Purespring Therapeutics receives UK CTA approval for Phase I/II clinical trial of PS-002 in patients with primary IgA nephropathy (IgAN)

• First patient in Phase I/II clinical trial expected to be enrolled in Q4 2025
• UK Clinical Trial Application (CTA) approval shortly follows U.S. IND clearance and granting of European Medicine Agency (EMA) orphan drug designation, enabling readiness for initiation across sites in both the U.S. and Europe
• PS-002, Purespring’s lead precision nephrology programme, targets the complement pathway known to be a driver of IgA nephropathy and is supported by a wealth of preclinical data

London – 5 August 2025--Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today 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).

“The CTA approval for our Phase I/II clinical trial of PS-002 represents another key milestone as we complete our transition to a clinical-stage precision nephrology company,” said Haseeb Ahmad, Purespring’s Chief Executive Officer. “Building on the recent FDA IND clearance and EMA orphan drug designation, this further validates the potential of our podocyte-targeting approach to go beyond symptom management and directly target kidney disease at its source. Looking ahead, we are committed to working closely with regulators and sites across the U.S. and Europe with the view to expand the therapeutic options available for people living with IgAN.”

PS-002 was 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 IgA nephropathy (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.

The Phase I/II clinical trial, which is expected to enroll its first patient in Q4 2025, will evaluate local administration of PS-002 to treat IgAN. In the Phase 1 part of the Phase I/II study, the main read-outs will be safety parameters, which, together with efficacy biomarkers, will be leveraged to select a dose for the Phase 2 part of the study. This second phase will be used to further define the safety profile and provide early markers of efficacy. Enabled by this latest regulatory approval and the recent U.S. IND clearance, as announced in July 2025, the Phase I/II study will recruit patients across the U.S. and Europe.

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