Atacicept

Bengaluru: Otsuka 's experimental drug for a type of kidney disease showed over 50 per cent reduction in protein in patients' urine in a late-stage trial, the Japan-based company said on Friday. Patients treated with the therapy, sibeprenlimab , achieved a 51.2% reduction in proteinuria at nine months of treatment when compared to placebo. The company is seeking approval for the therapy, a monoclonal antibody, to treat Immunoglobulin A Nephropathy (IgAN), also known as Berger's disease , which causes abnormal protein buildup in the kidneys and could eventually lead to the organ's failure. It was the largest IgAN trial to date, which consisted of about 510 adult patients the company said. The U.S. health regulator is set to decide on the marketing application of the therapy by November 28. Shares of rival Vera Therapeutics fell over 31% in premarket trading. Vera's experimental drug, atacicept, reduced protein levels in patients' urine by 46%, compared with a 7% reduction with a placebo, meeting the main goal of the 428-patient late-stage study, the company said on Monday. (Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru)

Otsuka has shared the specifics of a late-stage win for a rare kidney disease treatment that’s on track to become its first wholly-owned product to be sold in the US. The biotech’s monoclonal antibody, called sibeprenlimab, achieved a 51.2% reduction in levels of protein in urine at nine months versus placebo in the Phase 3 VISIONARY trial, according to data presented Friday at the European Renal Association’s annual meeting in Vienna. The study is enrolling 510 adults with a kidney condition called immunoglobulin A nephropathy (IgAN) who are taking standard therapy. Reducing proteinuria is important because the higher the levels of protein in urine in IgAN, the more likely patients are to have progressive kidney disease and, in some cases, end-stage kidney disease, VISIONARY investigator Dana Rizk told Endpoints News in an interview. While it is difficult to compare results from separate trials, the sibeprenlimab data seem to have a slight edge over Vera Therapeutics’ IgAN candidate, atacicept, which also targets the APRIL ligand. Atacicept led to a 42% drop in proteinuria at nine months versus placebo, according to Vera’s Phase 3 data reported earlier this week. But variability in proteinuria measurements means the nine percentage-point difference between the candidates is unlikely to translate to a real difference in clinical efficacy, TD Cowen analysts wrote Friday. Even so, Vera’s share price $VERA was down around 30% at market open Friday. Both sibeprenlimab and atacicept are subcutaneous injections that patients can choose to self-administer, but Otsuka’s candidate has a convenience advantage because it is dosed once a month, as opposed to atacicept’s once-weekly regimen. In addition to APRIL, Vera’s treatment targets a family of ligands called BLyS. In animal studies, inhibiting both targets has been shown to drive the destruction of B cells in the spleen, whereas inhibiting APRIL alone had minimal effects on those cells, Otsuka chief medical officer John Kraus told Endpoints in a separate interview. Sibeprenlimab could therefore have the potential for differentiated safety, he added. The candidate is currently under FDA priority review after the Japanese drugmaker submitted its first biologics license application with the agency in March, when it first reported that the VISIONARY trial was successful at an interim analysis. The FDA is set to make a decision by Nov. 28 . If the regulatory review is positive, Otsuka would have a market head start versus Vera, which doesn’t plan to file for accelerated approval for atacicept until the fourth quarter. But the IgAN commercial landscape is already quite competitive. Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo have been on the market for a few years now. In 2024, Novartis’ factor B inhibitor Fabhalta secured an accelerated approval for IgAN, and earlier this year, the Swiss drugmaker’s ETA receptor antagonist Vanrafia also clinched a speedy approval . Vanrafia is a once-daily pill, meaning patients could prefer it over injectables like sibeprenlimab and atacicept. Sibeprenlimab was one of several programs at the heart of Otsuka’s $430 million acquisition of Visterra in 2018. Editor’s note: This article was updated throughout to add additional context and Vera’s stock move at market open.