Sobi to share new clinical data and research at EULAR 2025
STOCKHOLM, May 28, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) will present new clinical data and research outcomes at the annual European Congress of Rheumatology (EULAR 2025) in Barcelona from the 11-14 June 2025. Research will include clinical trial outcomes on the efficacy and safety of Gamifant in the treatment of macrophage activating syndrome, updates on trial details of Vonjo investigating the potential treatment of VEXAS, and an analysis on the management of uncontrolled gout.
Sobi will host a symposium on the dermatologic, rheumatologic, and hematologic features of VEXAS syndrome during the congress. The symposium will be chaired by Dr Sophie Georgin-Lavialle MD, PhD from the French National Reference Centre for auto-inflammatory diseases and inflammatory amyloidosis. The symposium will be followed by a panel discussion and Q&A.
"We are delighted that our continued advancements in treating rare disease, including those suffering with the most debilitating rheumatology conditions will be presented at this year's EULAR conference. Sobi's presentations will provide insights and treatment options for those working with patients with rheumatological conditions, providing them with the most up-to-date clinical data and approaches," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi.
"With several poster and oral presentations and a longer form symposium, we are proud to be able to show how research and collaboration can advance clinical practice – and we look forward to meeting and connecting with colleagues in Barcelona," Lydia Abad-Franch concluded.
Key data to be presented at EULAR 2025
Gamifant (emapalumab)
Efficacy and Safety of emapalumab in Patients with Macrophage Activation Syndrome in Still's disease: Results from a Pooled Analysis of Two Prospective Trials
Speaker: Professor Fabrizio De Benedetti (principal investigator of the study)
Oral presentation
Session title: Clinical Abstract Session: Proceedings in Juvenile Idiopathic Arthritis
Session date: Thursday 12 June
Session time: 10:30 - 12:00 CEST
Presentation time: 10:48 - 10:57 CEST
Location: Room 6.1
Exposure-safety analysis from two clinical trials of emapalumab in patients with macrophage activation syndrome in Still's disease
Speaker: Professor Fabrizio De Benedetti (principal investigator of the study)
Poster presentation
Session title: Poster View VI
Session date: Friday 13 June
Session time: 12:00 – 13:30 CEST
Location: Poster Hall
NASP (formerly SEL-212)
Variations in uncontrolled gout between Rheumatologists and Nephrologists
Poster presentation
Session title: Poster View VIII
Session date: Friday 13 June
Session time: 10:15 - 11:45 CEST
Location: Poster Hall
Vonjo (pacritinib)
Development of a Consensus Definition of VEXAS Flare for Use in Clinical Research
Poster presentation
Session title: Poster View VII
Session date: Friday 13 June
Session time: 14 :45 - 15 :45 CEST
Location: Poster Hall
PAXIS: A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Phase 2 Study (Part 1) Followed by an Open-Label Period (Part 2) to Assess the Efficacy and Safety of Pacritinib in Patients with VEXAS Syndrome
Poster tour
Session Title: Poster Tour II/ Clinical and Basic Poster Tours: Autoinflammatory Diseases including VEXAS
Session date: Saturday 14 June
Session time: 10:15 -11:45 CEST
Presentation time: 10:29 - 10:36 CEST (4 mins + 2 mins Q&A)
Location: Poster Tour II
Development of a Disease Activity Index for the Assessment of VEXAS Syndrome (VEXAS-DAI)
Poster tour
Session title: Poster Tour II/ Clinical and Basic Poster Tours: Autoinflammatory Diseases including VEXAS
Session date: Saturday 14 June
Session time: 10:15 - 11:45 CEST
Presentation time: 10:43 - 10:50 CEST (4 mins + 2 mins Q&A)
Location: Poster Tour II
Medical Symposium
An in-depth presentation on VEXAS syndrome: the dermatologic, rheumatologic, and hematologic features of the condition. Followed by a panel discussion and Q&A
Symposium title: Putting on your VEXAS goggles: Seeing what's in plain sight
Session date: Friday 13 June
Session time: 17:30 - 18:30 CEST
Location: Fira de Barcelona, Room B4
About Gamifant® (emapalumab)
Gamifant® (emapalumab) is indicated for the treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
About Macrophage activation syndrome (MAS)
Macrophage activation syndrome (MAS) is a potentially life-threatening complication of Still's disease characterised by interferon-gamma (IFNγ)–driven systemic hyperinflammation. More than one-third of patients inadequately respond to high-dose glucocorticoids. Emapalumab, an anti-IFNγ antibody, demonstrated efficacy and safety in a phase 2 pilot study in patients with MAS in Still's disease and an inadequate response to high-dose glucocorticoids.
About NASP, formerly SEL-212
NASP is a novel investigational medicine designed to reduce serum urate (SU) levels in people with uncontrolled gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. NASP is administered every 4-weeks as a sequential, two-component, infusion therapy consisting of tolerogenic nanoencapsulated sirolimus (NAS) which mitigates the formation of anti-drug antibodies (ADAs) and a uricase, pegadricase (P), which reduces serum uric acid. ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including uncontrolled gout.
About VONJO® (pacritinib)
VONJO is a kinase inhibitor that is indicated in the US for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
About VEXAS
VEXAS syndrome is a disease that causes inflammatory and hematologic (blood) manifestations. The syndrome is caused by mutations in the UBA1 gene of blood cells and acquired later in life. The condition is not genetically inherited.
About Sobi
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.
This information was brought to you by Cision http://news.cision.com
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Sobi share New clinical Data and Research at EULAR 2025
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Once-weekly subcutaneous amycretin treatment escalated up to 60 mg appeared tolerable with a safety profile consistent with other GLP-1 and amylin receptor agonists.1,2 The number of treatment-emergent adverse events (TEAEs) increased in a dose-dependent manner, were mostly gastrointestinal, and were comparable to the rate and profile of TEAEs reported in early-phase studies of GLP-1 receptor, GLP-1 receptor/gastric inhibitory polypeptide (GIP) receptor, and amylin receptor agonists.1,2 The majority of TEAEs were mild to moderate in severity and resolved by the end of the study period.1,2 Of the participants who discontinued the trial, the majority were due to non-TEAE reasons.1,2 'As pioneers in obesity innovation, we are exploring multiple biological pathways to develop potentially transformative medicines that support the individual needs and preferences of people with obesity on their weight loss journey towards overall improved health,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 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No new safety signals appeared during the study.3 Based on the findings from the oral and subcutaneous amycretin trials, Novo Nordisk recently announced it will advance amycretin into phase 3 trials to further investigate the treatment as a potential new therapeutic option for weight management.4 About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration. Oral amycretin Phase 1 trial - The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in 144 people with overweight or obesity, with a total treatment duration of up to 12 weeks. Subcutaneous amycretin Phase 1b/2a trial - The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in 125 people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________References The Lancet: Dahl K, Toubro, S, Dey S, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: Results of a randomised, controlled, phase 1b/2a study. Dahl, K, et al. (2025). Amycretin, a Novel, Unimolecular GLP-1 and Amylin Receptor Agonist: Results of a Phase 1b/2a Clinical Trial. Poster 2002-LB. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025. The Lancet: Gasiorek A, Heydorn A, Gabery S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, randomised, placebo-controlled study. Novo Nordisk Company Announcement. Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development. Available at: Attachment PR250621-ADA-AmycretinError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data