Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today presented an analysis from two pivotal Phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine. The analysis, which was designed to identify risk factors for the development of non-steroidal anti-inflammatory drug (NSAID)-associated ulcers, was presented at the 74th American College of Gastroenterology (ACG) Annual Scientific Meeting.
"Upper gastrointestinal tract ulcers develop commonly in people taking NSAIDs and can occur without warning symptoms. Historically there have been limited data identifying the factors that predict an increased risk of finding ulcers in NSAID users," said Loren Laine, MD, University of Southern California Keck School of Medicine and lead investigator. "Data collected from the REDUCE-1 and REDUCE-2 trials provide insight into these risk factors. The statistically significant independent risk factors included the use of the NSAID ibuprofen without the histamine-2 receptor antagonist famotidine, previous ulcer disease and older age."
The two pivotal Phase 3 clinical trials, REDUCE-1 and REDUCE-2 (Registration Endoscopic Studies to Determine Ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Studies), conducted via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), were randomized, double-blind, controlled trials that enrolled more than 1500 patients with mild-to-moderate pain. Patients were randomly assigned, in approximately a 2:1 ratio, to receive either HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or the NSAID ibuprofen (800 mg) alone orally three times daily for a 24-week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal (GI) ulcer and/or prohibitive toxicity. Results showed that patients with mild-to-moderate pain treated with HZT-501 developed approximately 50 percent fewer NSAID-associated upper GI ulcers compared to patients treated with ibuprofen alone.
The statistical analysis looked at the combined 1,382 patients studied in the REDUCE-1 and REDUCE-2 primary study populations (HZT-501,> Analysis Factor Relative Risk (95% CI) --------------- --------------------- Ibuprofen (without famotidine) 2.18 (1.64, 2.90) Prior ulcer 1.65 (1.01, 2.69) Age>"By identifying these independent risk factors, physicians may be able to better assess a patient's risk for NSAID-associated GI toxicity," said Timothy P. Walbert, president and chief executive officer of Horizon Therapeutics. "For patients with chronic pain who are at increased GI risk, HZT-501 may be an important treatment option."
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