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Medscape
4 days ago
- Health
- Medscape
Fitness Levels Impaired in Patients With Paediatric IBD
Patients with paediatric inflammatory bowel disease (IBD) exhibited lower cardiorespiratory and neuromuscular fitness than healthy matched control participants. Higher body mass index (BMI) for children and adolescents was negatively associated with cardiorespiratory fitness, while the use of any biologic medication was positively associated. METHODOLOGY: This cross-sectional case-control study assessed cardiorespiratory and neuromuscular fitness in patients with paediatric IBD aged 6-17 years. This study included 73 patients with paediatric IBD (mean age, 13 years; 56.2% girls; 31 with Crohn's disease [CD]; 42 with ulcerative colitis [UC] and IBD unidentified) from two tertiary centres in Finland and 73 age- and sex-matched healthy control children from an ongoing study and registry. Clinical disease activity was determined using the Pediatric Ulcerative Colitis Activity Index for UC and using the Pediatric Crohn's Disease Activity Index for CD along with the Physician's Global Assessment, and physical activity was evaluated using a questionnaire covering various activities over the past 12 months. Cardiorespiratory fitness was measured with a maximal exercise test on a cycle ergometer. Peak oxygen uptake (VO2peak) and maximal workload (Wmax) divided by body weight were considered as measures of cardiorespiratory fitness. Neuromuscular fitness was also assessed using various tests. TAKEAWAY: All patients with CD were in remission or had mild disease activity, whereas 69% of patients with UC were in remission and only one had a severe disease. Patients with paediatric IBD had significantly lower cardiorespiratory fitness, with lower Wmax/kg ( P = .007) and VO2peak/kg ( P < .001) than control participants. = .007) and VO2peak/kg ( < .001) than control participants. Neuromuscular fitness was also reduced in patients with paediatric IBD, with lower performance than control participants in sit-up, long jump, and hand grip strength tests ( P = .001 for all). = .001 for all). In the multivariate analysis, higher age‐ and sex‐adjusted BMI for children and adolescents was associated with lower Wmax/kg and VO2peak/kg ( P < .001 for both), while the use of any biologic medication was linked to higher Wmax/kg ( P = .025) and VO2peak/kg ( P = .006). IN PRACTICE: "Lower physical fitness has been associated with poorer disease control, impaired quality of life, and increased risk of cardiovascular diseases in PIBD [paediatric IBD]. This emphasizes the importance of assessing and improving physical fitness in these patients as a part of their multidisciplinary treatment," the authors wrote. SOURCE: This study was led by Saija Kantanen, Tampere University Hospital, Tampere, Finland. It was published online on May 30, 2025, in the Journal of Pediatric Gastroenterology and Nutrition . LIMITATIONS: Some data from the control group were collected previously, and changes in physical activity levels over time may have affected the results. Additionally, the duration of the disease in patients was short, and the design was cross-sectional. DISCLOSURES: This study was supported by the Foundation for Pediatric Research; the State Funding for University-level Health Research, Tampere University Hospital, and Wellbeing Services County of Pirkanmaa; the Päivikki and Sakari Sohlberg Foundation; and the Finnish Foundation for Cardiovascular Research. The authors declared having no relevant conflicts of interest.
Yahoo
29-05-2025
- Business
- Yahoo
Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring Biologics Switching Treatment for Psoriasis Patients with Prior Inadequate Response to Anti-IL-17 Antibodies
SAN FRANCISCO and SUZHOU, China, May 28, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical study of picankibart (recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, R&D code: IB112). This study is the first randomized, double-blind, controlled Phase 3 clinical study evaluating biologics switching in psoriasis patients with prior inadequate response to anti-IL-17 antibody. This study will evaluate the efficacy of picankibart in difficult-to-treat psoriasis patients who had inadequate response to prior anti-IL-17treatment, with the control group continuing to receive IL-17 inhibitors. The results are expected to provide robust clinical evidence supporting picankibart's therapeutic advantages in this challenging patient population. This study (NCT06945107) is a multi-center, randomized, double-blind, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of switching to picankibart in plaque psoriasis patients with inadequate response to prior anti-IL-17 monoclonal antibody treatment (sPGA score of ≥ 2 and body surface area [BSA] of ≥3%). This study plans to enroll approximately 310 participants, who will be randomized in a 1:1 ratio to the picankibart treatment group or the continued IL-17 monoclonal antibody treatment group. The primary endpoint is the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16. The results of a Phase 2 study (NCT05970978) showed that switching from other biologics (primarily IL-17 monoclonal antibodies) to picankibart led to a rapid clinical response. The observed efficacy in skin lesion clearance and significant improvements on the quality of life suggest picankibart may possess a best-in-class profile among agents with the same target. Nearly half (48.2%, 40/83) of the participants with inadequate response to prior biologics treatment reached the primary endpoint, i.e., sPGA 0 or 1 and BSA < 3%, and the response rate remained stable (54.2%, 45/83) through week 44 with continued picankibart maintenance treatment dosing every 12 weeks. The majority (64.6%, 42/65) of the participants with baseline sPGA ≥ 2 and BSA ≥ 3% achieved sPGA of 0 or 1, and 16.9% (11/65) of the participants achieved complete skin lesion clearance, i.e., sPGA of 0. The DLQI of the participants was also improved. Professor Furen Zhang, the Principal Investigator of the Clinical Study, Dermatology Hospital Affiliated to Shandong First Medical University, stated, "Psoriasis is a chronic condition that significantly affects patients' physical and mental well-being and quality of life. At present, biological agents have emerged as cornerstone systemic therapies for psoriasis, particularly IL-17 monoclonal antibodies due to their efficacy in patients with moderate-to-severe psoriasis. Nonetheless, treatment failure remains a significant clinical challenge. A real-world study showed that 28.5% of patients discontinued therapy due to primary failure (failing to meet the minimum efficacy criteria after 12 weeks of treatment), while 24.3% of patients experience secondary failure (failing to maintain a satisfactory quality of life when the efficacy of an effective biologic was attenuated)1. For patients experiencing treatment failure, there is an urgent medical need for optimized treatment strategy. This randomized controlled Phase 3 study will evaluate the efficacy and safety of picankibart in patients with inadequate response to previous IL-17 monoclonal antibody treatment. I will collaborate closely with all investigators to ensure successful study completion. This trial will generate robust clinical evidence supporting biologic switching strategies in psoriasis treatment while potentially establishing a valuable new treatment option for the majority of patients with psoriasis." Professor Jun Gu, the Principal Investigator of the Clinical Study, Suzhou Municipal Hospital, stated, "Although the IL-17 monoclonal antibody has shown significant efficacy for the treatment of psoriasis, there are still patients who will discontinue treatment due to poor efficacy or safety issues. A study on the biologics switching for psoriasis implied that the switching between biologics with different targets may provide better efficacy to patients2, but rigorous clinical research evidence remain essential to validate this therapeutic approach. Extensive clinical data have demonstrated the therapeutic benefits of picankibart in psoriasis treatment. This randomized controlled Phase 3 study addresses a critical unmet need by evaluating picankibart as an alternative treatment for patients with inadequate response to IL-17 inhibitors. It aims to transform treatment failures into new starting points for optimized treatment pathways, providing scientific evidence for clinical decision-making, while also offering new hope of maintaining quality of life for patients who have experienced treatment setbacks." Dr. Lei Qian from Innovent Biologics, stated, "With the wide application of biological agents, the failure of biological agents has gradually become an important clinical problem, which needs to be solved urgently. A completed Phase 2 single-arm study suggested that in patients with inadequate response to previous treatment with other biologics (mainly anti-IL-17 antibodies), up to 64.6% of patients achieved skin lesion clearance after 16 weeks of treatment with picankibart. This head-to-head Phase 3 randomized, double-blind clinical study will compare picankibart with IL-17 monoclonal antibody to strengthen picankibart clinical benefits for patients with inadequate response. I look forward to the success of this study, which will provide strong evidence and guidance for the clinical practice of psoriasis biologics switching. As the first IL-23p19 monoclonal antibody independently developed by a Chinese biopharma, picankibart's first new drug application for the treatment of moderate-to-severe plaque psoriasis has been submitted for the review by NMPA in September 2024, aiming to provide more treatment options for patients with psoriasis as soon as possible." About Psoriasis Psoriasis is a chronic, recurrent, inflammatory and systemic disease induced by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately 80%~90% of patients have plaque psoriasis, with nearly 30% of the cases being moderate-to-severe. Global psoriasis prevalence varies significantly, with over 7 million patients in China alone. Current systemic treatments in China include methotrexate (MTX), cyclosporine A, retinoic acids, small molecule target agents and biological agents. Since 2019, biologics have become a central focus in psoriasis treatment, with IL-23 inhibitors standing out due to their rapid onset, robust efficacy, good safety, and long-lasting effects, which are more advantageous in comprehensive and deep lesion clearance and prolonging relapse-free periods. About Picankibart (IBI112) Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases. Currently, multiple clinical studies of picankibart are underway, including: Phase 3 study conducted in patients with moderate-to-severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024; Phase 3 study conducted in patients with moderate-to-severe plaque psoriasis with randomized withdrawal and re-treatment; Phase 3 study in patients with moderate-to-severe plaque psoriasis who were previously treated with biologics; Phase 2 study in patients with moderate-to-severe active ulcerative colitis; In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate-to-severe plaque psoriasis. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit or follow Innovent on Facebook and LinkedIn. Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s). (2)Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. REFERENCES: 1. Gulliver SR, Gulliver W. Investigation of prevalence of biologic use and discontinuation rates in moderate-to-severe psoriasis patients in Newfoundland and Labrador using real-world data. Dermatol Ther. 2021;34(3):e14944 2. Tsai YC, Tsai TF. Switching biologics in psoriasis - practical guidance and evidence to support. Expert Rev Clin Pharmacol. 2020;13(5):493-503. View original content: SOURCE Innovent Biologics
Yahoo
21-05-2025
- Business
- Yahoo
Accropeutics Announces Positive Data from Phase 2 Trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, for the treatment of Moderate-to-Severe Plaque Psoriasis
Phase 2 primary endpoint of PASI-75 and key secondary endpoints met in all of the three dosing groups at Week 12 AC-201 was generally well tolerated at all dose levels with no SAEs or AEs leading to discontinuation Efficacy and safety findings from this Phase 2 trial support advancing AC-201 into Phase 3 development for plaque psoriasis. NEW YORK and SUZHOU, China, May 20, 2025 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited (Accropeutics), a clinical-stage biotech company focused on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, today announced positive results from their Phase 2 clinical trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, in moderate-to-severe plaque psoriasis. Primary and key secondary endpoints including Psoriasis Area and Severity Index (PASI)-75, PASI-90(≥75% and 90% reduction in PASI) and static Physician's Global Assessment (sPGA)-0/1 (score of 0 'clear' or 1 'almost clear') were achieved following 12 weeks of treatment in all 3 dosing groups of AC-201. This multicenter, randomized, double-blind, placebo-controlled trial randomized (1:1:1:1) 145 Chinese patients with moderate to severe plaque psoriasis to receive AC-201 25mg BID, 50mg BID or 100mg QD versus placebo. The primary endpoint was PASI-75 at Week 12. At week 12, PASI-75 response rates were 8.1% for placebo (PBO), 31.4% for 25mg BID (P=0.012 vs. PBO), 74.3% for 50mg BID (P<0.001 vs. PBO), and 59.5% for 100mg QD (P<0.001 vs. PBO). The PASI-90 response rate was 2.7% for placebo, 20% for 25mg BID (P=0.02 vs. PBO), 48.6% for 50mg BID (P<0.001 vs. PBO), and 24.3% for 100mg QD (P=0.007 vs. PBO). The percent of patients achieved sPGA-0/1 were 5.4% for placebo, 71.4% for 50mg BID (P<0.001 vs. PBO), 59.5% for 100mg QD (P<0.001 vs. PBO), and 31.4% for 25mg BID (P=0.004 vs. PBO). Treatment with AC-201 was well tolerated. There was no serious adverse event (SAE) or AE leading to permanent discontinuation in the study. Majority of treatment emergent adverse events (TEAEs) were mild or moderate in severity. The most common TEAEs reported were upper respiratory tract infection and hypertriglyceridemia. Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, said, "We are excited to see the positive results from the phase II study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases." About AC-201 AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudo kinase domain (JH2) of TYK2/JAK1, without having any effects on the JAK2/JAK2 signaling pathway. It is currently being developed to treat immune mediated inflammatory diseases such as psoriasis and systemic lupus erythematosus. AC-201 has successfully completed long-term nonclinical in vivo toxicology testing, including reproductive toxicity. Phase 1 studies of AC-201 in healthy volunteers conducted in Australia and China demonstrated an excellent safety and tolerability profile, supporting advancement into Phase 2. These studies showed dose proportional PK, no significant drug accumulation upon multiple dosing, and absence of clinically relevant food effect. Low to middle doses of AC-201 were effective in inhibiting disease causing pro-inflammatory cytokines, consistent with AC-201's mechanism of action. About Accropeutics Accropeutics is a clinical-stage biotech company with core focus on the molecular mechanisms of regulated cell death and related pathogenesis in human diseases. The company has developed a robust portfolio of innovative drug candidates spanning from lead optimization to clinical development. The RIPK1 inhibitor AC-003 had completed phase 1 clinical trials in China and the United States, obtained Orphan Drug Designation from the FDA, and is currently in a phase 1b trial for the treatment of aGVHD patients. The RIPK2 inhibitor AC-101 completed phase 1 testing in Australia and China with excellent safety and PK/PD data, and the 1b trial in UC patients is ongoing. AC-201, a selective TYK2/JAK1 inhibitor with therapeutic potential across a broad range of immune mediated inflammatory diseases, has completed a phase 2 clinical trial in Psoriasis with first-rate efficacy and safety findings. Accropeutics owns global rights of all the abovementioned assets with 24 patents issued in China, Japan, Korea, US and EU. Contact: info@ View original content: SOURCE Accropeutics 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
