Intrommune Therapeutics, a clinical-stage biotech company, announced it had achieved Last Patient, Last Visit status for its phase 1 OMEGA clinical trial of INT301, a toothpaste designed to treat peanut allergy.
Last Patient, Last Visit means the final clinical trial subject has completed their last visit to the treating physician required by the protocol, thus ending the data collection phase of the trial. The company will now analyze the data with results to be presented in Q4.
INT301 is a novel immunotherapy administered as a fully-functional toothpaste designed to desensitize the patient to peanuts during their daily toothbrushing routine. The process known as Oral Mucosal Immunotherapy (OMIT) does not involve ingesting the allergen.
Said Michael Nelson, CEO of Intrommune Therapeutics:
Achieving Last Patient Last Visit 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. We are encouraged that based on the blinded data review to date, patients enrolled in our OMEGA Clinical Study experienced only transient drug-related adverse events, with no serious adverse events or anaphylaxis, and no use of emergency epinephrine. We expect to present the full safety and efficacy results in the fourth quarter of this year.
OMEGA is a randomized, double-blind, placebo-controlled study that enrolls adults with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or a placebo. The study groups are blinded to the investigator, patients, and the Intrommune study team. Last year, the FDA allowed amendments to the OMEGA Clinical Study protocol to determine the maximally tolerated dose and to allow the addition of a maintenance period which included a DBPCOFC at the end of the trial.