The food-allergy-focused biotech Intrommune Therapeutics is announcing that it is extending the duration of the ongoing Phase 1 OMEGA clinical trial of INT301 in adults with peanut allergy.
The alteration will lengthen the study duration to 48 weeks to include a maintenance period.
The study duration was previously 26 weeks.
The New York City–based company is also amending the study to include a double-blind placebo-controlled oral food challenge (DBPCOFC) at the end of the therapy period.
The OMEGA clinical trial design is double-blinded and placebo-controlled. The study enrolls adults with peanut allergy in a three-to-one ratio to receive escalating doses of INT301 or placebo.
INT 301 is a mucosal peanut-desensitization immunotherapy. The product is formulated as a toothpaste to be incorporated into patients’ daily oral hygiene 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, in a press release. “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.”
Almost 3% of U.S. adults have a self-reported peanut allergy, according to a 2021 article in the Journal of Allergy and Clinical Immunology. The article surmised a total of 1.8% with “convincing” peanut allergy.
In 2020, FDA approved Palforzia, a drug indicated to avoid allergic reactions, including anaphylaxis, that can occur after accidental exposure to peanuts in children with a confirmed peanut allergy diagnosis.