Date: 2015-08-04
Type of information: Treatment of the first patient
phase: 2b
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: Rare diseases - Metabolic diseases
Country:
Trial
details: The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones. (NCT02503345)
Latest
news: * On August 4, 2015, Allena Pharmaceuticals, a specialty biopharmaceutical company focused on developing and commercializing innovative, non-systemic, oral protein therapeutics to treat metabolic and orphan diseases, announced that the first patient has been treated in its Phase 2b dose-ranging study of ALLN-177, an orally administered recombinant oxalate-degrading enzyme being developed for the chronic management of hyperoxaluria and kidney stones. The Phase 2b randomized, crossover study will evaluate the safety, tolerability and efficacy of three different doses of ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria. ALLN-177 degrades 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. Previously completed studies, including a Phase 1 trial in healthy volunteers and a Phase 2a trial in patients with secondary hyperoxaluria, (NCT02289755) have demonstrated proof-of-concept for the reduction of urinary oxalate excretion using ALLN-177.
