PS-002 / Purespring Therapeutics - LARVOL DELTA

PS-002 for the Treatment of IgA Nephropathy in Adults (clinicaltrials.gov) - P1/2 | N=32 | Recruiting | Sponsor: Purespring Therapeutics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Gene Therapies • Glomerulonephritis • IgA Nephropathy • Renal Disease

Phase 1/2 Trial of PS-002, an Adeno-Associated Virus-Based Therapy Delivering the Complement Factor I Gene to Podocytes in IgAN (KIDNEY WEEK 2025) - "Following identification of a biologically optimal dose in the phase 1 dose exploration portion, a phase 2 dose expansion cohort will be recruited to evaluate further safety and efficacy. The trial will be conducted in the US and UK and will recruit up to 12 patients in the phase 1 exploration and 20 patients in the phase 2 expansion cohort."

P1/2 data • Chronic Kidney Disease • Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Renal Disease

PS-002 for the Treatment of IgA Nephropathy in Adults (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Purespring Therapeutics Limited

New P1/2 trial • Gene Therapies • Glomerulonephritis • IgA Nephropathy • Renal Disease

Purespring Therapeutics receives UK CTA approval for Phase I/II clinical trial of PS-002 in patients with primary IgA nephropathy (IgAN) (Yahoo Finance UK) - "Purespring Therapeutics...announces that its UK Clinical Trial Application (CTA) for a planned Phase I/II study of PS-002, Purespring’s lead programme, in patients with IgA nephropathy (IgAN) has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the NHS Health Research Authority (HRA) and Research Ethics Committee (REC)."

New P1/2 trial • IgA Nephropathy

Purespring Therapeutics announce FDA IND clearance for Phase I/II clinical trial for primary IgA nephropathy (IgAN) (Purespring Press Release) - "Purespring Therapeutics,...announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN)...The Phase I/II clinical trial is expected to initiate in Q4 2025 and will evaluate local administration of PS-002 to treat IgAN. In the Phase 1 part of the study the main read-outs will be safety parameters. The safety results, together with efficacy biomarkers, will be leveraged to select a dose for the Phase 2 part of the study, which will further define the safety profile and provide early markers of efficacy. PS-002 is designed to provide long term benefits following a single treatment. The study will recruit patients in the US and Europe."

IND • New P1/2 trial • IgA Nephropathy