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Regeneron meets primary goal in phase 3 study for gout drug

Last updated: 13:59 28 Feb 2011 GMT, First published: 14:59 28 Feb 2011 GMT

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Regeneron Pharmaceuticals (NASDAQ:REGN) said Monday that it has achieved its main goals in a second phase 3 study for the company's gout drug.

The trial showed that using the company's Arcalyst drug, the mean number of gout flares, for patients who received a weekly dose of the treatment, were reduced by 72% compared to the placebo group.

The study also met all the secondary goals, as compared with placebo, treatment with Arcalyst reduced the porportion of patients who experienced at least one gout flare during the study period by 63%, using the highest dosage of the drug. The amount of patients who experienced two or more flares decreased by 82%.

Gout is a condition that occurs when the body's waste product, uric acid, is deposited in the joints and/or soft tissues, leading to inflammation which causes pain, swelling, heat and stifness in the joints. Current treatments for the disease have unpleasant side effects, including acute pain, nausea and vomiting.

"Gout, a serious and sometimes debilitating disease, is rapidly growing in prevalence throughout the world. Unfortunately, its management is often hampered by the occurrence of painful gout flares early during treatment with standard-of-care uric acid-lowering therapy," said president George D. Yancopoulos.

"With these positive Phase 3 trials in patients with gout initiating uric acid-lowering therapy, we plan to submit a supplemental Biologics License Application for U.S. regulatory approval in mid-2011."

An excess of the protein interleukin-1 (IL-1), secreted by infection-fighting cells in the blood and tissues, has been shown to be a key driver of inflammation in a number of diseases, including gout.

Arcalyst works to reduce the amount of the protein by neutralizing IL-1 before it can generate signals that trigger disease activity in body tissue, eventually eliminating it from the body.

The new investigational drug was also shown to be generally well-tolerated, with the safety profile consistent to previous studies, the company said.

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