Aimmune Therapeutics has recruited the first patient in a Phase II clinical trial evaluating investigational biological drug AR201 for the treatment of egg allergy.
Egg allergy is common and can cause severe hypersensitivity reactions, including life-threatening anaphylaxis. The condition affects around six million people globally, including four million across Asia and 800,000 in the US.
It currently lacks approved therapies, though rescue medications such as epinephrine auto-injectors are used in some cases.
Based on the company’s Characterized Oral Desensitization ImmunoTherapy (CODIT) platform, AR201 is intended for oral immunotherapy in egg allergy.
The randomised, double-blind, placebo-controlled Phase II trial will investigate the safety and efficacy of the drug candidate for desensitisation in 84 hen egg allergy patients aged four to 26 years at 15 US sites.
Participants experiencing dose-limiting allergy symptoms with single ≤300mg doses of dried egg white protein during a double-blind, placebo-controlled food challenge (DBPCFC) will be enrolled into the study.
Dosing regimens will involve initial low doses, followed by gradual dose escalation for limiting allergic reaction and fixed 300mg/day therapeutic dose of dried egg white protein.
The trial’s primary efficacy endpoint is the proportion of patients who can tolerate a single dose of at least 1,000mg dried egg white protein with only mild allergy symptoms at the exit DBPCFC.
In addition, secondary efficacy endpoints include the proportion of patients who tolerate a single highest dose of at least 300mg and 600mg dried egg white protein.
The trial will also measure the maximum severity of allergy symptoms caused by the consumption of dried egg white protein during the exit DBPCFC.
Aimmune president and CEO Jayson Dallas said: “In developing AR201, we hope to help alleviate the constant fear of accidental exposure, which can have a significant negative impact on quality of life for egg-allergic patients and their families.”
The company signed an agreement with Michael Foods for the supply and use of egg products.