Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, 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.