Rigel's R112 fails to improve allergic rhinitis in phase 2 trial

By Angela McDaniels

Seattle, Dec. 1 - Rigel Pharmaceuticals Inc. said its R112, a potential intranasal therapy for the treatment of allergic rhinitis, failed to show a statistically significant difference over placebo in a comparative phase 2 clinical study.

"We are disappointed in today's results," said James M. Gower, Rigel chairman and chief executive officer, in a company news release.

"These results are surprising given that the earlier phase 2 'Park' study of R112 demonstrated a statistically significant reduction in the symptoms associated with allergies."

The randomized, double-blind phase 2 study compared R112 and Beconase AQ (beclomethasone) nasal spray to placebo over a seven-day period. Treatment with R112 failed to show a significant improvement in nasal allergy symptoms over treatment with placebo, the study's primary endpoint.

Beconase AQ was superior to placebo treatment, the company said.

The study was conducted at 25 centers across the United States and enrolled 396 patients who were then randomized to a seven-day treatment cycle of twice-daily dosing of R112, placebo or Beconase AQ.

In the earlier phase 2 "Park Study" clinical trial, R112 demonstrated statistically significant efficacy in improving symptoms of allergic rhinitis, the company said, including sneezing, stuffy nose, running nose, itchy nose, itchy throat, post-nasal drip, cough, headache and facial pain. It had a rapid onset of action as early as 30 to 45 minutes over a two-day period.

In all clinical studies to date, R112 has been shown to have a favorable safety profile, the company said.

Common allergy drugs such as antihistamines or antileukotrienes block only a single mediator. Intranasal steroids are able to block multiple mediators in the allergic response, but these can have a slow onset of action and sometimes require multiple days of treatment before a positive effect is seen.

Despite the drawbacks of these treatments, the U.S. market for allergic rhinitis therapies approaches $4 billion, the company said.

Rigel, based in South San Francisco, Calif., develops small molecule drugs for the treatment of inflammatory diseases, cancer and viral diseases.

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