The US Food and Drug Administration (FDA) has approved Purespring Therapeutics’ investigational new drug (IND) application for PS-002, allowing the company to begin a Phase I/II trial for the treatment of primary IgA nephropathy (IgAN), a rare and chronic autoimmune kidney condition.
The upcoming clinical trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.
It will assess the local administration of the therapy, which is tailored to offer long-term benefits after a single treatment.
The Phase I segment of the trial will concentrate on safety parameters. The safety outcomes alongside efficacy biomarkers will be utilised to choose a dose for the trial’s Phase II component, which will explore both safety and early efficacy markers.
PS-002 is the company’s lead programme, designed to address the root cause of several kidney diseases by modulating complement activation within the kidney through targeting of podocytes.
The company noted that the programme’s initial focus is on treating IgAN, which predominantly impacts the young adult population.
The disease is characterised by the accumulation of abnormal IgA protein in the filters of the kidneys, called glomeruli, leading to inflammation and potential kidney failure. Despite existing treatments, a considerable number of individuals progress to kidney failure.
Purespring Therapeutics CEO Haseeb Ahmad said: “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.
“By doing so, we aim to move beyond systemic therapies to specifically kidney-targeted therapeutics and provide durable disease-modifying treatments for patients.”
Earlier this year, the European Medicines Agency (EMA) granted an orphan drug designation to the therapy for IgAN treatment.
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