Fasudil mesylate

MONTREAL, June 17, 2024 /PRNewswire/ - Raya Therapeutic Inc., ("Raya") a mission-driven company focused on the treatment of ALS and other neurodegenerative diseases, is pleased to announce supportive clinical data for its lead compound, fasudil (RT1968, in the treatment of Amyotrophic Lateral Sclerosis (ALS)), as disclosed in a conference abstract for the ENCALS meeting by the investigators of the ROCK-ALS Phase 2 clinical trial. As shared in the conference abstract, the ROCK-ALS Phase 2 study was a randomized, double-blind, placebo-controlled trial that enrolled 120 patients across sites in Germany, France, and Switzerland. Subjects were randomly assigned (1:1:1) to receive 30 mg of fasudil, 60 mg of fasudil, or placebo intravenously (iv) over 20 treatment days. Assessments were performed at 45, 90 and 180 days after treatment initiation. Primary endpoints were tolerability and safety, and secondary endpoints included, among others, motor unit number index (MUNIX), which estimates how many motor neurons innervate a muscle, and slow vital capacity (SVC), which is a measure of respiratory function. In the intention-to-treat population (118 participants), safety and tolerability were not significantly different between groups. In the secondary outcomes, MUNIX showed a significantly reduced decline with Fasudil 60 mg at 26 and 90 days, and for Fasudil 30 mg at 90 days after treatment initiation. In addition, there was a directional difference in a slower loss of SVC favoring the 60 mg of fasudil treatment at day 26, which was statistically significant in a post-hoc subgroup analysis of females at all time points, as stated in the conference abstract. The authors, who include the principal investigators of this investigator-initiated trial, conclude the following regarding the results of this trial in the abstract: "Fasudil treatment was well tolerated and safe in ALS patients. MUNIX evaluation suggests a slower loss of motor units in fasudil-treated patients compared to placebo suggesting a benefit of fasudil to be explored in further clinical trials." These preliminary results were shared in the conference abstract and have not yet been peer-reviewed. "We are excited by the encouraging data from the ROCK-ALS trial of fasudil and remain steadfast in our mission to develop breakthrough therapies for ALS and other neurodegenerative disorders," said Anjan Aralihalli, President and founder of Raya. Based on these encouraging findings, Raya will now test fasudil in more extensive studies with a larger patient cohort to further assess the compound's efficacy in ALS. In addition, Raya has reformulated fasudil into a novel formulation to enhance ease of use, especially for the approximately 80% of ALS patients that suffer from dysphagia. Anjan Aralihalli continues: "With a comprehensive combination strategy on the horizon, along with plans to initiate clinical trials next year for both mono and combination therapies, we are optimistic about the future prospects of fasudil and our entire pipeline. We are especially grateful to our licensor, University Medical Center Göttingen (UMG), for their pivotal support and collaboration as the principal sponsor of this Phase 2 study. Their commitment and support have been instrumental in advancing fasudil for ALS patients." For more information about Raya and its innovative pipeline, visit or LinkedIn Members of the Raya management team will be attending the ENCALS Annual Meeting in Stockholm, Sweden from June 17-20. About Raya Raya is a mission-driven company focused on the treatment of ALS, leveraging the latest techniques for the selection and development of disease-modifying therapies. The company has a robust pipeline of five distinct clinical stage compounds that each target different pathways involved in motor neuron degeneration seen in ALS patients. The compounds were in-licensed following a rigorous selection process based on biological plausibility, clinical target engagement and functional clinical effects reflective of efficacy. This diversified approach may enable the development of combination therapies which may have a significant impact on disease progression. To develop further combination therapies, Raya entered into a strategic research collaboration with argenx last summer ( ). This partnership explores synergistic effects of their combined drug candidates in the hope of developing more effective treatment options for ALS patients. Raya is further supported by global experts and will leverage a unique patient-friendly platform trial design offering new hope in the fight against ALS. About Fasudil Fasudil is a small molecule inhibitor of the rho-associated kinase (ROCK) and is approved for the treatment of subarachnoid hemorrhage in a few Asian countries. In preclinical studies, fasudil attenuates neurodegeneration, modulates neuroinflammation, and fosters axonal regeneration. About UMG (University Medical Center Göttingen) The UMG located in Göttingen, Lower Saxony, Germany is one of the leading university medical facilities in Germany. It is comprised of a Medical Faculty engaged in research and teaching, a University Hospital providing patient care and Research allowing for the swift transfer of innovative therapy options into patient care and education.

The prevalence of amyotrophic lateral sclerosis has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of amyotrophic lateral sclerosis and the growing research and development activities to develop novel therapies to treat amyotrophic lateral sclerosis to drive the market. The companies developing the potential therapies in the last stage of development include Biogen, AB Sciences, Helixmith, and several others. LAS VEGAS, Feb. 21, 2023 /PRNewswire/ -- DelveInsight's ' Amyotrophic Lateral Sclerosis Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline amyotrophic lateral sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the amyotrophic lateral sclerosis pipeline domain. Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report DelveInsight's amyotrophic lateral sclerosis pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for amyotrophic lateral sclerosis treatment. Key amyotrophic lateral sclerosis companies such as Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others are evaluating new amyotrophic lateral sclerosis drugs to improve the treatment landscape. Promising amyotrophic lateral sclerosis pipeline therapies in various stages of development include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. In February 2023, NeuroSense Therapeutics Ltd. and QuantalX Neuroscience Ltd; the developer of Delphi-MD, a clinically objective neurodiagnostic medical device , announced a collaboration to improve early diagnosis and treatment of neurodegenerative diseases.In addition, the companies agreed that QuantalX's Delphi-MD would be used for early diagnosis and ongoing monitoring of trial participants in NeuroSense's planned future pivotal Phase III efficacy trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS), pending the successful conclusion of its ALS Phase IIb trial. In February 2023, Amylyx Pharmaceuticals, Inc. announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase III clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS. In February 2023, UMass Chan Medical School signed a three-year sponsored research agreement with NeuShen Therapeutics Inc. to investigate a gene therapy treatment for amyotrophic lateral sclerosis, a rare neurological disease. Based in Shanghai and Boston, NeuShen is focused on developing innovative treatments for central nervous system disorders using adeno-associated virus-based gene therapy and small molecule delivery. In January 2023, Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, partnered with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS).The collaboration, led by Jan C. Koch, MD, a principal investigator at the university's Department of Neurology, will be focused particularly on investigating ProcCluster in cellular models of ALS. In January 2023, Amylyx Pharmaceuticals and Neopharm signed a license and distribution agreement to commercialize AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).Neopharm will commercialize the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance.According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercializing the therapy in the covered territory. In January 2023, uniQure N.V. and Apic Bio announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders. Request a sample and discover the recent advances in amyotrophic lateral sclerosis drug treatment @ Amyotrophic Lateral Sclerosis Pipeline Report The amyotrophic lateral sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage amyotrophic lateral sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the amyotrophic lateral sclerosis clinical trial landscape. Amyotrophic Lateral Sclerosis Overview Amyotrophic Lateral Sclerosis (ALS) is a rare neurological disease that affects the nerve cells (neurons) that control voluntary muscle movement (those muscles we choose to move). Voluntary muscles are responsible for movements such as chewing, walking, and talking. The disease is progressive, which means that the symptoms worsen over time. There is currently no cure for ALS and no effective treatment to slow or reverse the disease's progression. Muscle weakness or stiffness are common early ALS symptoms. Individuals gradually lose strength and the ability to speak, eat, move, and even breathe as all voluntary muscles are affected. Most people with ALS die from respiratory failure, usually within 3 to 5 years of the onset of symptoms. However, approximately 10% of people with ALS live for ten years or more. There is no single test that can definitively diagnose ALS. A detailed history of the symptoms observed by a physician during physical examination, as well as a review of the individual's full medical history and a series of tests to rule out other diseases, are used to make the ALS diagnosis. Find out more about drugs for amyotrophic lateral sclerosis @ New Amyotrophic Lateral Sclerosis Drugs A snapshot of the Amyotrophic Lateral Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging amyotrophic lateral sclerosis pipeline therapies @ Amyotrophic Lateral Sclerosis Clinical Trials Amyotrophic Lateral Sclerosis Therapeutics Assessment The amyotrophic lateral sclerosis pipeline report proffers an integral view of amyotrophic lateral sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Amyotrophic Lateral Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: RNA interference, Superoxide dismutase 1 expression inhibitors, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists, Angiogenesis inducing agents, Gene transference, Hepatocyte growth factor expression stimulants, G protein-coupled receptor modulators, HSP90 heat-shock protein modulators, Ion channel modulators, Antioxidants, NAD(P)H dehydrogenase (quinone) modulators, CD40 ligand inhibitors, Complement C1 inhibitors, Cyclo-oxygenase 2 inhibitors, DNA gyrase inhibitors Key Amyotrophic Lateral Sclerosis Companies: Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others. Key Amyotrophic Lateral Sclerosis Pipeline Therapies: BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. Dive deep into rich insights for new drugs for amyotrophic lateral sclerosis treatment; visit @ Amyotrophic Lateral Sclerosis Medications Table of Contents For further information on the amyotrophic lateral sclerosis pipeline therapeutics, reach out @ Amyotrophic Lateral Sclerosis Drug Treatment Related Reports Amyotrophic Lateral Sclerosis Epidemiology Amyotrophic Lateral Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted amyotrophic lateral sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. 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