ANAHEIM, California — A specially formulated toothpaste (INT301, Intrommune Therapeutics) met its safety endpoints as an oral immunotherapy to help adults with peanut allergy reduce their reaction risk, according to findings of a phase 1 study.
The 48-week, randomized, double-blind, placebo-controlled trial enrolled 32 adults aged 18–55 with peanut allergy to receive in a 3:1 ratio either an escalating dose of INT301 (a preset metered dose of formulated toothpaste containing peanut protein) or placebo paste.
The primary endpoint was safety, measured by the percentage of participants who could consistently tolerate the highest dose specified in the protocol and by the incidence of systemic and nonsystemic adverse reactions.
"INT301 demonstrated safety across all treatment groups," said the study's lead author, William Berger, MD, MBA, an allergist and consultant for Intrommune, a biotechnology company based in New York City.
Berger presented findings of the OMEGA (Oral Mucosal Escalation Goal Assessment) trial on November 11 in a late-breaking abstract session at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting.
All Tolerated the Highest Dose
Study participants had to undergo skin prick testing that demonstrated a minimum wheal diameter of 3 mm greater than control and/or a peanut-specific IgE level of at least 0.35 kU/L. Additionally, participants had to have failed an oral food challenge of 100 mg or less of peanut protein.
