Omeros Coroporation’s narsoplimab has failed to produce positive results in an interim analysis of a Phase III trial investigating its use in immunoglobulin A (IgA) nephropathy.
The ARTEMIS-IGAN trial (NCT03608033) evaluated the safety and efficacy of the candidate, also known as called OMS721,in patients with the autoimmune kidney disease.
The randomised, double-blind trial’s primary endpoint was the reduction in proteinuria assessed by 24-hour urine protein excretion (UPE) at 36 weeks compared to placebo. According to a company press release, narsoplimab, which is a lectin pathway inhibitor, did not demonstrate a statistically significant improvement in proteinuria reduction.
Omeros stated the reduction observed in the placebo group was far higher than data reported in other trials of IgA nephropathy. In a webcast call on 16 October, Omeros’s management team said the placebo results were “frankly surprising” and that it will continue to further analyse the data to understand the outsized effect.
Although well tolerated and with a consistent safety profile, the negative efficacy results mean Omeros will not submit an approval application for this indication and the trial has been shelved. In the call, Omeros was keen to highlight that the trial results will not affect other indications for narsoplimab or the company’s other lectin pathway inhibitors in the pipeline.
In the same announcement, Omeros CEO Gregory Demopulos said that the company intends to resubmit a biologics licence application for narsoplimab to the US Food and Drug Administration (FDA) for haematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.
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By GlobalDataFunds from the discontinued trial will now be diverted to an ongoing Phase II trial and upcoming Phase III trial for the company’s alternative pathway inhibitor OMS906 in the treatment of paroxysmal nocturnal haemoglobinuria.
Around 60,000 individuals in the US are estimated to have IgA nephropathy, also known as Berger disease. The disease damages glomeruli, resulting in impaired blood filtration. In June 2023, Vera Therapeutics initiated a Phase III trial investigating atacicept 150mg for the treatment of IgA nephropathy.
