Allena Pharmaceuticals Inc. (NASDAQ:ALNA) has announced the dosing of the first subject in Phase 1 clinical study of ALLN-346, an orally administered investigational urate-degrading enzyme designed to stability and activity in the gastrointestinal tract intended for hyperuricemia patients treatment with gout and advanced chronic kidney disease.
ALLN-346 designed to reduce Urate metabolic burden
Usually, hyperuricemia, which is the elevation of uric acid levels in the blood, results in insufficient secretion or overproduction of uric acid, and it is a major predisposing gout condition. The increase in uric acid excretion in urine and hyperuricemia are connected with kidney damage and kidney stone formation. Usually, CKD patients with gout and hyperuricemia don’t get optimal management because of limited therapies and dose restrictions, reduced tolerability, contraindication, and drug-drug interactions. In the US, there are around 375,000 patients with hyperuricemia and CKD.
Louis Brenner, the CEO and President of the company said that they are delighted to advance ALLN-346 to clinical trials, their second product. He said that just like reloxaliase, ALLN-346 has been designed through the company’s novel oral enzyme tech platform. The company’s objective is to create the first-ever orally administered non-absorbed stable enzyme that degraded Urate in the gastrointestinal tract. This will help in reducing urate metabolic burden of the kidney. Brenner explained that this was a compelling application for the oral enzyme platform. The company’s scientific team has continued to innovate and offer new potential treatments for patients with difficult metabolic diseases.
Trial to enroll 24 healthy volunteers
The Phase 1 ALLN-346 trial is a double-blind, randomized, controlled, single ascending dose trial, which will be conducted in 24 healthy participants. The primary endpoint of the study is assessing the safety and tolerability of ALLN-346 over four weeks. The company anticipates reporting of initial clinical data in Q4 2020.
Allena had presented preclinical proof of concept data for ALLN-346 in 2018 at the annual American College of Rheumatology meeting. The data showed urate reduction in animal models of severed hyperuricemia with kidney damage because of urate crystal deposition.