In a surprising turn of events, Omeros has halted its phase 3 trial of narsoplimab in kidney disease patients, as an interim analysis uncovered unfavorable prospects, further complicating its ongoing journey to bring this candidate to market.
The Seattle-based biopharmaceutical company sought approval for the anti-MASP2 antibody as a remedy for a complication arising from hematopoietic stem cell transplant back in 2020. Unfortunately, the FDA rejected this request, setting in motion a formal challenge by Omeros to this decision. This challenge ultimately led to a glimmer of hope in identifying an alternative path forward for the candidate. Simultaneously, Omeros was actively engaged in generating phase 3 data for narsoplimab in the context of immunoglobulin A (IgA) nephropathy.
Regrettably, the journey took an unexpected turn as the IgA nephropathy project came to an end this Monday. A preliminary review disclosed that narsoplimab demonstrated no statistically significant advantage over a placebo in reducing proteinuria, a key marker of kidney damage characterized by high levels of protein in urine. In an earlier phase 2 clinical trial, Omeros had linked its drug candidate to an impressive 64% reduction in proteinuria, positioning it favorably against competitors like Calliditas Therapeutics’ Tarpeyo and Novartis’ iptacopan. However, it’s worth noting that the phase 2 study lacked a control group. When subjected to a placebo comparison in phase 3, narsoplimab’s efficacy faded.
Also Read: FDA Awards Priority Review For Full Approval Of Tarpeyo In Treating IgA Nephropathy
According to Omeros, the reduction in urine protein excretion in the placebo group was notably higher than that observed in trials of other agents for IgA nephropathy. While some biotech firms might consider further development based on a high placebo response, Omeros has chosen to decisively exit the IgA nephropathy arena, opting to terminate the study and abandoning its pursuit of approval in this specific indication.
This strategic shift not only eliminates Omeros as a potential rival to Calliditas and Travere Therapeutics, the current players in the market, but also provides Omeros with the freedom to redirect its resources and investments into alternative projects. As of June, Omeros reported having $341.3 million in funds, a financial cushion that it anticipates will support its operations through 2025.
The news of this development had a notable impact on Omeros’ stock, which experienced a 47% decline in premarket trading on Monday, dropping from a Friday closing price of $2.27 to $1.20.
