A trial investigating desensitisation immunotherapy delivered as toothpaste for adults with peanut allergy reached a final milestone after Intrommune Therapeutics completed the last patient’s last visit.
The Phase I OMEGA clinical trial (NCT04603300) is a multi-centre, randomised, placebo-controlled double-blind study involving splitting 32 participants with peanut allergy into two groups to receive either an escalating dose of the company’s candidate INT301 or placebo.
The primary outcome is the safety of the drug compared to placebo. Safety is measured by the percentage of participants able to tolerate the highest dose and incidence of adverse reactions.
Intrommune Therapeutics’ candidate utilises the company’s oral mucosal immunotherapy (OMIT) platform to deliver the therapy in fully functional toothpaste. OMIT’s simple administration allows for improved adherence, which is important for desensitising a patient to a specific allergy. Allergy immunotherapy requires consistent exposure.
Peanut allergy is one of the most common allergies that affects adults and children, with peanuts being one of the most common foods known to cause anaphylaxis. Currently, Aimmune Therapeutics’ Palforzia – an oral immunotherapy – is given to children to reduce the severity of anaphylaxis.
“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,” said Michael Nelson, CEO, Intrommune Therapeutics.
“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.”