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Clinical Trials

Date: 2016-02-10

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: Allena Pharmaceuticals (USA - MA)

Product: ALLN-177

Action mechanism: protein/enzyme. ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme in development for the chronic management of hyperoxaluria and kidney stones (nephrolithiasis). ALLN-177 targets oxalate in the gastrointestinal tract, in an effort to reduce the burden of both dietary and endogenously produced oxalate. ALLN-177 has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the incidence of calcium oxalate related complications. Effective management of hyperoxaluria could reduce long-term kidney complications, as well as the number of interventions required for the management of kidney stones.

Disease: secondary hyperoxaluria

Therapeutic area: Kidney diseases - Renal diseases

Country: USA

Trial details: This Phase 2 multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria. (NCT02547805)

Latest news: • On February 10, 2016, Allena Pharmaceuticals announced that patient treatment has commenced in its 28-day Phase 2 study of ALLN- 177, an orally administered recombinant oxalate-degrading enzyme being developed for the management of hyperoxaluria and kidney stones. Previously completed studies, including a Phase 1 trial in healthy volunteers and an open-label Phase 2a trial in patients with secondary hyperoxaluria , have demonstrated proof-of-concept for the reduction of urinary oxalate excretion using ALLN-177.

Is general: Yes