Observed solely gentle and transient antagonistic occasions, with no use of emergency epinephrine
Observed 98.4% affected person compliance thus far with novel OMIT therapeutic modality
Safely began sufferers on dose 4, doubtlessly 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, medical stage biotechnology firm growing a patient-friendly remedy platform for peanut and different meals allergy symptoms, right now introduced completion of enrollment in the Phase 1 OMEGA Clinical Study for sufferers with peanut allergy. The Phase 1 OMEGA Clinical 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 Controlled Oral Food Challenge (DBPCOFC), will present long-term security information and inform the beginning dose whereas additional defining the medical profile of INT301. INT301 is a novel peanut desensitization immunotherapy formulated in a fully-functioning toothpaste conveniently administered throughout a affected person’s day by day toothbrushing routine.
“Fully enrolling the OMEGA Clinical Study is a significant milestone for Intrommune as we continue to progress our innovative platform of products to help patients with food allergies, including peanut allergy,” stated Michael Nelson, CEO, Intrommune Therapeutics. (*1*)
Intrommune Therapeutic’s Phase 1 OMEGA Clinical Study 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 workforce. Earlier this yr the FDA allowed amendments to the OMEGA Clinical Study protocol to find out the maximally tolerated dose and to permit the addition of a upkeep interval which is able to embody a DBPCOFC at the finish of the trial.
About Peanut and Other Food Allergies
Food allergy symptoms have an effect on greater than 220 million folks worldwide, together with roughly 32 million folks in the U.S. Management of meals allergy symptoms at present focuses on avoidance of publicity to triggering meals, although usually such meals, together with peanuts, are widespread elements in meals merchandise and subsequently troublesome to keep away from. Many folks with peanut allergy are by chance uncovered and expertise doubtlessly life-threatening reactions, together with anaphylaxis, every year. Unfortunately, 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 lively 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 progressively “desensitize” the affected person to the particular allergy set off over time. OMIT presents benefits over different approaches to allergy immunotherapy as a result of its focused supply and simplified administration, which helps the potential for improved adherence.
About Intrommune Therapeutics
Intrommune, devoted to enhancing and defending the lives of individuals with meals allergy, is growing the revolutionary oral mucosal immunotherapy (OMIT) remedy platform for meals allergy symptoms. OMIT is a patient-friendly answer for over 220 million folks worldwide, together with 32 million folks in the U.S., who are suffering from life-altering meals allergy symptoms. Intrommune Therapeutic’s lead product, INT301, has entered Phase 1 medical trials. All of Phase 1 outcomes together with future research are meant to assist OMIT as being a protected, efficient and handy remedy for sufferers who are suffering from peanut allergy.
For extra info on Intrommune Therapeutics, please go to http://www.intrommune.com
Contact:
Stuart Loesch
Intrommune Therapeutics
(267) 740-2905
[email protected]
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