Naryx Pharma, Inc. Announces Significant Results From Its Phase II Study of SPRC-AB01 in Patients With Chronic Rhinosinusitis
Posted on: Monday, 13 June 2005, 06:00 CDT
Naryx Pharma, Inc., the leader in developing new therapies for patients with chronic rhinosinusitis (CRS), announced today the successful completion of its Phase II clinical trial of SPRC-AB01, a proprietary antibiotic solution for nasal inhalation via nebulization, in post-surgical subjects with chronic rhinosinusitis. Analysis of the results indicates that statistical significance of the study's primary endpoint was achieved. There are currently no FDA-approved pharmaceutical products for the treatment of this chronic disease.
In this Phase II, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of SPRC-AB01, 58 post-surgical CRS patients were randomized to receive either placebo, low-dose SPRC-AB01 or high-dose SPRC-AB01, administered twice daily for 21 days using the PARI PRONEB Ultra compressor and PARI LC Star nebulizer with solid mouthpiece and nasal adapter attachment. Results from patients who received the high dose of SPRC-AB01 indicated a statistically significant reduction of the clinical signs and symptoms of CRS as compared to placebo at the end of therapy. All treatment groups were well balanced and adverse events were similar across placebo, low-dose SPRC-AB01 and high-dose SPRC-AB01.
"We are very pleased with both the results and the quality of the data from this Phase II clinical trial," said Robin D. Campbell, Ph.D., President and CEO. "This is the first randomized, placebo-controlled, double-blind study of an antibiotic that demonstrates a significant improvement in this seriously affected group of CRS sufferers. We look forward to continuing on our development pathway for SPRC-AB01, and believe that this novel topical therapy may offer significant relief for this group of patients."
About Naryx Pharma, Inc.
Naryx is a privately-held company dedicated to developing innovative therapies for chronic rhinosinusitis, based on advances in the targeted delivery of medications. Chronic rhinosinusitis is a disease that afflicts up to 30 million people in the United States alone. The Company will focus on obtaining marketing approvals for its promising intellectual property portfolio of intranasal drug formulations.
Source: Business Wire
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