ABP-671 / Jiangsu Atom Bioscience and Pharma - LARVOL DELTA

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Dose of ABP-671 in Participants with Chronic Kidney Disease (CKD) (ACR Convergence 2024) - "It is concluded that no dose adjustment is required to achieve comparable UA clearances in all cohorts studied, when treated with 2 mg QD. ABP-671 appeared generally safe and well tolerated in participants with normal kidney function and CKD. There were no deaths, serious, or severe TEAEs reported, and no participants were discontinued from the study due to TEAEs."

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

ABP-671-302: Extension Study of ABP-671 in Participants With Gout (clinicaltrials.gov) - P2/3 | N=43 | Terminated | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | N=580 ➔ 43 | Trial completion date: Jul 2025 ➔ Sep 2024 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Sep 2024; Redesign of clinical development program for ABP-671: A new long-term safety study after the completion and analysis of Part 1 of ABP-671-301 (NCT05818085) is planned and will be conducted using the doses selected for the pivotal studies.

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

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2/3 | N=580 | Active, not recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2/3 | N=580 | Active, not recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gout • Inflammatory Arthritis • Rheumatology

Extension Study of ABP-671 in Participants With Gout (clinicaltrials.gov) - P2/3 | N=580 | Enrolling by invitation | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

New P2/3 trial • Gout • Inflammatory Arthritis • Rheumatology

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2/3 | N=580 | Recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Phase classification: P2b ➔ P2/3

Phase classification • Gout • Inflammatory Arthritis • Rheumatology

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2b | N=580 | Recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Inflammatory Arthritis • Rheumatology

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2b | N=580 | Not yet recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Initiation date: May 2023 ➔ Aug 2023

Trial initiation date • Gout • Inflammatory Arthritis • Rheumatology

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia (clinicaltrials.gov) - P2a | N=60 | Completed | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Monotherapy • Trial completion • Gout • Inflammatory Arthritis • Rheumatology

Phase 2b/3 Study to Assess Efficacy and Safety of ABP-671 a Novel URAT1 Inhibitor in Participants With Gout (clinicaltrials.gov) - P2b | N=580 | Not yet recruiting | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

New P2b trial • Gout • Inflammatory Arthritis • Rheumatology

A Double-Blind, Placebo-Controlled, Ascending Dose Phase 2a Study of ABP-671, a Novel, Potent and Selective URAT1 Inhibitor, in Patients with Gout or Hyperuricemia (ACR Convergence 2022) - "ABP-671 induced stable, statistically significant and clinically meaningful decreases in sUA levels at all doses tested compared to placebo and baseline. At the end of the respective dose evaluation periods, an average of 87% of the ABP-671 participants attained target sUA level of < 6 mg/dL, compared to 0% of placebo participants. ABP-671 was well tolerated, without evidence of dose limiting toxicity."

Clinical • P2a data • Gout • Inflammatory Arthritis • Nephrology • Renal Calculi • Rheumatology

A Double-Blind, Placebo-Controlled, Ascending Dose Phase 2a Study of ABP-671, a Novel, Potent and Selective URAT1 Inhibitor, in Patients with Gout or Hyperuricemia (ACR Convergence 2022) - "ABP-671 induced stable, statistically significant and clinically meaningful decreases in sUA levels at all doses tested compared to placebo and baseline. At the end of the respective dose evaluation periods, an average of 87% of the ABP-671 participants attained target sUA level of < 6 mg/dL, compared to 0% of placebo participants. ABP-671 was well tolerated, without evidence of dose limiting toxicity."

Clinical • P2a data • Gout • Inflammatory Arthritis • Nephrology • Renal Calculi • Rheumatology

Jiangsu Atom Bioscience & Pharmaceutical Co., Ltd. (BIO 2022) - "Our lead development program is ABP-671, a second generation URAT1 inhibitor for treatment of gout...Atom Bioscience has raised ove $87 million to date including a Series C round for $47 million which was completed in Dec. 2021."

Gout • Hepatology • Inflammation • Inflammatory Arthritis • Non-alcoholic Steatohepatitis • Rheumatology

Atom Bioscience Announces Positive Phase 2a Results For Investigational New Drug to Treat Chronic Gout (Businesswire) - P2a | N=60 | APB-671 (NCT04638543) | Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. | "'This very encouraging Phase 2 data could be a future breakthrough treatment for gout patients who have limited treatment options right now,' said Dr. Kenneth Saag..."

P2a data

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Clinical • Monotherapy • New P2a trial • Gout • Inflammatory Arthritis • Rheumatology

Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion • Gout • Rheumatology

Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Clinical • New P1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 (clinicaltrials.gov) - P1b; N=27; Completed; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 (clinicaltrials.gov) - P1b; N=30; Recruiting; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Clinical • New P1 trial

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion