losmapimod (FTX-1821) / Fulcrum Therap 
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 56 Diseases   1 Trial   1 Trial   199 News 


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  • ||||||||||  pirfenidone / Generic mfg.
    Journal:  Pirfenidone Prevents Heart Fibrosis during Chronic Chagas Disease Cardiomyopathy. (Pubmed Central) -  Jul 13, 2024   
    Assays of chronic infection of mice with T. cruzi have shown a reduction in heart collagen by pirfenidone. These results propose a novel approach to fibrosis therapy in CD, with the prospect of repurposing pirfenidone to prevent the onset of ECM accumulation in the hearts of the patients.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Safety and Tolerability of Losmapimod for the Treatment of FSHD (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_2593;    
    Losmapimod was well tolerated and may be a promising new treatment for FSHD; a larger phase 3 study is ongoing. Losmapimod administered up to 15 mg BID in >100 subjects with FSHD1 for up to 96 weeks has been generally well-tolerated; the benefit-risk profile of losmapimod for the treatment of FSHD remains positive and favorable.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap, selenomethionine (SLM) / University of Iowa, Holden Comprehensive Cancer Center
    Review, Journal:  Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD): A Systematic Review. (Pubmed Central) -  Jul 5, 2023   
    Peradventure, more clinical trials are still needed to address this subject. Nevertheless, this review provides a clear and concise update on the treatment for this disease.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Safety and Tolerability of Losmapimod for the Treatment of FSHD (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_1794;    
    No drug-related SAEs, deaths, discontinuations due to AEs, or clinically significant changes in vital signs, clinical laboratory results, or ECG parameters were reported. Conclusions Losmapimod administered up to 15 mg BID in >100 subjects with FSHD1 for up to 76 weeks has been generally well-tolerated; the benefit-risk profile of losmapimod for the treatment of FSHD remains favorable.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Feasibility of Measuring Functional Performance of FSHD Patients Using Wearable Sensors to Quantify Physical Activity (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_1665;    
    Fulcrum is evaluating the safety and efficacy of losmapimod for the treatment of FSHD with selected clinical outcome assessments in the ongoing OLS...Conclusions Measurement of functional performance in FSHD patients using wearable sensors is feasible, reliable, and correlates with multiple clinical outcome assessments, activities of daily living, and mobility. This assessment could provide critical data about disease progression and treatment efficacy in future clinical trials.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Feasibility of measuring functional performance of FSHD patients using wearable sensors to quantify physical activity (Poster area - Ballroom B1-B2) -  Aug 20, 2022 - Abstract #WMS2022WMS_331;    
    Evaluate feasibility to monitor daily activity and assess functional outcomes using wearable sensor devices in an open label study (OLS) of losmapimod in facioscapulohumeral muscular dystrophy (FSHD)...Measurement of functional performance in FSHD patients using wearable sensors is feasible, reliable, and correlates with multiple clinical outcome assessments, activities of daily living and mobility. This assessment could provide critical data about disease progression and treatment efficacy in future clinical trials.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Safety and tolerability of losmapimod for the treatment of FSHD (Poster area - Ballroom B1-B2) -  Aug 20, 2022 - Abstract #WMS2022WMS_318;    
    Losmapimod given as up to 15 mg twice daily in >100 subjects with FSHD1 for up to 76 weeks has been generally well-tolerated, consistent with that previously reported in other patient populations. Therefore, the benefit-risk profile of losmapimod for the treatment of FSHD remains favorable.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    ISS13 Measuring Progression in FSHD: Implications for Clinical Trials (Studio 211+212) -  Jul 17, 2022 - Abstract #ICNMD2022ICNMD_403;    
    RWS demonstrated nominally statistically significant and clinically meaningful benefit to muscle function in ReDUX4, a Phase 2 double blind placebo-controlled trial of losmapimod, a small molecule selective p38 MAP kinase inhibitor being developed by Fulcrum Therapeutics as the first disease modifying therapy for FSHD. Results from ReDUX4 and other clinical trials informed the study design of REACH, the first Phase 3 double blind placebo controlled clinical trial in FSHD.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Journal:  Anti-Oxidative and Anti-Inflammatory Micelles: Break the Dry Eye Vicious Cycle. (Pubmed Central) -  Jun 15, 2022   
    Accordingly, the authors develop micelle-based eye drops (more specifically p38 mitogen-activated protein kinases (MAPK) inhibitor Losmapimod (Los)-loaded and ROS scavenger Tempo (Tem)-conjugated cationic polypeptide micelles, designated as MTem/Los) for safe and efficient DED management...Therapeutically, the dual-functional MTem/Los suppress the inflammatory response, reverse corneal epithelial defect, save goblet cell dysfunction, and recover tear secretion, thus breaking the vicious cycle and alleviating the DED. Moreover, MTem/Los exhibit excellent biocompatibility and tolerability for potential application as a simple and rapid treatment of oxidative stress- and inflammation-induced disorders, including DED.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap, Arbidol (umifenovir) / Pharmstandard, Viramidine (taribavirin) /
    Journal:  Contemporary and emerging pharmacotherapeutic agents for the treatment of Lassa viral haemorrhagic fever disease. (Pubmed Central) -  Jun 4, 2022   
    Current treatments for LF are limited, hence the institution of mitigating measures to prevent infection is of utmost importance and should be prioritized, especially in endemic regions. Heightened searches for other therapeutic options with greater efficacy and lower toxicity are still ongoing, as well as for vaccines as the absence of these classifies the disease as a priority disease of high public health impact.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Review, Journal:  Meeting report: the 2021 FSHD International Research Congress. (Pubmed Central) -  May 7, 2022   
    P2
    Although the etiology of the disease for both FSHD type 1 and type 2 has been attributed to gain-of-toxic function stemming from aberrant DUX4 expression, the exact pathogenic mechanisms involved in muscle wasting have yet to be elucidated [2-4]. The 2021 FSHD International Research Congress, held virtually on June 24-25, convened over 350 researchers and clinicians to share the most recent advances in the understanding of the disease mechanism, discuss the proliferation of interventional strategies and refinement of clinical outcome measures, including results from the ReDUX4 trial, a phase 2b clinical trial of losmapimod in FSHD [NCT04003974].
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Clinical, Journal:  Inhibition of p38 MAP Kinase in Patients with ST-Elevation Myocardial Infarction - Findings from the LATITUDE TIMI 60 Trial. (Pubmed Central) -  Apr 8, 2022   
    P3
    Our collective findings raise the hypothesis that mitigating the inflammatory response may result in different outcomes in patients with STEMI and NSTEMI. While the difference in outcomes is exploratory, these findings do support separate examination of patients with STEMI and NSTEMI and increased emphasis on heart failure in future investigation of modulators of inflammation in MI.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap, BMS-345541 / BMS
    Preclinical, Journal:  Senescence-associated hyper-activation to inflammatory stimuli in vitro. (Pubmed Central) -  Jan 12, 2022   
    This senescence-associated hyper-activation is likely mediated in part via the p38MAPK (p38) and NFκB pathways because LPS stimulation elicited significantly higher levels of p38 phosphorylation and NFκB p65 nuclear translation in SnCs when compared to their non-senescent counterparts and inhibition of these pathways with losmapimod (a p38 specific inhibitor) and BMS-345541 (a selective NFκB inhibitor) attenuated LPS-induced expression of IL6, TNFα, CCL5, and IL1β mRNA in SnCs. These findings suggest that SnCs may play an important role in the age-related increases in the susceptibility to developing an exacerbated inflammatory response and highlight the potential to use senotherapeutics to ameliorate the severity of various devastating inflammatory conditions in the elderly.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
    Review, Journal:  The role and transformative potential of IL-19 in atherosclerosis. (Pubmed Central) -  Dec 16, 2021   
    Several other drugs have also been investigated in clinical trials as anti-inflammatory agents; the development of some of these agents has been terminated (canakinumab, darapladib, varespladib, losmapimod, atreleuton, setileuton, PF-04191834, veliflapon, and methotrexate), but others remain in development (ziltivekimab, tocilizumab, Somalix, IFM-2427, anakinra, mesenchymal stem cells (MSCs), colchicine, everolimus, allopurinol, and montelukast)...We propose that IL-19 is a promising biomarker and target for the diagnosis and treatment of atherosclerosis. This review considers the role and mechanism of action of IL-19 in atherosclerosis and discusses whether IL-19 is a potential therapeutic target for this condition.
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Trial completion:  Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets (clinicaltrials.gov) -  Nov 11, 2021   
    P1,  N=18, Completed, 
    This review considers the role and mechanism of action of IL-19 in atherosclerosis and discusses whether IL-19 is a potential therapeutic target for this condition. Recruiting --> Completed
  • ||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  LOSVID: Losmapimod Safety and Efficacy in COVID-19 (clinicaltrials.gov) -  Aug 18, 2021   
    P3,  N=52, Terminated, 
    Future studies examining the proper timing and targetable anti-inflammatory pathways are warranted. N=410 --> 52 | Trial completion date: Jul 2021 --> Mar 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2021 --> Mar 2021; Study terminated due to the rapidly evolving environment for the treatment of Covid-19 and ongoing challenges to identify and enroll qualified patients to participate.