Purespring Therapeutics announce FDA IND clearance for Phase I/II clinical trial for primary IgA nephropathy (IgAN)

PS-002, Purespring’s lead precision nephrology programme, targets the complement pathway known to be a driver of IgA nephropathy

IND clearance follows the granting of European Medicine Agency (EMA) orphan drug designation in April 2025

First patient expected to be enrolled in 2025

London, UK – 9 July 2025 – Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today 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).

PS-002 is Purespring’s lead programme developed to target the underlying cause of many kidney diseases by modulating complement activation in the kidney via precision targeting of podocytes. The programme is initially focused on the treatment of IgAN, a rare and chronic autoimmune kidney disease that primarily affects young adults. In IgAN aberrant immunoglobin A (IgA) protein becomes trapped in the kidney’s filters, known as the glomeruli, causing complement activation, inflammation, damage and scarring. A significant proportion of affected patients will go on to develop kidney failure despite currently available therapies.

“IND clearance marks a significant milestone for Purespring as we pioneer the future of kidney care, enabled by our scalable drug delivery platform. Our precision approach targets kidney disease at its root cause – delivering the treatment directly to the podocyte,” commented Haseeb Ahmad, Purespring’s Chief Executive Officer. “By doing so, we aim to move beyond systemic therapies to specifically kidney targeted therapeutics and provide durable disease-modifying treatments for patients.”

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.

Earlier this year, Purespring announced that the European Medicines Agency (EMA) had granted orphan drug designation to PS-002 for the treatment of patients with IgAN. This designation followed the presentation of new preclinical data on IgAN at the American Society of Nephrology (ASN) Kidney Week congress in San Diego (abstract #SA-OR63).

For further information, contact:

Purespring

Peter Mulcahy
contact@purespringtx.com
+44 (0)20 3855 6324
LinkedIn

ICR Healthcare
Amber Fennell, Sarah Elton-Farr
purespring@icrhealthcare.com

About Purespring

Purespring is developing therapies to halt or prevent kidney disease, one of humankind’s most poorly treated disease areas.

Founded on the work of Professor Moin Saleem, Professor of Paediatric Renal Medicine at the University of Bristol, Purespring is the first company to successfully treat kidney disease by targeting the podocyte, a specialised cell that is implicated in the majority of renal disease. Purespring’s platform approach enables streamlined gene therapy development for both acquired and genetic renal diseases, offering the potential to halt, reverse and even cure both rare and common kidney diseases.

The Company currently has a pipeline of programmes in development including the lead asset for treatment of IgA Nephropathy (IgAN) and other complement mediated kidney disease. The Company also has programmes for disease caused by mutations in the gene NPHS2, as well as other monogenic glomerular kidney diseases.

Based in London, the Purespring team combines world-leading expertise in podocyte biology and kidney disease with a wealth of experience in gene therapies, anchored in a culture of diversity, creativity and delivery.

Purespring is backed by leading biotech investors, including Syncona Limited, Sofinnova Partners, Gilde Healthcare, Forbion, and the British Business Bank and has raised £115m ($149m) to date.

For more information please visit: purespringtx.com and follow us on LinkedIn.