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news.Horizon Therapeutics, a late-stage biopharmaceutical company, has announced that two pivotal Phase III trials evaluating its lead investigational product candidate, HZT-501, have met all primary endpoints.
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According to the company, HZT-501, a novel, proprietary fixed-dose combination product containing ibuprofen and famotidine, has demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric or duodenal) ulcers in patients with mild-to-moderate pain when compared to ibuprofen alone.
The Registration Endoscopic Study to Determine Ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Study (REDUCE-1 and REDUCE-2) were two randomized, double-blind, controlled trials that enrolled more than 1,500 patients in the US. The primary efficacy objective of REDUCE-1 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric ulcers during the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers.
The primary objective of REDUCE-2 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric and/or duodenal ulcers during the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers.
Patients, who had mild-to-moderate pain, including those with osteoarthritis, were randomly assigned, in approximately a 2:1 ratio, to receive HZT-501 (800mg ibuprofen and 26.6mg famotidine) or ibuprofen (800mg) alone orally three times daily for a 24-week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Patients received endoscopies at baseline and weeks eight, 16 and 24.
In REDUCE-1, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric ulcers versus treatment with ibuprofen alone. In REDUCE-2, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric and/or duodenal ulcers versus treatment with ibuprofen alone. Treatment with both HZT-501 and ibuprofen alone were well tolerated in the studies, the company said.
Timothy Walbert, president and CEO of Horizon Therapeutics, said: “NSAIDs, while highly effective in treating pain and inflammation, often lead to serious safety concerns, including significant gastrointestinal damage. We are committed to bringing this much needed treatment to physicians and patients as quickly as possible and plan on submitting these strong HZT-501 Phase III results to US and European regulatory authorities in 2009.”