Critical Gaps in FSGS Treatment Highlight Need for New Therapies, with Pipeline Assets from Travere, Vertex, and Dimerix Poised to Address Unmet Needs

EXTON, PA, Nov. 01, 2024 (GLOBE NEWSWIRE) — Focal segmental glomerulosclerosis (FSGS), one of the most common glomerular diseases seen by nephrologists, ranks among the top three rare kidney diseases with critical unmet therapeutic needs, according to Spherix Global Insights 2024 Market Dynamix^TM: FSGS (US) study. With no treatments currently approved specifically for FSGS, patients and physicians alike face the challenge of managing a progressive disease and the long-term impacts of steroid use.

FSGS presents significant management challenges, with nephrologists (n=102) estimating that, on average, nearly half of their patients are not optimally managed with existing therapies. Spherix’s latest analysis from its Patient Chart Dynamix^TM: FSGS (US) study of over 400 chronic kidney disease (CKD) non-dialysis patients with primary FSGS reveals that nephrologists anticipate more than half of these patients will require dialysis within the next decade, with only a small fraction likely to avoid it altogether. This underscores an urgent need for effective new treatments and highlights a substantial opportunity for innovation in the market.

A notable advancement in FSGS treatment has been the rising use of SGLT2 inhibitors, with nephrologists reporting that utilization has doubled in the past two years. These agents are increasingly adopted as standard care in CKD management, particularly valued for their ability to slow eGFR decline – a primary treatment goal highlighted by physicians when managing FSGS patients.

Genetic testing among FSGS patients has also expanded considerably, with physicians increasingly screening for the APOL1 gene due to its strong link to heightened FSGS risk. As a result, their treatment strategies have become more aggressive for APOL1-positive patients, underscoring the growing importance of personalized medicine in FSGS management.

Several companies are advancing new treatments for FSGS, with the greatest potential for success seen in assets that can slow eGFR decline, reduce proteinuria, and sustain disease remission. Leading the FSGS pipeline are sparsentan (Travere), marketed as FILSPARI for IgA nephropathy, and inaxaplin (Vertex), under development for APOL1-mediated kidney disease (AMKD), and DMX-200 (Dimerix) – all currently in Phase 3 trials. Notably, both inaxaplin and DMX-200 have recently garnered increased interest from nephrologists as potential treatment options for FSGS patients.

As nephrologists and researchers strive to improve FSGS patient care, the need for innovative therapies remains a top priority. Spherix will continue to monitor developments in the FSGS landscape through its Market Dynamix™ and Patient Chart Dynamix™ services.

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.

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.

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NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorse.FSGS

Meghan Weiss, Nephrology Franchise Head
Spherix Global Insights
484-879-4284
Meghan.Weiss@spherixglobalinsights.com