S1P

AbbVie’s Skyrizi has demonstrated significantly higher rates of steroid-free clinical and endoscopic remission versus rival Johnson & Johnson’s Stelara in a Phase III trial, helping set the Crohn’s disease drug apart in an increasingly competitive market. Stelara won an FDA approval for Crohn’s disease in 2016, while Skyrizi was approved three years later in 2019. But the competition is heating up with Stelara biosimilars set to enter the market in 2025, government price negotiations in 2026, and a new rival emerging in the form of Pfizer’s oral S1P inhibitor Velsipity for ulcerative colitis. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

AbbVie's Rinvoq is primed for breakout switching opportunities in the EU5 UC market with its approval by the EMA EXTON, Pa., Aug. 16, 2022 /PRNewswire/ -- According to the latest report published as part of Spherix's RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) service, EU gastroenterologists (n=285) have accelerated their switching of ulcerative colitis (UC) and Crohn's disease (CD) patients from anti-TNF therapies to treatments that include new pathways such as IL12/IL23 inhibition, α4β7 integrin binding, JAK inhibition, and S1P modulation.The Spherix study includes 1,280 unique IBD patient records from the EU5 (France, Germany, Italy, Spain, and the UK) that encapsulate patient-level data. All patients were recently switched from one advanced therapy to another, and the study examines several aspects of the process of switching, such as the criteria for assessing a potential switch patient, the clinical attribute drivers in the decision to switch, and the consideration set for switched therapies. The report also identifies a significant level of opportunity that still exists for new pathways and agents in IBD. Similar to previous years, more than one-quarter of UC and CD patients are switched to another advanced therapy every year due to efficacy of a therapy waning or patients being unable to get to full clinical remission. More specifically, 27% of UC patients and 30% of CD patients who have recently switched did so because of secondary efficacy failure. The biosimilar therapies (infliximab and adalimumab) are the two treatment options most likely to trigger an efficacy-based switch. In UC, half of the patients who switched due to secondary efficacy failure were previously on a biosimilar; in CD, that estimate rises to 55%. In fact, when combining biosimilars and brands, TNF therapy represents the switch-from agent for a majority of all UC and CD patients. While EU5 gastroenterologists may be switching to another TNF therapy in some cases, alternative mechanism of action therapies (AMOAs) represent more than half of all the "switched to" therapies in UC and CD treatment areas. While Galapagos/Gilead's Jyseleca and BMS' Zeposia are recently AMOA switch options since their approval late last year, Janssen's Stelara is still the most commonly switched to AMOA therapy, capturing nearly one-fifth of all UC switches and close to one-third of all CD switches. Along with a deep profile of each patient record in terms of time since diagnosis, comorbidities, lab results, and treatment history – the report profiles each available UC and CD brand, along with the infliximab biosimilars and adalimumab biosimilars as a separate class (across several different metrics), including: Time on the previous agent before switching Primary and secondary reasons for switching with follow-up probes if efficacy, cost, safety or tolerability is the reason for the switch Primary and secondary reasons for new choice/switched to agent with follow-up probes if efficacy, MOA, patient request, is the reason for the selection What other agents were also considered at the switch and analysis of why the selection was/was not made The audit also includes a future perspective as it asks about the potential switch opportunities for several UC and CD pipeline therapies if they were approved and available. Most notably, this analysis revealed a significant potential for future switching to AbbVie's Rinvoq (upadacitinib) in UC, given its approval by the EMA. About RealWorld Dynamix™ RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,200 patients. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. 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. For more information contact: Paul Zimmerman, Vice President, Insights Email: [email protected] SOURCE Spherix Global Insights

At the virtual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting this week, multiple companies are presenting data for ongoing studies of therapies for multiple sclerosis, a disabling disease of the central nervous system that affects more than one million people in the United States. BioSpace takes a look at some of the data. Genentech Genentech released new long-term data from the Phase III OPERA I and OPERA II studies that demonstrated the safety and efficacy of Ocrevus as a treatment for MS. The data showed that the use of Ocrevus led to a 35% reduction in risk of needing a walking aid in relapsing multiple sclerosis (RMS) patients after 7.5 years of use. This was compared to those who switched from treatment with interferon beta-1a to Ocrevus after a 96-week double-blind period. Data also showed that switching from interferon beta-1a to Ocrevus at the start of the open-label extension (OLE) period was linked with a rapid and robust reduction in annualized relapse rate, which was maintained through the 5.5-year OLE period. Additionally, data from the Phase III ORATORIO OLE study showed that early use of Ocrevus in patients with primary progressive is favorable. Eight-year data showed that treating Ocrevus demonstrated a 29% reduction of 48-week confirmed disability progression in MS after eight years. That’s in comparison to trial patients who switched to Ocrevus from placebo after the double-blind period of at least 120 weeks. Many people with PPMS eventually transition into a wheelchair; therefore, maintaining the ability to use their hands and arms, which is essential for these patients. The company also released data from shorter infusion studies of Ocrevus in minority patients that showed reactions were similar in Black, African-American, Hispanic, and Latino patients. Genentech stated that these patient populations “may experience greater disease severity and faster progression, yet are vastly underrepresented in most clinical trials.” The company noted that a shorter infusion time might help reduce the burden on these patient populations and increase their access to treatment. Biogen Boston-based Biogen also presented data at ECTRIMS showcasing the benefit of its interferon treatment for MS patients who have been vaccinated against COVID-19. Biogen showed that 100% of MS patients treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination. Additionally, the data from the analysis revealed that 40% of these patients who were treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine. Approximately 92% of patients analyzed in the study received an mRNA vaccine. Immune response was measured using immunoglobulin G (IgG) assays. Data for the study was gained from blood samples provided by the MS PATHS network, with preliminary results suggesting that anti-CD20 and sphingosine 1-phosphate (S1P) therapies may reduce the antibody response to COVID-19 vaccination. Other classes of MS drugs were also assessed in the study, including the company’s own therapies, which showed the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy. Biogen Chief Medical Officer Maha Radhakrishnan acknowledged the analysis as it provides essential information for MS patients during the global pandemic. She also noted that the company wanted MS patients and caregivers to have the information at hand in order to understand levels of protection against the virus. “Leveraging the unique MS PATHS network, we were able to quickly generate data on the impact of the different MS DMTs on COVID-19 vaccine antibody responses. This is part of a comprehensive plan to understand B and T cell activation in the context of people with MS on DMTs being vaccinated for COVID-19 and will add to efforts by researchers to gather these important data,” Radhakrishnan said in a statement. Sanofi Sanofi also showcased data for its experimental MS drug, tolebrutinib, an oral brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor. Data from a Phase IIb long-term extension study in RMS showed that following 48 weeks of treatment, tolebrutinib reduced multiple sclerosis disease activity as measured by MRI. Trial results showed favorable safety and efficacy for tolebrutinib. At the one-year mark, nearly all patients remained enrolled in the study. Patients who were treated with 60mg of tolebrutinib experienced low annualized relapse rates over the 48 week period. The majority of the patients, 89.5%, were relapse free during this time period. Tolebrutinib is being assessed in multiple Phase III clinical trials for the relapsing forms of MS, as well as non-relapsing secondary progressive MS and primary progressive MS. Erik Wallstrom, therapeutic area head of Sanofi’s neurology department, noted that the studies are critical to understanding the ability of a brain-penetrant therapy to slow disability accumulation in MS patients. Tolebrutinib has the potential to “bring new hope to people suffering from difficult-to-treat MS,” he said in a statement.