Spondylarthropathies

MONTREAL, March 15, 2024 /CNW/ - Pharmascience Canada is proud to announce the launch of pms- METHOTREXATE INJECTION (methotrexate injection) 50 mg/ml, a drug indicated for the treatment of psoriasis, psoriatic arthritis and rheumatoid arthritis in adults aged 18 to 65 with severe disabling conditions, when other treatments do not work. This treatment, administered subcutaneously via a single-use pre-filled syringe, helps control psoriasis (skin disease), psoriatic arthritis (joint inflammation that affects people with psoriasis), and rheumatoid arthritis (joint inflammation caused by the immune system) without curing them. pms-METHOTREXATE INJECTION 50 mg/ml is available in boxes of one syringe in the following dosage forms: pms-METHOTREXATE INJECTION (methotrexate injection) 50 mg/ml (as methotrexate sodium), available in single-use pre-filled syringes. Available in 7 doses that are color-coded containing 0.2 ml, 0.25 ml, 0.3 ml, 0.35 ml, 0.4 ml, 0.45 ml and 0.5 ml of solution for injection equivalent to 10 mg, 12,5 mg, 15 mg, 17,5 mg, 20 mg, 22, 5 mg and 25 mg methotrexate, respectively. This medication is a generic equivalent of PrMETOJECT® SUBCUTANEOUS. Syringes of pms-METHOTREXATE INJECTION are available at affordable prices. "Pharmascience is proud to bring to market pms-METHOTREXATE INJECTION 50mg/ml, a very exciting extension to our Methotrexate line of products AND another product manufactured and produced locally! pms-METHOTREXATE INJECTION 50mg/ml, a Disease Modifying Antirheumatic Drug is used in the treatments of psoriasis and rheumatoid arthritis. With the launch of this locally produced product, we demonstrate our focus on delivering the highest level of quality while growing our portfolio with the essential medicines needed by all Canadians." - Mike Dutton, Vice-President and General Manager of Pharmascience Canada. ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2024, the company was awarded Great Place to Work certification for the third year running. PrMETOJECT® SUBCUTANEOUS is a registered trademark owned by Medexus Pharmaceuticals, Inc. in Canada. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. SOURCE Pharmascience Inc.

BIMZELX® (bimekizumab) is the first and only treatment approved by Health Canada for eligible patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) that directly and selectively inhibits two key inflammatory proteins, IL-17A and IL-17F.1 Health Canada's approval is supported by Phase III clinical trial data which found BIMZELX provided significant improvement across key disease severity indicators.2,3,4 The approval of BIMZELX for adults with active PsA or axSpA demonstrates UCB's ongoing commitment to advancing science in immuno-dermatology and rheumatological conditions, addressing unmet patient needs and improving clinical outcomes. OAKVILLE, ON, March 14, 2024 /CNW/ - Today, UCB Canada Inc. is pleased to announce that BIMZELX® (bimekizumab injection) has received authorization from Health Canada for two new indications. On February 23, 2024, BIMZELX was approved for the treatment of adults with active psoriatic arthritis (PsA) and on March 11, 2024, the therapy also received approval for the treatment of adults with axial spondyloarthritis (axSpA). BIMZELX is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. This medicine works by reducing the activity of two proteins called IL-17A and IL-17F, which are present at increased levels in diseases such as PsA and axSpA.1 BIMZELX is also the first and only biologic that directly inhibits both IL-17A and IL-17F to be approved in Canada. "We are delighted with the approval of BIMZELX in Canada for both psoriatic arthritis and axial spondyloarthritis, and its first marketing authorization for these new indications in North America," said Lionel Houle, Head of Immunology, UCB Canada. "This follows our first product approval in moderate to severe plaque psoriasis. Our sights are set on innovative scientific solutions that can raise the standard of care in the lives of patients. We are proud to bring this new treatment option to people living with these illnesses in Canada, and believe that BIMZELX has the potential to help many patients living with the painful and debilitating symptoms of both conditions." Both Health Canada approvals are based on Phase III data which supports BIMZELX's role as an innovative treatment option for patients with PsA and axSpA, including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA)).2,3,4 "Psoriatic arthritis is an inflammatory arthritis which affect people with psoriasis. It leads to pain and swelling in the joints, and often results in joint damage, deformities and reduced quality of life and function," explained Dr. Dafna Gladman, Professor of Medicine, University of Toronto and Senior Scientist, Schroeder Arthritis Institute, Krembil Research Institute. "While there are already approved medications for psoriatic arthritis, they do not work for all patients. Bimekizumab is a novel biologic medication which works very well for both psoriasis and psoriatic arthritis. It is exciting for both patients and health care providers that this medication is now added to the current treatment of psoriatic arthritis." "Axial spondyloarthritis is a chronic, painful, inflammatory disease involving the axial skeleton, which significantly impacts patients' mobility, function, and quality of life," said Dr. Proton Rahman, Distinguished Professor, Memorial University and Chief of Rheumatology, Newfoundland and Labrador Health Services. "Primary results from the two Phase 3 studies, BE MOBILE 1 and 2, have convincingly demonstrated that bimekizumab, a novel monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, results in rapid improvement in axial spondyloarthritis symptoms. Bimekizumab marks a significant breakthrough in the management of axial spondyloarthritis and provides hope and relief for many living with this debilitating disease." BIMZLEX was previously approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 About Psoriatic Arthritis Psoriatic arthritis (PsA) is both an autoimmune disease and a form of inflammatory arthritis. The immune systems of people with PsA attack the joints, in addition to the skin. It is estimated that 0.2 per cent of adults in Canada have PsA, but the exact numbers are unknown. PsA can develop at any age and up to a third (approximately 30 per cent) of people with psoriasis will develop PsA in their lifetime.5 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA) is a chronic, progressive, painful form of inflammatory arthritis that causes significant and long-lasting pain in the lower back, buttocks and hips.6 axSpA can occur at any age, but typically begins between ages 20 and 40.7 Estimates suggest as many as one per cent of the Canadian adult population lives with a form of axSpA known as ankylosing spondylitis (AS).8 BIMZELX Clinical Program Health Canada's approval of BIMZELX for the treatment of adults living with active PsA was based on two multicentre, randomized, double-blind, placebo-controlled studies: BE OPTIMAL: evaluated 852 patients not previously exposed to any biologic disease-modifying anti-rheumatic drug (bDMARD-naïve) for the treatment of psoriasis or PsA2 BE COMPLETE: evaluated 400 patients with an inadequate response or intolerance to treatment with one or two tumour necrosis factor alpha inhibitors (TNFi-IR) for either psoriasis or PsA3 According to the results of both trials, bimekizumab treatment demonstrated positive outcomes at Week 16 vs placebo. The safety pro bimekizumab was consistent with previous Phase III studies in patients with plaque psoriasis, and with IL-17A inhibitors. In BE OPTIMAL, the most frequent treatment-emergent adverse events (TEAEs) (3 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, upper respiratory tract infection, headache, diarrhoea, oral candidiasis, pharyngitis and hypertension.2 In BE COMPLETE, the most frequent TEAEs (2 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, oral candidiasis and upper respiratory tract infection.3 Health Canada's approval of BIMZELX for the treatment of axSpA was based on two multicentre, randomised, double-blind, placebo-controlled studies: BE MOBILE 1: evaluated 254 patients with non-radiographic axSpA (nr-axSpA) BE MOBILE 2: evaluated 332 patients with ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA))4 In both trials, dual inhibition of IL-17A and IL-17F with bimekizumab resulted in improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA. The most frequently reported TEAEs (3 per cent or more in any bimekizumab group in either trial) up to Week 16 were nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis.4 More information about BIMZELX can be found by accessing the product monograph. About UCB Canada Inc. Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult . About UCB UCB, Brussels, Belgium ( ) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. References SOURCE UCB Canada Inc.

LUND, SE / ACCESSWIRE / March 14, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm:CANTA) today reported new data highlighting the potential of the CAN10 antibody, currently in phase I clinical development, as therapy in systemic sclerosis. All signaling systems targeted by CAN10 (IL-1, IL-33 and IL-36) were found to be highly upregulated in patient skin biopsies. These cytokines induce fibrosis in skin fibroblasts isolated from patients, and this manifestation of disease was blocked by CAN10. In mouse models, CAN10 reversed the aberrant expression of several genes involved in the systemic sclerosis pathogenesis in humans. The data is presented at the Systemic Sclerosis World Congress in Prague 14-16 March 2024. "We are very excited about the progress in the CAN10 program which is quickly advancing from the ongoing healthy volunteer investigations towards studies in patients. The new data provides important information further increasing our confidence in CAN10 as a future therapy of inflammatory diseases" said Göran Forsberg, CEO of Cantargia. CAN10 is currently in phase I clinical development with transition from healthy volunteers to patients planned for Q3, 2024. One of the lead indications, systemic sclerosis, is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Current treatments focus on symptomatic treatment rather than addressing underlying disease mechanisms. It is estimated that in the US, approximately 100,000 patients suffer from the disease. CAN10 has orphan drug status in the US for treatment of systemic sclerosis. The new results demonstrate that both the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients. This disease develops as fibroblasts promote the formation of an excessive buildup of connective tissue in skin and internal organs, so-called fibrosis. The results show that IL-1, IL-33 and IL-36 collagen production on skin fibroblasts from systemic sclerosis patients, leading to fibrosis. These disease-associated mechanisms can be reduced by CAN10. These new data strengthen previously reported beneficial effects of IL1RAP-blockade in three mouse models of systemic sclerosis, where treatment with a mouse surrogate of CAN10 reduced both skin and lung fibrosis. Additional gene expression analysis of mouse systemic sclerosis skin showed decreased expression of several key disease-related profibrotic factors in the skin by CAN10. In summary, the data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides an opportunity to treat underserved systemic sclerosis patients. These data were generated in collaboration with a world-leading research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany and will be presented as a poster at the 8th Systemic Sclerosis World Congress March 14-16, 2024 in Prague, Czech Republic. The poster is now also available at Cantargia's web page . Title: Combined blockade of IL-1, IL-33 and IL-36 signaling by targeting IL1RAP ameliorates skin and lung fibrosis in preclinical models of systemic sclerosis Session Title: Innovative therapies Session Date and Time: Friday March 15th 1.30-2.30 pm and Saturday March 16th 1-2 pm Poster Number: 317 This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-03-14 17:31 CET. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . About CAN10 The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In preclinical in vivo models of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. The CAN10 surrogate also inhibited disease development in models of systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis and peritonitis. A clinical phase I study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Up to 80 subjects may be included in the trial, the first clinical data set shows good safety. Additional data from the trial are expected continuously during 2024. Attachments Cantargia presents new human data further supporting CAN10 in the treatment of systemic sclerosis SOURCE: Cantargia View the original press release on accesswire.com