Nephrologists Point to Profound Unmet Need for New Agents to Treat Glomerular Diseases Such as IgA Nephropathy, Focal Segmental Glomerulosclerosis (FSGS), and Lupus Nephritis

EXTON, Pa., Aug. 31, 2020 /PRNewswire/ -- Glomerular diseases pose some of the greatest challenges to nephrologists: they are progressive and potentially debilitating diseases, often have unknown causes, and there are few reliable and effective treatment options. To better understand the potential market opportunity for the multitude of assets in the pipeline, Spherix conducted several primary research studies over the summer of 2020 as part of its comprehensive, future looking Market Dynamix™ suite. Research included quantitative surveys with 100 nephrologists each, as well as in-depth discussions with leading key opinion leaders in glomerular diseases and nephrologists working "in the trenches." Research on lupus nephritis also included 100 rheumatologists to provide an all-inclusive picture.

Nephrologists consistently rank focal segmental glomerulosclerosis (FSGS), IgA nephropathy, and lupus nephritis as renal diseases having some of the greatest unmet needs and the most difficult patients to manage. This has created a significant demand for better treatment options, and the pharmaceutical market is rising to fill the void. In fact, nephrologists estimate that 91% of their FSGS patients, 81% of their IgA nephropathy patients, and 77% of their lupus nephritis patients are not being "optimally" managed at this point.

Primary FSGS presents a greater treatment challenge than secondary FSGS, which can often resolve when nephrologists treat the underlying cause, such as obesity or infection. When treating primary FSGS patients, nephrologists frequently mention the lack of clear guidelines and effective treatment options once a patient has tried steroids. As one participating nephrologist noted: "FSGS patients are probably the most challenging to treat… you have prednisone, and if that does not work, you have a whole bunch of other options – but nothing is really well-studied…"

Highlighting the critical need in FSGS, nephrologists predict that roughly one-third of their patients have had multiple relapses despite treatment. Looking towards the future, nephrologists seek a new product for FSGS that will improve the duration of remission and slow overall CKD progression. Across the pipeline, sparsentan (Retrophin), bardoxolone methyl (Reata), CX-100 (Complexa), and bleselumab (Astellas/Kyowa Kirin) among others, offer the promise of a new approach to treatment.

Nephrologists also express frustration when managing IgA nephropathy patients: some patients are well managed on ACE inhibitors and ARBs, while others need steroids yet continue to decline. It is challenging to identify which patient will advance or not, and places pressure on nephrologists to use steroids when they may not be needed. A noted collaborating physician reinforced this complexity: "[After we] use ACE and ARBs and fish oil and salt reduction first line... I do give steroids. But it is so frustrating because steroids have a lot of side effects that cannot be tolerated… [and] if it comes back after that, I am just really not sure what to do for these patients."

When evaluating new potential treatment options, nephrologists seek new options to help treat IgA nephropathy by slowing CKD progression and significantly reducing proteinuria; ideally they would most like a drug that can address the underlying cause of the disease. Surveyed nephrologists rate Reata's bardoxolone methyl, Retrophin's sparsentan, EMD Serono's atacicept, and Calliditas' Nefecon as their most desired IgA nephropathy pipeline agents.

In lupus nephritis, both rheumatologists and nephrologists see a high unmet need for new therapies; however, those in the trenches are largely unfamiliar with pipeline agents. At this point, hydroxychloroquine, mycophenylate mofetil (MMF), and steroids are the mainstays of maintenance therapy – leaving an opportunity for one of the newer agents to move in and grab significant share if it has good clinical data, strong efficacy in reducing flare frequency and severity, and is considered a "safe" treatment.

Further identifying the unmet need, another participating nephrologist mentioned: "We need agents that have less side effects. Unfortunately, we deal with a patient population that tends to be younger and need better options so the treatment effects are worse that the actual disease process."

Biologic agents and novel calcineurin inhibitors peak nephrologists' and rheumatologists' interest in potential new options to treat lupus nephritis – most specifically, a human monoclonal antibody that binds to subunit 1 of the Type 1 interferon receptors like anifrolumab(AstraZeneca). Benlysta (GlaxoSmithKline), voclosporin (Aurinia), and obinituzumab (Genentech) also rank highly as anticipated treatment options among both nephrologists and rheumatologists.

About Market Dynamix™
Market Dynamix™ is an independent, subscription-based service that explores future dynamics of evolving healthcare markets within specific indications to help your company make well-informed, strategic decisions. The Spherix research method pairs together both qualitative analyses, fueled by interviews with leading international opinion leaders, and quantitative analysis (n=~100), leveraging a proprietary network of specialists "in the trenches."

Each of the indications covered in Market Dynamix™ are expanded upon in recently published reports included in parallel services offered by Spherix – including physician reactions to detailed product profiles and estimates on patient candidacy for each upcoming product. Please reach out for more information or details.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

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Kristen Henn, Business Development Manager
Email: [email protected]
www.spherixglobalinsights.com

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