US-based biopharmaceutical firm Receptos has started dosing patients in a Phase II trial of its development candidate RPC4046 for the treatment of eosinophilic oesophagitis (EoE).
The humanised monoclonal antibody RPC4046 is directed against interleukin-13 (IL-13), a target which has been validated in other related allergic indications including asthma.
Receptos president and chief executive officer Faheem Hasnain said: "This is a major step in the development programme for RPC4046.
"This is a disease of increasing prevalence and diagnosis for which there are no FDA-approved therapies.
"If we are successful in developing RPC4046, this would be a significant advancement in the treatment of EoE patients."
The company has a development license and option agreement with AbbVie to conduct a proof-of-concept clinical trial with RPC4046 in patients with EoE.
As part of the deal, AbbVie holds an exclusive option to enter into global co-development collaboration for RPC4046 with Receptos following results from the Phase II trial and regulatory discussions with the US Food and Drug Administration (FDA).
If AbbVie declines to exercise its co-development option, Receptos would secure a worldwide exclusive commercial license to all indications for RPC4046.
EoE is a chronic immune-mediated disease, which may be triggered by a variety of stimuli including certain foods and environmental allergens.
Patients with EoE commonly have other allergic conditions and may experience symptoms for months or years before diagnosis.
There are no FDA-approved therapies for EoE, which is typically associated with symptoms related to oesophageal dysfunction, including food impaction and difficulty swallowing.
Image: Micrograph showing eosinophilic esophagitis. Photo: courtesy of Nephron