Pending regulatory submission, Fabhalta (iptacopan) could become the first approved therapy for C3G, addressing a significant unmet need in nephrology, according to Spherix Global Insights.
EXTON, PA., June 13, 2024 – Complement 3 glomerulopathy (C3G) is a rare kidney disease that presents significant challenges for both patients and nephrologists. Currently, there are no therapies specifically approved to treat this disease. Without effective treatment, the majority of C3G patients ultimately progress to kidney failure, requiring dialysis or a kidney transplant to survive. Healthcare providers may prescribe various treatments to manage symptoms and slow disease progression; however, the absence of targeted therapies leaves a critical gap in treatment options for C3G patients.
Data from Spherix’s second annual Patient Chart Dynamix™: C3G (EU5) study captured the perspectives of 148 nephrologists (located in the United Kingdom, Germany, Italy, Spain, and France) regarding the urgent need for effective treatments, as well as how their treatment approach for C3G patients has evolved. Physicians emphasized the importance of early intervention for successful patient outcomes, yet many find C3G more challenging to diagnose compared to other glomerular diseases.
The study, which included an analysis of 148 C3G patient records, revealed that current treatment regimens for C3G patients are complex and burdensome, with many patients having to endure a heavy medication burden. The audited patient charts show that treatment often involves a combination of antihypertensive agents and an SGLT2 inhibitor. Notably, the use of SGLT2 inhibitors has increased year-over-year in C3G patients, while the agents are also being applied as an earlier line of therapy. Nephrologists also prescribe systemic corticosteroids and immunosuppressive agents for these patients, often based on their rate of eGFR decline and level of proteinuria. Importantly, factors that drive treatment changes in C3G patients have shifted year-over-year, indicating that nephrologists are adjusting the way that they are monitoring and approaching treatment for these patients, with eGFR and proteinuria both playing a key role in their prescribing decisions.
Despite these shifts in management, less than half of EU5 nephrologists reported they feel confident in their ability to get their C3G patients to target proteinuria levels with the existing available treatments, and that the majority of these patients are difficult to manage, highlighting the opportunity for new agents to provide more efficacious treatment options. Furthermore, physicians reported that they anticipate more than three-quarters of the audited C3G patients will eventually progress to end-stage renal disease (ESRD) and require dialysis, with most expected to reach this stage within the next decade.
Fortunately, promising new treatments for C3G are in development, with key data recently presented at the 61st European Renal Association (ERA) Congress. Of note, Novartis presented results from the Phase III APPEAR-C3G study of Fabhalta (iptacopan), showing a significant 35.1% reduction in proteinuria at six months for patients receiving Fabhalta plus supportive care, compared to placebo plus supportive care. These results support upcoming regulatory submissions to the FDA and EMA in the second half of 2024.
In late 2023, Spherix published its inaugural C3G patient chart audit study in the US. Nephrologists from both the US and EU5 regions identify a substantial proportion of their C3G patients as potential candidates for Novartis’ Fabhalta (iptacopan), as well as Apellis’ Empaveli (pegcetacoplan). Additional pipeline assets from Q32 Bio, Omeros, and other companies offer hope for both nephrologists and patients to be able to better manage this debilitating condition.
Spherix will continue to closely monitor the evolving C3G market through its Patient Chart Dynamix™ and Market Dynamix™ studies.
Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
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Spherix Global Insights Contact
Meghan Weiss, Nephrology Franchise Head,
meghan.weiss@spherixglobalinsights.com
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