Purespring Therapeutics has received approval for its UK clinical trial application (CTA) for a Phase I/II trial of its lead programme, PS-002, to treat IgA nephropathy (IgAN).
Approval from the UK Medicines and Healthcare products Regulatory Agency, the NHS Health Research Authority, and the Research Ethics Committee helps to prepare for the trial, with first subject enrolment anticipated to commence in the fourth quarter (Q4) of this year.
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The upcoming trial will assess the local administration of the therapy in subjects with IgAN.
The initial phase of the trial will focus on safety parameters and efficacy biomarkers to determine an appropriate dose for the subsequent phase.
Phase II will continue to evaluate the safety profile and seek early efficacy indicators.
Purespring Therapeutics CEO Haseeb Ahmad said: “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.
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By GlobalData“Building on the recent [US] Food and Drug Administration (FDA) IND clearance and European Medicines Agency (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.”
According to the company, the therapy is designed to address the root cause of many kidney conditions by modulating complement activation directly within the kidney, with a focus on targeting podocytes.
IgAN is an uncommon and chronic autoimmune disease of the kidneys that predominantly impacts young adults.
The disease process in IgAN involves aberrant IgA proteins accumulating in the kidney’s glomeruli, triggering complement activation, inflammation, damage, and scarring.
Purespring’s pipeline includes programmes aimed at treating IgAN and other complement-mediated kidney conditions, as well as conditions originating from mutations in the NPHS2 gene, and other monogenic glomerular kidney diseases.
With financial support from biotech investors such as Sofinnova Partners, Syncona, Gilde Healthcare, Forbion, and the British Business Bank, Purespring has so far raised a total of $149m.
