Rigel Pharmaceuticals, Inc. has enrolled the first patient in a comparative Phase II clinical study of R112, a potential intranasal therapy for the treatment of allergic rhinitis. This trial, which is expected to enrol approximately 375 patients, will be a randomized, double-blind study comparing R112 to placebo and Beconase AQ (beclomethasone) nasal spray over a 7-day period.

Allergic rhinitis causes chronic congestion and general inflammation of the upper respiratory tract in more than 59 million people in the United States. R112 inhibits mast cell activation and thereby blocks the major pathways triggered in an allergic attack.

“The purpose of this trial is to verify the safety and efficacy of R112. We want to confirm that R112 is significantly superior to placebo for the treatment of allergic rhinitis and compare it with a nasal steroid,” Elliott B. Grossbard, senior vice president of Medical Development at Rigel said adding, “Our initial Phase II ‘Park’ study demonstrated that R112 could improve allergy symptoms, including sneezing, stuffy nose, running nose, itchy nose and throat, post nasal drip, cough, headache and facial pain, in as early as 30 minutes, whereas steroids typically take longer. Furthermore, the magnitude of effect increased over time. We are hopeful that this next study will also show that R112 could be a significant addition to current therapies.”

R112 is designed to block all of the major pathways that are triggered in an allergic attack, potentially making R112 a more effective and comprehensive drug. R112 binds to an intracellular target (syk, a kinase that regulates IgE receptor signalling) in mast cells and interrupts the signal from the IgE receptor, thus preventing cellular activation and subsequent chemical mediator release.