The drug AR101 is an oral immunotherapy (OIT) for the desensitisation of patients with peanut allergies. It is currently being examined in Phase III clinical studies.
Aimmune spokesperson Stephanie Yao told Biopharma-Reporter that while OIT can prevent reactions to accidental exposure to allergens, it does not treat the underlying cause of peanut allergy.
“While OIT generally does not cure a patient of his or her allergy, it can provide protection from food allergens at a level that exceeds the amount typically encountered in an accidental exposure,” said Yao.
“For many patients, this protection meaningfully decreases their stress and anxiety and enables them to lead a more normal life,” she said.
AR101 will be produced at the Clearwater-based, 20,000 square foot cGMP manufacturing facility, in preparation for potential regulatory approvals.
AR101
Aimmune’s characterised oral desensitisation immune therapy (CODIT) approach is intended to achieve meaningful levels of protection by desensitising patients with defined, precise amounts of key allergens.
Maintaining desensitisation can only be achieved by taking the drug long-term.
“Oral desensitisation works by gradually shifting the balance of the immune system to dampen the allergic response in the case of accidental exposure,” said Yao.
Aimmune’s initial target patient population for AR101 is children and adolescents in the 4-17 age group, for which it has received Fast Track and Breakthrough Therapy Designations.
Subject to regulatory approval, Aimmune intends to commercialise AR101 in the US and Europe.
Nut and egg allergies
Yao told us the company is examining programs to treat additional common food allergies.
“Leveraging the expertise we have gained developing AR101, we have done work to support the filing of an Investigational New Drug application for a product candidate for the treatment of egg allergy,” she said.
“We also have initiated pre-clinical development of a product candidate for the treatment of tree nut allergy,” she told us.
The firm is also researching combined allergy treatments.
“In an effort to help the patient population with multiple food allergies, we are also researching therapies that take a combination approach to desensitisation,” said Yao.