8:01a ET 7/19/2022 - Benzinga
| Mentioned: | ALNA |
Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to treat metabolic diseases, today reported completion of enrollment of the first two cohorts of its ALLN-346 Phase 2a Study 202 in gout patients with stage 2 (cohort A) and stage 3 (cohort B) chronic kidney disease (CKD). ALLN-346, which has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), is a first-in-class, non-absorbed, orally administered enzyme in development for the treatment of hyperuricemia and gout in the setting of advanced CKD, an indication with high unmet need. ALLN-346 is a bio-engineered enzyme specifically designed to degrade urate in the gastrointestinal tract without systemic absorption and thereby reduce systemic urate levels in patients with hyperuricemia, gout and CKD.
Study 202 is a two-week, outpatient study assessing safety and tolerability in hyperuricemic patients with gout and CKD. Patients are randomized (2:1) to receive either five capsules of ALLN-346 or a matching placebo three times daily, with enrollment of up to four planned cohorts, each consisting of up to 12 patients. Cohort A has enrolled seven patients with an estimated glomerular filtration rate (eGFR) of 60-89 mL/minute (considered to have Stage 2, or mild CKD), and Cohort B has enrolled twelve patients with an eGFR of 30-59 mL/minute (considered to have Stage 3, or moderate CKD). Of note, because Study 201, a one-week inpatient study conducted at a clinical pharmacology unit, has enrolled primarily hyperuricemic patients with Stage 2 CKD, targeted enrollment of Stage 2 CKD patients in Cohort A of Study 202 was reduced from twelve to seven. Topline safety and efficacy data from cohort A and cohort B of Study 202 are expected to be available later this quarter. Pending review of the Phase 2a data and the availability of sufficient financial resources, the Company expects to open two additional cohorts later this year, consisting of gout patients with Stage 4, or advanced CKD (Cohort C) and an allopurinol combination therapy cohort in gout patients with Stage 3 CKD (Cohort D).
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