engineered urate oxidase (ALLN-346) / Allena Pharma - LARVOL DELTA

Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease (clinicaltrials.gov) - P2a | N=19 | Terminated | Sponsor: Allena Pharmaceuticals | Recruiting ➔ Terminated; Company Financing

Trial termination • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201) (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Allena Pharmaceuticals | Recruiting ➔ Completed | N=24 ➔ 16

Enrollment change • Trial completion • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

A high-performance electrochemical biosensor using an engineered urate oxidase. (PubMed, Chem Commun (Camb)) - "We constructed a high-performance biosensor for detecting uric acid by immobilizing an engineered urate oxidase on gold nanoparticles deposited on a carbon-glass electrode. This biosensor showed a low limit-of-detection (9.16 nM), a high sensitivity (14 μA/μM), a wide range of linearity (50 nM-1 mM), and more than 28 days lifetime."

Journal

Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Allena Pharmaceuticals | Recruiting ➔ Completed | N=24 ➔ 12 | Trial completion date: Dec 2022 ➔ Feb 2022 | Trial primary completion date: Dec 2022 ➔ Feb 2022

Enrollment change • Preclinical • Trial completion • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Allena Pharmaceuticals | Trial completion date: Apr 2022 ➔ Dec 2022 | Trial primary completion date: Apr 2022 ➔ Dec 2022

Preclinical • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

SAFETY AND EFFICACY OF ALLN-346 ORAL ENZYME THERAPY IN PATIENTS WITH HYPERURICEMIA AND CHRONIC KIDNEY DISEASE (CKD): RESULTS OF THE PHASE 2A STUDY 201 (EULAR 2022) - P2 | "In this study, oral therapy with ALLN-346 for 7 days was well tolerated and resulted in a significant reduction in sUA. Consistent with the known pathophysiologic adaptation of increased intestinal elimination of uric acid in patients with impaired kidney function and the intestinal-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. The generated data support proof of pharmacology for the intestinal mechanism of action of ALLN-346 to degrade urate either formed or secreted in the gut."

Clinical • P2a data • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

PHASE 1 TRIALS OF NOVEL ORAL ENZYME THERAPY (ALLN-346) FOR HYPERURICEMIA & GOUT: SAFETY, PHARMACODYNAMICS, AND LACK OF SYSTEMIC ABSORPTION OF SINGLE AND MULTIPLE ASCENDING DOSES IN HEALTHY VOLUNTEERS (EULAR 2022) - P1 | "ALLN-346, a new oral enzyme therapy in development for the treatment of hyperuricemia and gout in advanced CKD was well tolerated. Consistent with its mechanism of action, no evidence of systemic absorption was demonstrated. Furtherstudies in hyperuricemia patients with gout and CKD are underway."

Clinical • P1 data • PK/PD data • Chronic Kidney Disease • Gout • Hematological Disorders • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Allena Pharmaceuticals

Clinical • New P1 trial • Preclinical • Gout • Inflammatory Arthritis • Rheumatology

Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease (clinicaltrials.gov) - P2a; N=24; Recruiting; Sponsor: Allena Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201) (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Allena Pharmaceuticals

New P2 trial • Gout • Inflammatory Arthritis • Rheumatology

Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease (clinicaltrials.gov) - P2a; N=24; Not yet recruiting; Sponsor: Allena Pharmaceuticals

New P2a trial • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology

ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Allena Pharmaceuticals; Not yet recruiting ➔ Completed

Trial completion • CRP

MAD: Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase) (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Allena Pharmaceuticals; Not yet recruiting ➔ Completed

Clinical • Trial completion • Gout • Inflammatory Arthritis • Rheumatology

MAD: Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase) (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Allena Pharmaceuticals

New P1 trial • Gout • Inflammatory Arthritis • Rheumatology

Oral Treatment With an Engineered Uricase, ALLN-346, Reduces Hyperuricemia, and Uricosuria in Urate Oxidase-Deficient Mice. (PubMed, Front Med (Lausanne)) - "Fractional excretion of uric acid (FEUA) was normalized with ALLN-346 therapy. Oral enzyme therapy with engineered urate oxidase (ALLN-346) designed to degrade urate in the intestinal tract has the potential to reduce hyperuricemia and the renal burden of filtered urate in patients with hyperuricemia and gout with and without CKD."

Journal • Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Calculi • Renal Disease • Rheumatology • Urolithiasis

Allena Pharmaceuticals Inc. (NASDAQ:ALNA) Reports ALLN-346 Study Data And Update On Reloxaliase Study (BioPharma Journal) - P1, N=24; NCT04236219; Sponsor: Allena Pharmaceuticals; "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."

P1 data • Chronic Kidney Disease • Gout • Renal Disease

ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Allena Pharmaceuticals; Phase classification: P1/2 ➔ P1; N=66 ➔ 24; Trial completion date: Aug 2021 ➔ Oct 2020; Trial primary completion date: Jul 2021 ➔ Oct 2020

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • CRP

Key studies highlighted: 2 industry veterans discuss their favorite annual meeting abstracts (The Rheumatologist) - "'We would like to reassure everyone that our choices were not influenced by the College, industry or people we shoot pool with,' Dr. Cush said....Finally, Dr. Kavanaugh noted the study, 'Individually Tailored Predictions of Flare Probability for Rheumatoid Arthritis Patients on Biologic DMARDs Based on Machine Learning Stacking Meta-Classifier.'....'If there's a theme at this [Annual Meeting], it seems to be a focus on the trend toward artificial intelligence and machine learning,' Dr. Kavanaugh said. 'Almost every third poster is covering it. And I understand why. There's too much data to wade through to make it meaningful. Machines can recognize patterns.'"

Media quote

Safety, Tolerability and Efficacy of ALLN-346 in Healthy Volunteers and Patients With Hyperuricemia (clinicaltrials.gov) - P1/2; N=66; Not yet recruiting; Sponsor: Allena Pharmaceuticals

Clinical • New P1/2 trial