Observed only mild and transient side effects, with no emergency use of epinephrine
Observed 98.4% adherence to date with new OMIT therapeutic modality
Safely started patients on dose 4, potentially reducing time to maintenance by several weeks
NEW YORK, Oct. 26, 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 the completion of enrollment in the phase 1 OMEGA clinical trial for patients with peanut allergy. The phase 1 OMEGA clinical trial is a 48-week study, including up to 34 weeks of maintenance therapy, in adults with peanut allergies. The results of this study, including initial results from a double-blind placebo-controlled oral food challenge (DBPCOFC), will provide long-term safety data and inform starting dose while further defining the clinical profile of INT301. INT301 is a novel peanut desensitization immunotherapy formulated in a fully functioning toothpaste that is easily administered during a patient’s daily brushing routine.
“Full enrollment in the OMEGA clinical trial is an important milestone for Intrommune as we continue to develop our innovative platform of products to help patients with food allergies, including peanut allergy,” said Michael Nelson, CEO of Intrommune Therapeutics. “We are encouraged that patients enrolled in our OMEGA clinical trial have experienced only mild, transient side effects to date without emergency use of epinephrine. In addition, we have been able to safely start patients on dose 4, which can shorten the time to reach maintenance therapy by several weeks, as well as successfully dose patients to a dose higher than our expected maintenance dose.”
The Phase 1 OMEGA clinical trial of Intrommune Therapeutic is a randomized, double-blind, placebo-controlled trial enrolling adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The study groups are blinded to the investigator, patients, and the Intrommune research team. Earlier this year, the FDA allowed changes to the OMEGA Clinical Study protocol to determine the maximum tolerated dose and to allow for the addition of a maintenance period, including a DBPCOFC at the end of the study.
About peanuts and other food allergies
Food allergies affect more than 220 million people worldwide, including about 32 million people in the US. Food allergy management is currently focused on avoiding exposure to triggering foods, although such foods, including peanuts, are often common ingredients in food products and are therefore difficult to treat. to prevent. Many people with peanut allergies are accidentally exposed and experience potentially life-threatening reactions, including anaphylaxis, each year. Unfortunately, food allergy remains an area of huge 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 depends on consistent exposure of a patient’s immune system to gradually “desensitize” the patient over time to the specific allergy trigger. OMIT offers advantages over other allergy immunotherapy approaches due to its targeted delivery and simplified delivery, supporting the potential for improved adherence.
About Intrommune Therapeutics
Intrommune, committed to improving and protecting the lives of people with food allergies, is developing the revolutionary Oral Mucosal Immunotherapy (OMIT) treatment platform for food allergies. OMIT is a patient-friendly solution for more than 220 million people worldwide, including 32 million in the US, who suffer from life-changing food allergies. Intrommune Therapeutic’s lead product, INT301, has entered Phase 1 clinical trials. All phase 1 results, along with future studies, are intended to support OMIT as a safe, effective, and convenient therapy for patients suffering from peanut allergy.
For more information about Intrommune Therapeutics, please visit http://www.intrommune.com
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