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. W…