Noticed solely gentle and transient antagonistic occasions, with no use of emergency epinephrine
Noticed 98.4% affected person compliance so far with novel OMIT therapeutic modality
Safely began sufferers on dose 4, probably lowering the time to succeed in upkeep by a number of weeks
NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) — Intrommune Therapeutics, Inc., a New York-based, scientific stage biotechnology firm creating a patient-friendly therapy platform for peanut and different meals allergy symptoms, at this time introduced completion of enrollment within the Section 1 OMEGA Scientific Examine for sufferers with peanut allergy. The Section 1 OMEGA Scientific Trial is a 48-week trial, together with as much as 34 weeks of upkeep remedy, in peanut allergic adults. The outcomes of this trial, together with the preliminary outcomes of a Double-Blind Placebo Managed Oral Meals Problem (DBPCOFC), will present long-term security knowledge and inform the beginning dose whereas additional defining the scientific profile of INT301. INT301 is a novel peanut desensitization immunotherapy formulated in a fully-functioning toothpaste conveniently administered throughout a affected person’s each day toothbrushing routine.
“Absolutely enrolling the OMEGA Scientific Examine is a major milestone for Intrommune as we proceed to progress our progressive platform of merchandise to assist sufferers with meals allergy symptoms, together with peanut allergy,” stated Michael Nelson, CEO, Intrommune Therapeutics. “We’re inspired that, so far, sufferers enrolled in our OMEGA Scientific Examine have solely skilled gentle, transient antagonistic occasions with no use of emergency epinephrine. Moreover, we’ve each been in a position to safely begin sufferers at dose 4 which can shorten the time to succeed in upkeep remedy by a number of weeks, and efficiently dosed sufferers to a dosage greater than our anticipated upkeep dose.”
Intrommune Therapeutic’s Section 1 OMEGA Scientific Examine is a randomized, double-blind, placebo-controlled, examine that enrolls adults with peanut allergy in a 3:1 ratio to obtain both an escalating dose of INT301 or placebo. The examine teams are blinded to the investigator, sufferers, and the Intrommune examine crew. Earlier this yr the FDA allowed amendments to the OMEGA Scientific Examine protocol to find out the maximally tolerated dose and to permit the addition of a upkeep interval which can embrace a DBPCOFC on the finish of the trial.
About Peanut and Different Meals Allergy symptoms
Meals allergy symptoms have an effect on greater than 220 million individuals worldwide, together with roughly 32 million individuals within the U.S. Administration of meals allergy symptoms presently focuses on avoidance of publicity to triggering meals, although typically such meals, together with peanuts, are widespread components in meals merchandise and due to this fact tough to keep away from. Many individuals with peanut allergy are by accident uncovered and expertise probably life-threatening reactions, together with anaphylaxis, annually. Sadly, meals allergy stays an space of large unmet medical want.
About Oral Mucosal Immunotherapy™
Oral mucosal immunotherapy (OMIT) makes use of a specifically formulated toothpaste to stabilize and ship allergenic proteins to immunologically energetic areas of the oral cavity with the best potential for allergy desensitization. Success with allergy immunotherapy hinges on constant publicity of a affected person’s immune system to steadily “desensitize” the affected person to the precise allergy set off over time. OMIT presents benefits over different approaches to allergy immunotherapy as a consequence of its focused supply and simplified administration, which helps the potential for improved adherence.
About Intrommune Therapeutics
Intrommune, devoted to bettering and defending the lives of individuals with meals allergy, is creating the revolutionary oral mucosal immunotherapy (OMIT) therapy platform for meals allergy symptoms. OMIT is a patient-friendly answer for over 220 million individuals worldwide, together with 32 million individuals within the U.S., that suffer from life-altering meals allergy symptoms. Intrommune Therapeutic’s lead product, INT301, has entered Section 1 scientific trials. All of Section 1 outcomes together with future research are meant to assist OMIT as being a secure, efficient and handy remedy for sufferers that suffer from peanut allergy.
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