Allena Pharmaceuticals Inc. (NASDAQ:ALNA) has announced results for its phase 1 clinical study of ALLN-346 in healthy subjects. ALLN-346 is the company’s experimental, oral, novel urate-degrading enzyme designed for stability and activity in the gastrointestinal tract for hyperuricemia treatment in patients having chronic kidney disease (CKD) and gout.
ALLN-346 shows favorable tolerability and safety profile
The company enrolled 24 healthy volunteers in the single-ascending dose, placebo-controlled, double-blind study. The study randomized participants 3:1 to either ALLN346 or placebo group in three cohorts that received oral doses of three, six, and 12 capsules per day. ALLN-346 showed favorable tolerability without any clinically significant safety indications or dose-limiting toxicities in the group that received the highest dose.Also, the ELISA immunoassay assay of serum samples showed unsystematic absorption of ALLN-346 thus supporting the hypothesis that its action mechanism seems restricted in the gastrointestinal tract.
Allena CEO and President, Louis Brenner stated that the tolerability and preliminary safety data from the study of ALLN-346 in healthy individuals were encouraging. Although there are several approved therapy classes for gout and hyperuricemia treatment, all have substantial limitations in the chronic kidney disease population because of dose limitations, toxicity-related concerns, and contraindications. Brenner said that the company designed ALLN-346 to overcome the challenges through its proprietary platform by creating a stable oral enzyme that acts via the kidney-gut axis. It acts by degrading urate and reducing metabolic and systemic urate burden on kidneys.
Allena provided an update on the reloxaliase study
Recently the company reported its Q3 2020 financial results and offered a corporate update. Brenner said that the company made progress during the quarter across its portfolio. Already Allena is enrolling in the URIROX-2, reloxaliase study in EH patients. The company presented data across its reloxaliase clinical development program at this year’s virtual ASN meeting. The data highlighted reloxaliase’s consistency, clinically significant impact on urinary oxalate excretion (UOx) as well as reinforces the company’s conviction that the novel therapeutic could potentially change the EH treatment paradigm. Brenner said that following the company’s debt financing it has adequate capital to advance its programs.