Spherix Global Insights

 – In what has been a transformative year for ulcerative colitis (UC) treatment, the IL-23 class has solidified its role as a key therapeutic treatment option. With Johnson & Johnson’s Tremfya now joining AbbVie’s Skyrizi and Lilly’s Omvoh, gastroenterologists have three powerful IL-23 options at their disposal.

The IL-23 class has rapidly gained significant momentum, capturing one-tenth of the advanced systemic UC market over the course of 2024, according to Spherix’s 

 service. This rapid growth is fueled by the strong reputation of IL-23 inhibitors, reinforced by Skyrizi’s success and Tremfya’s recent approval, positioning IL-23s as the leading mechanism of action for UC in the eyes of physicians (n=106)—a trend Spherix has closely monitored over the past two years.

The study also shows that Tremfya has made a strong debut, with a large majority of gastroenterologists aware of its September 11

 approval in UC. Over one-fifth of gastroenterologists have already prescribed Tremfya, surpassing early trial rates for Lilly’s Omvoh at a similar post-launch timeframe, but falling short of what was tracked for Skyrizi. In the coming six months, gastroenterologists project Tremfya’s growth to outpace Omvoh, positioning it as the likely second most-prescribed IL-23 therapy.

Differentiation among the IL-23 therapies will be essential as Tremfya and Omvoh vie for position against Skyrizi, the current frontrunner. Already, a majority of gastroenterologists view the IL-23 agents as clinically distinct, with Skyrizi emerging as the preferred option. AbbVie, Johnson & Johnson and Lilly are making efforts to differentiate their agents. Omvoh, for instance, stands out for its impact on bowel urgency—a symptom highlighted by Lilly’s CONFIDE study. Tremfya is noted for its dual mechanism that binds not only to IL-23 but also to CD64, a receptor on IL-23-producing cells. Skyrizi distinguishes itself with an on-body injector device and its earlier approval for Crohn’s disease, which gave physicians valuable experience with the drug before its approval for UC.

As 2024 closes, Spherix anticipates an equally dynamic 2025 as IL-23s continue to shape the competitive landscape in UC. Spherix’s gastroenterology team will continue to monitor UC market developments through its 

 service in addition to tracking each specific launch closely in its 

 is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

 is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

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https://clientportal.spherixglobalinsights.com

Jim Hickey, Gastroenterology Franchise Head

: 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.

Articles

The IL-23 class has emerged as a pivotal treatment option for ulcerative colitis (UC), with Johnson & Johnson's Tremfya joining AbbVie's Skyrizi and Lilly's Omvoh. This class has captured a significant market share, driven by the success of Skyrizi and Tremfya's recent approval. Differentiation among these therapies is crucial, with Skyrizi leading due to its unique features. Spherix Global Insights anticipates continued growth and competition in the UC market, providing strategic guidance through its RealTime Dynamix™ and Launch Dynamix™ services to monitor these developments.

Future intensified intra-class competition among Omvoh, Skyrizi and Tremfya is expected as each brand attempts differentiation.

Tremfya’s Promising Debut Boosts Momentum for IL-23 Class in Ulcerative Colitis Treatment, According to Spherix Global Insights

EXTON, PA., November 1, 2024 — 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 

 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 

 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 

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.

 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.

To learn more about Spherix Global Insights, visit 

For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here: 

Focal segmental glomerulosclerosis (FSGS) is a prevalent glomerular disease with significant unmet therapeutic needs. Current management challenges include the lack of approved treatments and the long-term impacts of steroid use. Nephrologists report that nearly half of FSGS patients are not optimally managed, with many expected to require dialysis within a decade. The use of SGLT2 inhibitors and genetic testing for the APOL1 gene are notable advancements. New treatments in development, such as sparsentan, inaxaplin, and DMX-200, show promise in addressing these challenges and improving patient outcomes.

US nephrologists estimate half of all FSGS patients are not optimally managed, according to Spherix Global Insights.

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

 Complement 3 glomerulopathy (C3G) is a rare, progressive kidney disease characterized by inflammation and kidney damage. Patients with C3G often experience high blood pressure, protein or blood in the urine, swelling, fatigue, and recurrent infections. While existing treatments such as steroids and immunosuppressants offer short-term relief, they come with risks and side effects. As patients have limited long-term solutions, physicians identify an urgent need for innovative therapies. 

Spherix has been tracking the C3G market for over four years in both the U.S. and Europe. The studies have provided meaningful insights into physician perceptions of unmet needs and expectations for pipeline agents. Further, they have analyzed more than 400 C3G patient charts across regions to reveal the true evolution of treatment patterns and patient types.

Market Dynamix™: Complement 3 Glomerulopathy (US)

 study that collected perspectives from 101 U.S. nephrologists confirm nephrologists’ strong interest in being able to leverage new therapies for C3G, emphasizing the importance of clinical data that demonstrate slowed eGFR decline, proteinuria reduction, and other critical efficacy markers. They also highlight the value of treatments targeting the complement system pathways to directly address the disease’s underlying mechanisms. 

Patient Chart Dynamix™: Complement 3 Glomerulopathy (US)

 study, which analyzed 157 C3G patient records from 94 nephrologists, reveal that physicians would likely treat up to half of their C3G patients with these new agents if approved. At this point, nephrologists project that the majority of audited C3G patients are likely to require dialysis within the next ten years – a rate that surpasses many other renal diseases. This projection underscores their desire and the critical need for treatments that can fill gaps in care and delay disease progression. 

Late-stage candidates from Novartis (Fabhalta) and Apellis (Empaveli) show promise in C3G and are nearing potential FDA approval. Both therapies, already approved in the U.S. for paroxysmal nocturnal hemoglobinuria (PNH), and IgA nephropathy (IgAN) in the case of Fabhalta, are advancing through Phase III trials for C3G and are expected to have regulatory submissions in the coming months. However, Spherix data indicates that treatment preferences are likely to be influenced by the route of administration, with Fabhalta taken orally twice daily and Empaveli administered subcutaneously twice weekly.

At ASN Kidney Week in October, Novartis presented one-year data from its Phase III APPEAR-C3G trial of Fabhalta (iptacopan), an oral complement inhibitor, on C3G patients. The data demonstrated a significant and sustained reduction in proteinuria within 14 days of treatment, lasting up to 12 months. The drug met its primary endpoint at six months, and Novartis has already submitted applications for approval beyond the U.S. in the EU, China, and Japan.

Apellis, in collaboration with European partner Sobi, also presented Phase III VALIANT trial data for Empaveli (pegcetacoplan) at the conference, showing a 68.1% reduction in proteinuria versus placebo, with 71.4% of treated patients achieving zero C3c staining intensity, signaling C3c deposit clearance. The VALIANT trial includes patients with C3G and IC-MPGN, demonstrating early efficacy by week four.

Following ASN, Spherix fielded a follow-up study to U.S. nephrologists who attended the conference to understand their engagement with the meeting content and industry events, sessions that were most popular, reactions to high-impact clinical trials and poster presentations, including the latest updates in C3G, and more. Results will be available this week.

As the C3G treatment landscape evolves, with increasing investment and promising therapies on the horizon, Spherix will continue to provide in-depth insights into market developments through its 

 tracking series as products gain approval. 

 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.

 is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

: 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 endorsement of the companies or brands mentioned in this press release.

Complement 3 glomerulopathy (C3G) is a rare kidney disease with limited long-term treatment options, prompting a need for innovative therapies. Spherix Global Insights has been analyzing the C3G market, revealing nephrologists' interest in new treatments targeting complement system pathways. Promising late-stage candidates, Novartis' Fabhalta and Apellis' Empaveli, are nearing FDA approval. Recent trials show significant proteinuria reduction, highlighting their potential. Spherix continues to provide insights into market developments, aiding in understanding treatment patterns and the impact of emerging therapies on the C3G landscape.

Findings from Spherix Global Insights show that practitioners consider nearly half of their C3G patients to be potential candidates for Fabhalta or Empaveli, if approved. 