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Allena Pharmaceuticals Surges 108%, Leads Biotech Gainers ($ALNA)

Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) shares are soearing by more than 108% on Thursday. Investors may be responding to a prior clinical and corporate update. the company said:

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 Q1 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 today 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 topline data on sUA from patients in the first cohort during the one-week treatment period are shown graphically below:

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 Q1 2022, Allena currently expects to open two additional cohorts during Q2 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).

Robert Terkeltaub, M.D., Professor of Medicine, Division of Rheumatology, Allergy and Immunology, UC San Diego stated, “In CKD patients, gout treatment regimens are extremely challenging based on tolerability limitations, dosing restrictions, contraindications, and drug-drug interactions. Because ALLN-346 works via a novel mechanism tailored to take advantage of the gut-kidney axis for uric acid elimination, it offers the potential for a favorable safety profile that could prove valuable in adding to our pharmacologic toolkit for managing the complex patients we see with gout and comorbid moderate to severe CKD. I am encouraged by the proof of pharmacology concept studies in Stage 2 CKD patients to date. I look forward to reviewing additional data as future clinical trial results emerge.”

David S. Goldfarb, M.D., Professor of Medicine and Physiology and Clinical Chief of Nephrology at NYU Langone Medical Center, added, “Hyperuricemia and the resulting clinical manifestations of gout represent a progressive and challenging metabolic derangement for CKD patients, especially as kidney function decreases. ALLN-346 acts by a novel gut-restricted mechanism, which is conceptually similar to currently available agents used to treat excesses of phosphorus and potassium via the GI tract in CKD patients. I am encouraged by this initial data in hyperuricemic patients and look forward to seeing additional data from the Phase 2a program in patients with more advanced CKD, since these patients are especially susceptible to a higher risk of morbidity and complications associated with gout and worsening CKD.”

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