that enrolled 32 adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The study groups were blinded to the investigator, patients, and sponsor. During the course of the trial, the United States Food and Drug Administration allowed amendments to the OMEGA Clinical Study protocol to determine the maximally tolerated dose and to allow the addition of a maintenance period which included a DBPCOFC at the end of the trial.
About Peanut and Other Food Allergies
Food allergies affect more than 220 million people worldwide, including approximately 32 million people in the United States. 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) utilizes complex patented biochemical processes to stabilize and deliver allergenic proteins in a fully functional toothpaste. By simply brushing your teeth, the allergenic proteins are delivered 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 United States, who suffer from life-altering food allergies. Intrommune Therapeutic’s lead product, INT301, has completed its Phase 1 clinical trial. All 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 www.intrommune.com
Contact:
Stuart Loesch
Intrommune Therapeutics
(484) 942-0323
sloesch@intrommune.com
Jen Zoller
Green Room Communications
(973) 975-5421
jzoller@grcomms.com
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