SAP001 / Shanton Pharma - LARVOL DELTA

Shanton Pharma Completes EOP2 Meeting with US FDA for Refractory Gout Program (PRNewswire.co.uk)

FDA event • Gout

Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program (ACROFAN) - "Shanton Pharma...announced that FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy...FDA's decision to grant the Fast Track designation for SAP-001 was based in part on Shanton's recent efficacy and safety outcomes in a Phase 2b clinical study in which SAP-001 demonstrated the potential to meaningfully improve on currently available Urate Lowering Therapy for refractory gout patients."

Fast track • Gout

SAP-001, A First –in-Class Compound Targeting a Renal Urate Transporter, Shows Potent Serum Urate-Lowering Effects and Favorable Safety Profile in a US Phase 2b Study in Patients with Refractory Gout with or without Palpable Tophi (EULAR 2025) - "The majority of the subjects were male, obese, and on background SOC treatment (more than 90% with either 100 mg, or 300 mg allopurinol for ≥3 months, and with sUA above 7 mg/dL during screening in all patients). Among patients exposed to study drug, SAP-001 demonstrated robust, sustained urate-lowering effect in refractory gout patients with or without palpable tophi. A first in class inhibitor of a distinct renal urate transporter, SAP-001 may offer a mechanistically novel, effective and safe oral ULT drug for difficult- to-treat gout populations."

Clinical • Late-breaking abstract • P2b data • Anemia • Cardiovascular • Gout • Hematological Disorders • Inflammatory Arthritis • Nephrology • Obesity • Pain • Renal Disease • Rheumatology

Shanton Reveals Topline Data from Phase 2b Study in Refractory Gout Patients (PRNewswire) - P2b | N=87 | NCT05690204 | Sponsor: Shanton Pharma Pte. Ltd. | "Shanton Pharma...announced topline data of a Phase 2b study in refractory gout patients with its investigational drug SAP-001 that uses a First-in-Class Mechanism of Action targeting a distinct kidney transporter....'By the end of month 3 in our study, nearly 100% of patients that were confirmed exposed to daily SAP-001 30 and 60 mg dosages on top of conventional therapy reached the study's therapeutical target (serum uric acid levels below 6mg/dL), compared to only about 10% of patients on conventional treatment who reached that goal. The majority of treatment effects persisted until the end of treatment at month 6 of the study. More than half of those patients confirmed exposed to a daily 60 mg dose reached serum uric acid levels below 3mg/dL. Importantly, the study demonstrated an excellent safety profile in this population'."

P2b data • Gout

PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function (clinicaltrials.gov) - P1/2 | N=32 | Active, not recruiting | Sponsor: Shanton Pharma Pte. Ltd.

New P1/2 trial • Gout • Inflammatory Arthritis • Rheumatology

Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. (clinicaltrials.gov) - P2 | N=87 | Active, not recruiting | Sponsor: Shanton Pharma Pte. Ltd. | Completed ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Shanton Pharma Co., Ltd. | Trial completion date: Sep 2024 ➔ Jan 2024

Trial completion date • Gout • Inflammatory Arthritis • Rheumatology

Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. (clinicaltrials.gov) - P2 | N=87 | Completed | Sponsor: Shanton Pharma Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Shanton Pharma Co., Ltd. | Phase classification: P2b ➔ P2 | Trial completion date: Feb 2024 ➔ Jan 2025 | Trial primary completion date: Nov 2023 ➔ Dec 2024

Combination therapy • Phase classification • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Phase 2B Double Blind, Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. (clinicaltrials.gov) - P2b | N=80 | Recruiting | Sponsor: Shanton Pharma Co., Ltd.

Combination therapy • New P2b trial • Gout • Inflammatory Arthritis • Rheumatology

Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients (clinicaltrials.gov) - P2; N=40; Completed; Sponsor: Shanton Pharma Co., Ltd.; Recruiting ➔ Completed; N=60 ➔ 40

Clinical • Enrollment change • Trial completion • Gout • Inflammatory Arthritis • Rheumatology • CXCL8 • IL1B • IL6 • TNFA

[VIRTUAL] Critically evaluating the many voices of science in the disinformation era (ACS-Fall 2021) - "The first-year course ISAP1001 introduces students to interdisciplinarity and science communication...It also shows students how information, disinformation, and the use of deep fakes can spread through and impact society. This underscores the importance of ethical information use and how students can find credible sources of information in their research while combatting the spread of disinformation."

CNS Disorders • Developmental Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Psychiatry

Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Shanton Pharma Co., Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • CXCL8 • IL6

Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Shanton Pharma Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2019 ➔ Oct 2019

Clinical • Enrollment closed • Trial completion date

Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Shanton Pharma Co., Ltd.

Clinical • New P1 trial

Placebo Controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Shanton Pharma Co., Ltd.

Clinical • New P2 trial