Allena Pharmaceuticals has started the Phase IIb dose-ranging study of ALLN-177 for secondary hyperoxaluria.
ALLN-177 is an orally administered recombinant oxalate-degrading enzyme being developed for the chronic management of hyperoxaluria and kidney stones (nephrolithiasis).
Hyperoxaluria is a condition that results from high oxalate levels in the urine due to either hyper-absorption of oxalate from the diet (secondary) or from overproduction of oxalate by the liver (primary) due to a genetic defect.
The Phase IIb randomised and crossover study has been designed to assess the safety, tolerability, and efficacy of three different doses of ALLN-177 to reduce urinary oxalate excretion in patients with secondary hyperoxaluria.
Allena Pharmaceuticals COO Dr Louis Brenner said: "Allena has made significant recent progress with the advancement of our ALLN-177 clinical programme and with the addition of Dr Annamaria Kausz to our management team.
"Our Phase I and Phase IIa study results highlight the potential of ALLN-177 to help patients with oxalate disorders, and we are fortunate to secure Annamaria's leadership for our clinical development organisation."
According to Allena, earlier completed studies, including Phase I trial in healthy volunteers and Phase IIa trial in patients with secondary hyperoxaluria, have showed proof-of-concept for the reduction of urinary oxalate excretion using ALLN-177.
ALLN-177 is said to target oxalate in the gastrointestinal tract that will help to reduce the burden of both dietary and endogenously produced oxalate.
It holds the capability 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.