SR1375 / Shanghai SIMR Biotech - LARVOL DELTA

Novel Therapeutic for Diabetic Kidney Disease through Targeting Lp-PLA2 in Immune Cells and Damaged Renal Parenchymal Cell (ERA 2025) - "The efficacy of the proprietary Lp-PLA2 inhibitor SR1375 on renal function were tested in a mice model of diabetic nephropathy (HFD-Unx-STZ-DKD model) and a rat model of hypertensive nephropathy (DOCA-salt-HTN model)...Conclusions Our results suggest a functional role for Lp-PLA2 in the pathogenesis of DKD, providing preclinical and clinical proof-of-concept for Lp-PLA2 inhibitors as a novel therapeutic approach for patients with DKD. A Phase 2 clinical trial in DKD patients is scheduled to be conducted in the second half of 2025."

Immune cell • Chronic Kidney Disease • Diabetic Nephropathy • Inflammation • Nephrology • Renal Disease • LA2G7

Development of SR1375, a Novel Lipoprotein-Associated Phospholipase A2 Inhibitor as an Effective Oral Drug Candidate for Pneumonia With Comorbidities (ATS 2025) - P2 | "SR1375 shows promise as a novel therapeutic option for elderly pneumonia patients with multiple comorbidities. A Phase 2 registrational clinical trial focusing on this population was initiated in China in 2024. Clinical trial web link https://clinicaltrials.gov/study/NCT06577558?term=sr1375&rank=1."

Late-breaking abstract • Acute Lung Injury • Cardiovascular • Chronic Kidney Disease • Diabetes • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • IL6 • TNFA

Efficacy and Safety of SR1375 in Adult Patients with CAP (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumonia

Efficacy and safety of SR1375 in hospitalized patients with pneumonia combined with underlying disease: a randomized, double-blind, placebo-parallel controlled trial (ERS 2024) - "On the basis of the widespread use of glucocorticoids in patients, SR1375 was still able to show modulation of key biomarkers, superior efficacy to conventional treatment (improvement in 7-category ordinal scale) and a favourable safety profile. Notably, patients in the 3 mg group had better efficacy than 10 mg when compared to the placebo group (-0.38 vs -0.06, p=0.05). In the subgroup of patients with concomitant interstitial pulmonary fibrosis, there was a trend towards a more pronounced therapeutic improvement in the 7-category ordinal scale (-0.44 vs -0.23, p=0.05)."

Clinical • Immunology • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • Systemic Inflammatory Response Syndrome

Efficacy and Safety of SR1375 in Adult Patients With CAP (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

New P2 trial • Infectious Disease • Pneumonia

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375 (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Active, not recruiting ➔ Completed

Trial completion

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Oct 2022 | Trial primary completion date: Mar 2023 ➔ Oct 2022

Trial completion • Trial completion date • Trial primary completion date

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375 (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Trial completion date: Oct 2022 ➔ Jan 2023

Trial completion date

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Jan 2023

Enrollment closed • Trial completion date • Trial primary completion date

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375 (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: SIMR (Australia) Biotech Pty Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Oct 2022

Enrollment closed • Trial completion date

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | N=32 ➔ 8

Enrollment change • Enrollment closed

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Shanghai SIMRD Biotechnology Co., Ltd.

New P1 trial

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375 (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: SIMR (Australia) Biotech Pty Ltd.; Trial completion date: Mar 2022 ➔ Jul 2022; Trial primary completion date: Mar 2022 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date