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Allena Pharmaceuticals completes animal proof-of-concept study for ALLN-346.

Allena Pharmaceuticals announced the completion of an animal proof-of-concept study supporting the selection of ALLN-346 as its lead product candidate for the treatment of hyperuricemia in patients with gout and associated chronic kidney disease. Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction and/or insufficient excretion of uric acid. Hyperuricemia is the major predisposing condition for gout, a disease that most commonly manifests with acute flares of arthritis, and can also lead to chronic arthritis and joint damage and palpable deposits of urate crystals in the skin. Hyperuricemia and increased uric acid excretion in the urine are also associated with kidney stone formation and kidney damage. ALLN-346 is an orally administered, novel urate oxidase that has been optimized for stability in the gastrointestinal tract. This proprietary enzyme was designed by Allena to degrade urate in the GI tract and in turn, reduce the urate burden on the kidney and lower the risk of urate-related complications. ALLN-346 is targeted to lower serum uric acid in patients with CKD, who have decreased renal function and diminished capacity for urinary excretion of uric acid. ALLN-346 has demonstrated a robust reduction in both plasma and urine uric acid levels in an established urate oxidase knock-out mouse model, a severe animal model of hyperuricemia with advanced CKD and kidney damage due to urate crystal deposition. Allena expects to present detailed preclinical data for ALLN-346 at a scientific conference in the second half of 2018. Based on the results of this study, Allena is scaling its manufacturing processes and production yield to support customary toxicology and additional preclinical studies and, consistent with prior guidance, expects to file an IND with the U.S. Food and Drug Administration in the first half of 2019.

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Publication:The Fly
Date:Jun 19, 2018
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