Exhibit 99.1
Allena Pharmaceuticals Announces Initial Data from Phase 1 Trial of ALLN-346
— Single-Ascending Doses of ALLN-346 Oral Enzyme Well-Tolerated —
— Non-Absorption of ALLN-346 Demonstrated —
— Advancing to Phase 1b Multiple-Ascending Dose Study and Phase 2 Proof-of-Concept Trial; Initial Data from Both Studies Expected in Second Half of 2021 —
Newton, Mass., November 30, 2020 — Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and chronic kidney disease (CKD).
The double-blind, placebo-controlled, single-ascending dose study enrolled 24 healthy volunteers. Groups of eight study participants were randomized 3:1 to ALLN-346 or matching placebo in three sequential cohorts dosed orally with three, six, or 12 capsules in one day. Each capsule of ALLN-346 contained a target dose of 90 mg of enzyme, equivalent to 2,250 units. ALLN-346 was well-tolerated with no clinically significant safety signals and no dose-limiting toxicities observed in any cohort up to the highest administered dose. In addition, assay of serum samples by ELISA immunoassay demonstrated that ALLN-346 was not absorbed systemically, supporting that its mechanism of action appears to be restricted to the GI tract.
“We are very encouraged by the preliminary safety and tolerability data collected for ALLN-346 in healthy volunteers,” said Louis Brenner, M.D, President and Chief Executive Officer of Allena. “While there are several classes of approved therapies to treat hyperuricemia and gout, all have significant limitations in the CKD population due to toxicity-related concerns, dose limitations, and contraindications. We specifically designed ALLN-346 to overcome these challenges, using our proprietary platform to create a stable oral enzyme that is intended to act via the gut-kidney axis, degrading urate in the GI tract and reducing the systemic and metabolic burden of urate on the kidneys. The results announced today support our belief in ALLN-346’s gut-restricted mechanism of action and support its further development as a scientifically-driven therapeutic candidate for the approximately 375,000 people living with gout and moderate-to-severe CKD. We are now preparing to advance ALLN-346 into separate Phase 1b multiple-ascending dose and Phase 2 clinical studies, and look forward to further progress, including potential proof-of-concept data, in 2021.”
Subject to feedback from the U.S. Food and Drug Administration, Allena expects to initiate a Phase 1b multiple-ascending dose trial in healthy volunteers and a Phase 2 proof-of-concept trial in patients with hyperuricemia and CKD in the first half of 2021, with initial data from both studies expected in the second half of 2021.
About Hyperuricemia
Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction or insufficient excretion of urate, or often a combination of the two. Hyperuricemia is associated with gout, a kind of arthritis caused by excess uric acid in the blood that leads to the formation of hard crystals in the joints. Hyperuricemia can also lead to increased uric acid excretion in the urine and subsequently to kidney stone formation and kidney damage also known as urate nephropathy. In addition, hyperuricemia has been linked to hypertension, CKD, glucose intolerance, dyslipidemia, insulin resistance and obesity.
CKD patients with hyperuricemia and gout are often not optimally managed due to limitations of available therapies, including decreased tolerability, dose restrictions, drug-drug interactions, and contraindications. According to a published study, there are approximately 375,000 patients in the United States with hyperuricemia and CKD on urate lowering therapy who have uncontrolled gout.1
| 1 | Lim, J., Fu, A., Reasner, D. & Taylor, D. (2017, April). Prevalence of CKD and Uncontrolled Gout Among US Adults: Results From NHANES 2007–2012. Poster presented at the National Kidney Foundation Spring Clinical Meetings, Orlando, FL. |
