Allena Pharmaceuticals, Inc. provided a clinical and corporate update. ALLN-346 Program: ALLN-346 is a first-in-class, non-absorbed, orally administered enzyme in development for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease (CKD). In November, ALLN-346 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

The Company is conducting two Phase 2a trials of ALLN-346: Study 201, a one-week inpatient study being conducted at a clinical pharmacology unit, and Study 202, a two-week outpatient study being conducted at 20 sites across the U.S. In Study 201, patients with hyperuricemia are being randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo three times daily for one week. Planned enrollment in the trial consists of two cohorts, each with approximately 12 patients. Of the 11 patients in the first cohort, seven received ALLN-346 and four received placebo.

The majority of these patients had Stage 2 CKD, including five of the seven subjects treated with ALLN-346. The second cohort is currently being enrolled with topline data expected in first quarter 2022. Data from the first cohort demonstrated a statistically significant reduction in serum uric acid (sUA) from baseline (p<0.05) in patients treated with ALLN-346 compared to placebo.

Consistent with the known pathophysiologic adaptation of increased intestinal elimination of uric acid in patients with impaired kidney function and the GI-based mechanism of action of ALLN-346, there was a strong correlation between the effect of ALLN-346 on sUA reduction and the level of kidney function (correlation coefficient r=0.95; p=0.003). The positive data announced support proof of pharmacology for the gastrointestinal (GI) mechanism of action of ALLN-346. In the first cohort, ALLN-346 was well-tolerated with no serious adverse events.

The second Phase 2a trial of ALLN-346, Study 202, is a two-week, outpatient study designed to enroll hyperuricemic patients with gout and CKD. Patients are being 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 approximately 12 patients. Cohort A is currently enrolling patients with an estimated glomerular filtration rate (eGFR) of 60-89 mL/minute (considered to have Stage 2, or mild CKD), and cohort B is currently enrolling patients with an eGFR of 30-59 mL/minute (considered to have Stage 3, or moderate CKD).

Topline safety and efficacy data from each of these two cohorts of Study 202 is expected to be available in the first quarter of 2022. Subject to a planned protocol amendment and securing adequate additional financing in First Quarter 2022, Allena currently expects to open two additional cohorts during Second Quarter 2022, consisting of patients with Stage 4 or advanced CKD (Cohort C) and an allopurinol combination therapy cohort in Stage 3 CKD patients (Cohort D).