US-based Allena Pharmaceuticals has started its 28-day Phase II trial of ALLN-177, an orally administered recombinant oxalate-degrading enzyme, and potential treatment for hyperoxaluria and kidney stones.
Hyperoxaluria results from high oxalate levels in urine, due to a genetic defect causing hyper-absorption or overproduction of oxalate by the liver.
The Phase II trial is designed to evaluate the safety, tolerability and efficacy of ALLN-177 in reducing urinary oxalate excretion in patients with secondary hyperoxaluria.
ALLN-177 works by degrading oxalate in the gastrointestinal tract, which reduces the burden of dietary and endogenously produced oxalate.
The enzyme could reduce the oxalate deposited as calcium oxalate crystals or kidney stones, as well as calcium oxalate-related complications.
In a Phase I trial in healthy volunteers and an open-label Phase IIa trial in patients with secondary hyperoxaluria, ALLN-177 showed proof-of-concept results for the reduction of urinary oxalate excretion.
Allena Pharmaceuticals chief operating officer Louis Brenner said: "This is an important next study for our ALLN-177 clinical development programme.
"Both our Phase I and Phase IIa study results highlight the potential of ALLN-177 to help patients with oxalate disorders.
"We believe that the ongoing Phase IIb dose-ranging study and this 28-day Phase II study will together provide the necessary data to support design and initiation of the Phase III development programme in 2017."
The company is currently carrying out a Phase IIb trial evaluating multiple doses of ALLN-177 in recurrent calcium oxalate kidney stone patients with hyperoxaluria.
Allena develops and commercialises non-systemic oral protein therapeutics to treat metabolic and orphan diseases.