Latest news with #axSpA
Yahoo
4 days ago
- Health
- Yahoo
Greywolf Therapeutics begins dosing of the first treatment to target the antigenic source of autoimmunity
This is the first ever autoimmunity study to evaluate a potential functional cure that targets the antigenic source – the origin of autoimmune disease The Phase 1/2 study (up to 141 participants) will evaluate the safety, tolerability and efficacy of GRWD0715 in healthy volunteers and participants with axial spondyloarthritis (axSpA) GRWD0715 is an investigational small molecule designed to interrupt T-cell activation by inhibiting the peptide processing enzyme ERAP1 (Endoplasmic Reticulum Aminopeptidase 1) AxSpA has no cure and affects an estimated 0.5–1.4% of the global population - millions worldwide - leading to chronic inflammatory back pain, spinal stiffness, and significant disability if untreated OXFORD, United Kingdom, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Greywolf Therapeutics, the clinical-stage biotech company advancing novel antigen modulation technology to guide the immune system, have successfully dosed the first healthy volunteer in their Phase 1/2 trial (NCT07047703) evaluating GRWD0715, an oral ERAP1 inhibitor, for the treatment of axial spondyloarthritis (axSpA). 'The strong genetic association between ERAP1 and axSpA make it a very compelling primary indication for our first autoimmunity trial, and we're excited by the impact we could deliver to this underserved community,' said Tom Lillie, Chief Medical Officer at Greywolf Therapeutics. 'Whilst current therapies seek to suppress various inflammatory mediators produced by activated T cells, we're taking a distinctly different approach with our program and aim to target the source of disease by interrupting autoantigen presentation, preventing the damaging T-cell response from continuing.' A Media Snippet accompanying this announcement is available by clicking on this link. In people living with axSpA, the immune system mistakenly recognizes the body's own proteins as foreign and attacks healthy tissue, particularly in the spine and sacroiliac joints. In vitro models have shown that GRWD0715 modulates cell-surface antigens, removing the target antigen incorrectly recognized in axSpA patients and preventing T cells from attacking healthy tissue. The Phase 1 component of the study will evaluate the safety and tolerability of GRWD0715 in healthy volunteers (up to 24 participants) and people living with axSpA (up to 36 participants). Findings from this part of the study will be used alongside proof-of-mechanism data to identify the biologically active dose for progression into the Phase 2 arm of the trial. 'We believe GRWD0715 represents a turning point in the treatment paradigm for autoimmune diseases like axSpA, offering the possibility of a functional cure by targeting the disease at its antigenic source,' said Peter Joyce, CEO and Co-founder of Greywolf Therapeutics. 'Dosing the first participant in this trial marks a major milestone for the company, testing the power of our antigen modulation approach to treat axSpA and bringing us closer to our goal of addressing significant unmet need in autoimmune diseases.' About GRWD0715 GRWD0715, a first-in-class ERAP1 inhibitor, is a selective, potent small molecule developed into an oral, once daily medicine. ERAP1 trims antigens from bacterial and viral infections, leading to their presentation on the surface of cells and triggering an immune response to clear the threat. In axSpA, it is hypothesized that a peptide from a normal protein in the person's own cells (called a 'self-antigen') is processed via this ERAP1 trimming pathway and incorrectly recognized by the body's T cells as foreign, causing an immune reaction. In addition to Greywolf Therapeutic's preclinical data, recent scientific evidence strongly supports the role of this antigen/self-antigen presentation pathway driven by ERAP1, in the pathological stimulation of the immune system causing the inflammatory symptoms experienced by people living with axSpA. GRWD0715 is designed to stop presentation of this self-peptide by inhibiting the ERAP1 enzyme, removing the stimulus for the immune system and the downstream inflammatory events. It has the potential to significantly reduce the symptoms experienced by people living with axSpA and halt disease progression. About axSpA Axial spondyloarthritis (axSpA) is a chronic immune-mediated inflammatory disease affecting mainly the spine and sacroiliac joints, causing persistent back pain and stiffness, and presenting generally before the age of 40. It affects ~0.5–1.4% of the population, with over 80% of cases in HLA-B27–positive individuals. Men and women are affected roughly equally, though forms of axSpA that cause changes in X-rays of the SI joints (radiographic axSpA) are more common in men. Symptoms may also involve hips, peripheral joints such as knees, wrists, shoulders and others, as well as extramusculoskeletal manifestations such as eyes (uveitis), skin (psoriasis), or the gut (inflammatory bowel diseases). There's no cure, but NSAIDs, biologics, tsDMARDs and non-pharmacological therapy help reduce pain, control inflammation, and maintain mobility to prevent long-term spinal damage. About Greywolf Therapeutics Greywolf Therapeutics is a clinical-stage biotech company advancing novel antigen modulation technology to guide the immune system. Greywolf's technology modulates antigen presentation, flicking a switch inside cells to alter their appearance to the immune system. They are progressing first-in-class antigen modulators to treat people living with autoimmune disorders, cancer and infectious diseases. Greywolf is headquartered in Oxford, UK. More information: | LinkedIn CONTACT: Media enquiries Greywolf Therapeutics Patrick White, Head of Communications +44 (0) 01235 644 970
Yahoo
28-07-2025
- Business
- Yahoo
Filgotinib Shows Positive Topline Results Across Full Spectrum of Axial Spondyloarthritis in OLINGUITO Phase 3 Study
Alfasigma plans to submit data from the OLINGUITO Phase 3 clinical trial to European Medicines Agency (EMA) and UK's Medicines Healthcare products Regulatory Agency (MHRA) to seek market authorization for filgotinib in the treatment of adults with active axial spondyloarthritis (axSpA). Filgotinib, an oral, once-daily JAK1 preferential inhibitor, met the primary endpoint in the OLINGUITO Phase 3 clinical trial, demonstrating efficacy across the full spectrum of axSpA (r-axSpA and nr-axSpA). The safety profile was consistent with previous filgotinib studies, with no unexpected events observed. AxSpA is a chronic inflammatory disease primarily affecting young adults, typically emerging during the third decade of life, with only 40-50% of patients with axSpA achieving adequate response with current treatments. If approved, filgotinib would offer a new oral treatment option for patients with axSpA expanding the treatment landscape in a therapeutic area marked by significant unmet needs. BOLOGNA, Italy, July 28, 2025--(BUSINESS WIRE)--Alfasigma S.p.A today announced positive topline results from the OLINGUITO Phase 3 clinical trial (NCT05785611; Eudra CT 2022-501354-10-01),i evaluating filgotinib (marketed as Jyseleca® in approved indications) to treat adult patients with active axial spondyloarthritis (axSpA). Filgotinib, an oral, once-daily JAK1 preferential inhibitor, met the primary endpoint in the OLINGUITO Phase 3 clinical trial in active axSpA. Efficacy was demonstrated across the full spectrum of axSpA, including both radiographic (r-axSpA) and non-radiographic (nr-axSpA) forms. The safety profile was consistent with previous studies, with no unexpected events Filgotinib is currently approved for the treatment of moderate to severe active rheumatoid arthritis (RA) and ulcerative colitis (UC).iii "These positive OLINGUITO topline results demonstrate filgotinib's potential to address this critical unmet need for patients with axial spondyloarthritis, with only half responding adequately to current therapies," said Daniele D'Ambrosio, Chief Development Officer at Alfasigma. "Based on these encouraging results, we intend to submit for an extension of filgotinib's current indications, offering a potential new treatment option for patients with axial spondyloarthritis who often struggle with debilitating symptoms from a young age. We thank all patients, investigators and staff at study sites whose participation made this important achievement possible." "These results from the OLINGUITO Phase 3 clinical trial clearly support the potential of filgotinib as a treatment option for patients living with axSpA at all stages of the disease. The burden of disease for these patients remains high as treatment options are limited. It is therefore encouraging that the primary endpoint for both axSpA indications was met in dedicated studies," said Professor Xenofon Baraliakos, Head of Rheumatology at the Rheumazentrum Ruhrgebiet, Herne, Germany, Professor for Internal Medicine and Rheumatology at the Ruhr-University Bochum, Germany. AxSpA is a chronic inflammatory disease primarily affecting young adults, typically emerging during the third decade of life. It primarily affects the axial skeleton (spine and sacroiliac joints) causing significant pain, stiffness and reduced Despite several efficacious anti-inflammatory treatment options, only about 40% to 50% of patients with axSpA achieve a relevant treatment response, and an even smaller proportion (approximately 10%-20%) reach remission or an inactive disease activity state within 16 to 24 weeks of treatment initiation.v About OLINGUITO The OLINGUITO Phase 3 clinical trial (NCT05785611; Eudra CT 2022-501354-10-01) was designed – in compliance with the European Medicines Agency's (EMA) guidelines – to evaluate the efficacy and safety of filgotinib in patients with active axial spondyloarthritis (axSpA). OLINGUITO was preceded by the TORTUGA Phase 2 clinical trial (NCT03117270), a randomized, double-blind, placebo-controlled clinical trial that demonstrated the safety and efficacy of filgotinib in adult patients with moderately to severely active ankylosing spondylitis (also known as r-axSpA, i.e., the damage caused by the disease can be seen on X-rays).vi The first patient entered the OLINGUITO Phase 3 clinical trial in April 2023. The trial consisted of two randomized, double-blind, multi-center, parallel-group studies of patients with active axSpA who had an inadequate response to conventional or biological treatments. Study A included 258 patients with r-axSpA, while study B included 237 patients with non-radiographic axSpA (nr-axSpA, i.e., the patient had symptoms of axSpA but damage was not yet visible on X-rays). After enrollment, patients in each study were randomized (1:1) to receive treatment with oral filgotinib 200 mg, or matching placebo, once daily for 16 weeks. The primary endpoint for both studies was the proportion of patients who achieved an Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) at Week Thereafter, patients without risk factors entered an open-label treatment period in which they received filgotinib 200 mg once daily up to Week 52. Patients from study A and study B who achieved sustained low disease activity or inactive disease during the open-label period were re-randomized (1:1) at Week 52 to receive double-blind filgotinib 100 mg or 200 mg up to Week 104. In patients above 65 years of age and those with increased risk factors for cardiovascular disease or malignancies, at Week 16 in the case of achievement of disease control after treatment with 200 mg once daily, the dose was reduced to 100 mg once daily for up to Week 104. All patients receiving filgotinib 100 mg daily had the option to increase to 200 mg daily in case of flares. Week 52 visits for all patients were completed in May 2025. After Week 104, select eligible patients who achieve ASAS40 response without high disease activity, per investigators' judgment, will enter the Open Label Extension (OLE) study. This OLE is designed to collect additional long-term safety and efficacy data for a duration of approximately 2.5 years. About Filgotinib Filgotinib (marketed as Jyseleca®) is currently approved by the relevant regulatory authorities in the European Union, United Kingdom, Japan, Taiwan, South Korea and Singapore. In Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore, filgotinib is approved for the treatment of moderate to severe active rheumatoid arthritis in adults who have not responded adequately or cannot tolerate other disease modifying anti-rheumatic drugs (DMARDs). Filgotinib is also approved in Europe, United Kingdom, Japan Taiwan, South Korea and Singapore for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Filgotinib 100mg and 200mg are registered in the above-mentioned territories. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at The United Kingdom Summary of Product Characteristics for filgotinib can be found at The interview form from the Japanese Ministry of Health, Labor and Welfare is available at The Taiwan Food and Drug Administration Assessment Report for filgotinib can be found at The Korean Ministry of Food and Drug Safety report on filgotinib can be found here The Singapore Summary of Product Characteristics for filgotinib can be found at About axial spondyloarthritis Axial spondyloarthritis (axSpA) is a chronic inflammatory condition that primarily affects the axial skeleton (spine and sacroiliac joints). While persistent back pain and spinal stiffness are common initial symptoms, the disease often also presents with peripheral manifestations such as enthesitis, arthritis, and dactylitis, as well as extra-musculoskeletal features including uveitis, inflammatory bowel disease and psoriasis. AxSpA comprises the whole spectrum of patients with and without radiographic sacroiliitis, that is, radiographic axSpA (r-axSpA; also known as ankylosing spondylitis, i.e., the damage caused by the disease can be seen on X-rays) and non-radiographic axSpA (nr-axSpA), respectively. AxSpA usually starts during the third decade of life; r-axSpA is more common in men than women, whereas there is an equal sex distribution among patients with About Alfasigma Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in several countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission, to provide better health and a better quality of life for patients, caregivers, and healthcare providers'. It focuses on three main therapeutic areas: Gastroenterology, Vascular and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals. For more information, please visit Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Alfasigma. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. Alfasigma assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References i OLINGUITO Clinical Trial (NCT05785611) Study Details | A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis | Accessed July 2025. ii The topline results of OLINGUITO Phase 3 clinical trial will become available in future scientific conferences and published in a peer-reviewed journal in due course. iii Accessed July 2025. iv Navarro-Compán V, et al., Axial spondyloarthritis. Lancet 2025; 405: 159–72 v Poddubnyy D, et al. Ann Rheum Dis 2025; 84(4): 538-546. doi: 10.1016/ vi Van der Heijde D, et al. Lancet 2018; 392(10162): 2378-2387. doi: 10.1016/S0140-6736(18)32463-2 vii J. Sieper, et al. Ann Rheum Dis. 2009 Jun:68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018. Based on the ASAS (Assessment of SpondyloArthritis International Society) assessment that includes four aspects (domains): patient global assessment, pain, function and inflammation. In order to meet ASAS40 response, 3 of the 4 domains should improve by at least 40% with a minimum 2-unit change on a scale of 0 to 10. For the remaining domain, there should be no deterioration (worsening) from baseline. View source version on Contacts Contact Press Office:Gea Annie Error 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
Medscape
04-07-2025
- Health
- Medscape
AxSpA Maintained OK via Remote Monitoring, Patient-Led Care
TOPLINE: Remote monitoring and patient-initiated care matched usual care in maintaining low disease activity in patients with axial spondyloarthritis (axSpA) on stable TNF inhibitor therapy. METHODOLOGY: Researchers conducted a randomized, noninferiority trial at a hospital in Norway between September 2021 and June 2022 to assess whether remote monitoring or patient-initiated care was noninferior to usual care in maintaining low disease activity in patients with axSpA. They enrolled 243 patients (mean age, 43 years; 75% men) with axSpA who had been on stable TNF inhibitor treatment for the past 6 months and had low disease activity (Axial Spondyloarthritis Disease Activity Score [ASDAS] < 2.1). Participants were randomly allocated to one of three groups: Patient-initiated care (n = 81): This arm did not include scheduled visits. Patients submitted their outcomes via a mobile application and contacted the rheumatology nurse if they felt worse. Remote monitoring (n = 80): This arm also did not include scheduled visits. A nurse reviewed the entries of patient-reported outcomes submitted through the application daily and decided whether an in-person visit was needed. Usual care (n = 82): Standard practice was followed, with face-to-face nurse-led visits under rheumatologist supervision every 6 months. The primary outcome was the probability of achieving low disease activity compared between groups at 6, 12, and 18 months, with a 15% noninferiority margin. TAKEAWAY: Both remote monitoring and patient-initiated care were noninferior to usual care, with estimated differences in the probability of achieving an ASDAS < 2.1 of -4.1% (97.5% CI, -9.9% to 1.8%) and -1.1% (97.5% CI, -7.2% to 4.9%), respectively. Patient-initiated care demonstrated noninferiority to remote monitoring, with a difference of 2.9% in the probability of achieving an ASDAS < 2.1 (95% CI, -1.5% to 7.4%). Secondary outcomes, including measures of disease activity, physical function, and patient satisfaction, were comparable across all groups, with ≥ 90% of patients reporting satisfaction. The number of adverse events was similar across groups. Few serious adverse events occurred, and none resulted in study discontinuation. IN PRACTICE: 'The lower resource use in patient-initiated care can liberate time for healthcare providers to care for patients with high disease activity or more complex diseases and thus facilitate more targeted use of healthcare resources in rheumatology,' the authors wrote. SOURCE: This study was led by Inger Jorid Berg, MD, Diakonhjemmet Hospital, Oslo, Norway. It was published online on May 23, 2025, in Annals of the Rheumatic Diseases. LIMITATIONS: Selection bias may have influenced results as patients motivated for alternative follow-up were more likely to participate. The open-label design and reliance on patient-reported outcomes could have been influenced by participants' enthusiasm for their assigned follow-up method. Using patient-reported outcomes as the main benchmark for clinical action in remote monitoring may affect interpretation of the results in this noninferiority trial. DISCLOSURES: This study received funding from South-Eastern Norway Regional Health Authority and The Research Council of Norway. Three authors reported receiving research grants, consulting fees, or other forms of financial or nonfinancial support from pharmaceutical companies, including AbbVie, Amgen, Biogen, Janssen, MSD, Pfizer, and UCB. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
30-06-2025
- Health
- Medscape
Golimumab Boosts Remission Rates in AxSpA
TOPLINE: Most patients with early, active axial spondyloarthritis (axSpA) achieved remission in a tight control treatment with golimumab, regardless of gut inflammation, in a small, single-arm study. METHODOLOGY: Researchers conducted a multicenter trial to evaluate the effectiveness of a tight control strategy with rapid escalation to TNF inhibition in early, active axSpA in relation to gut inflammation. They included 58 patients (mean age, 28.2 years; 41.4% women) who had an Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) ≥ 2.1 and less than 1 year of symptom duration. Patients took two different nonsteroidal anti-inflammatory drugs (NSAIDs) for 4 weeks and 50 mg golimumab every 4 weeks if needed to achieve inactive disease (ASDAS-CRP < 1.3) or improvement. The primary endpoint was the proportion of patients achieving sustained clinical remission (ASDAS-CRP < 1.3), determined at two consecutive visits with a 12-week interval. TAKEAWAY: Overall, 61.8% of patients achieved sustained clinical remission. Of the 72.7% who needed escalation to golimumab, 55% achieved sustained clinical remission. Microscopic gut inflammation was present in 28.6% of patients and was not predictive of achieving clinical remission (odds ratio, 1.50; 95% CI, 0.39-6.49). Relapse within 1 year occurred in 78.1% of patients who stopped treatment. Those who achieved sustained clinical remission with NSAIDs and golimumab had relapse rates of 91.7% and 70%, respectively. Male sex, no history of smoking, and lower disease activity were identified as predictors of sustained remission. IN PRACTICE: 'Our trial demonstrated that sustained inactive disease state is an achievable therapeutic goal in early axSpA,' the study authors wrote. SOURCE: This study was led by Zuzanna Łukasik, MD, and Ann-Sophie De Craemer, MD, PhD, Gent University Hospital, Gent, Belgium. It was published online on June 16, 2025, in Arthritis & Rheumatology. LIMITATIONS: A key challenge of the trial was recruiting patients with axSpA within the first year of symptom onset, resulting in a high screening failure rate. Additionally, repeated ileocolonoscopy at remission was performed in only a minority of patients, which limited analysis of the relationship between axial symptoms and gut inflammation. DISCLOSURES: This study received funding through a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp. Two authors reported receiving educational and research grants or personal fees from Merck Sharp & Dohme. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
23-06-2025
- Health
- Medscape
Do NSAIDs Affect Sacroiliitis Visibility on MRI in axSpA?
TOPLINE: Among patients with axial spondyloarthritis (axSpA) who showed active sacroiliitis on MRI after a washout of non-steroidal anti-inflammatory drugs (NSAIDs), complete resolution of MRI-visible sacroiliitis was seen in one fifth of cases, with close to half showing reduced inflammation after NSAID reintroduction. METHODOLOGY: Researchers conducted a non-randomised crossover trial across 34 centres in the UK between June 2017 and February 2020 to assess whether NSAIDs could mask active sacroiliitis on MRI in patients with axSpA. They recruited 311 patients with established or suspected axSpA and daily NSAID usage requiring sacroiliac joint MRI (median age, 42 years; 62% men; 87% White). Data on the clinical assessment were obtained. Participants underwent NSAID washout for 1-2 weeks before initial MRI (scan 1). Those who showed positive results for active sacroiliitis underwent a second scan (scan 2) at 6 weeks after resuming daily NSAIDs. Images were evaluated by two independent readers using the Leeds MRI scoring method, with scores suggesting no to severe sacroiliitis. The primary outcome was the proportion of patients with axSpA who had active sacroiliitis at scan 1 (off NSAIDs) that resolved at scan 2 after NSAIDs were reintroduced (on NSAIDs). TAKEAWAY: Among 286 patients who completed NSAID washout and underwent initial MRI, 146 showed active sacroiliitis, with follow-up scans obtained from 124 patients. Overall, 20.2% (95% CI, 13.5%-28.3%) of participants showed complete resolution of active sacroiliitis after NSAID reintroduction. Gender analysis showed no significant difference in the risk for sacroiliitis resolution between men and women. After NSAID reintroduction, 44% (95% CI, 35%-54%) of patients experienced a reduction in the Leeds score, suggesting improvement in severity. IN PRACTICE: "This provides evidence of the effect of NSAIDs on active sacroiliitis and shows that NSAID use prior to MRI may have an important impact on clinical diagnosis. Further, we show that, while patients may experience a deterioration in disease activity and spinal pain during NSAID washout, almost all patients who attempted NSAID washout were able to tolerate it. Thus, stopping NSAIDs for 1-2 weeks prior to MRI scanning in clinical practice should be considered," the authors wrote. SOURCE: This study was led by Gareth T. Jones, PhD, University of Aberdeen, Aberdeen, Scotland. It was published online on June 13, 2025, in Arthritis Care and Research. LIMITATIONS: The study protocol did not specifically state NSAID treatment, allowing participants to continue their prescribed medications and dosages. DISCLOSURES: This study received funding from Versus Arthritis. Five authors reported having financial ties, such as receiving grant support, honoraria, and consultancy, with multiple pharmaceutical companies, including AbbVie, Biogen, Eli Lilly, Novartis, Pfizer, UCB, Janssen, and others. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
