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Despite associations with falls, hospitalization, and all-cause mortality, no approved pharmacologic therapy exists, creating an unmet need. MF-300, an investigational first-in-class oral 15-hydroxyprostaglandin dehydrogenase inhibitor, was assessed for safety, tolerability, PK/PD, and biomarker target engagement in healthy adults.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/phase-1-evaluation-of-mf-300-an-investigational-first-in-class-oral-candidate-for-sarcopenia/426461/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/phase-1-evaluation-of-mf-300-an-investigational-first-in-class-oral-candidate-for-sarcopenia/426461.png","ImageObject",300,407,{"name":92,"@type":93},"Kurz","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-19","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":34},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What condition is MF-300 being developed to treat?","Question",{"text":112,"@type":113},"MF-300 is being developed for age-related sarcopenia, a progressive loss of skeletal muscle mass and function.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was MF-300 evaluated in Phase 1?",{"text":117,"@type":113},"Safety, tolerability, pharmacokinetics, and pharmacodynamics were assessed in healthy adults in a Phase 1 double-blind Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the key safety and PK/PD outcomes?",{"text":121,"@type":113},"MF-300 was safe and well-tolerated, with no serious adverse events. It showed rapid absorption and a half-life supporting once-daily dosing, while exposure and PD biomarker changes supported target engagement.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},426461,1790921741,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":34,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":8,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":81},2336478945635,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Innovation in Aging, 2025, Vol. 9, No. S2 1193  \nAbstract citation ID: igaf122.3994  \nPHASE 1 EVALUATION OF MF-300: AN  \nINVESTIGATIONAL FIRST-IN-CLASS ORAL  \nCANDIDATE FOR SARCOPENIA  \nLeigh MacConell1, Amrik Shah2, Diane Mould3, Siva Lavu4, and Micah Webster5, 1. Alchemeos Clinical Consulting, Encinitas, California, United States, 2. Karma Statistics LLC, Skillman, New Jersey, United States, 3. Projections Research Inc, Phoenixville, Pennsylvania, United States, 4. RedOwlet LLC, Wellesley, Massachusetts, United States, 5. Epirium Bio, San Diego, California, United States  \nAge-related sarcopenia, a progressive chronic disease involving loss of skeletal muscle mass and function, contributes to disability and loss of independence, affecting 1/3 of Americans over 60 years. Despite being associated with increased risk of falls, hospitalization, and all-cause mortality, no pharmacologic treatment is approved for sarcopenia, representing an important unmet medical need. MF-300 is an investigational, first-in-class, orally administered, 15-hydroxyprostaglandin dehydrogenase inhibitor that improves aged muscle force in preclinical studies and is in development for sarcopenia. Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MF-300 were evaluated in healthy adults in a Phase 1 double-blind Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study. In the SAD, MF-300 or placebo were administered to 40 subjects at 5 doses (75mg to 800mg). In theMAD, dose escalation included QD doses of 75mg, 125mg, and 200mg for 5 days to 30 subjects. Urinary prostaglandin E2 and its metabolites were investigated as MF-300 target engagement biomarkers. All participants completed the study. MF-300 was observed to be safe and well-tolerated; all but one adverse event was mild with no dose relationship. There were no serious adverse events. The PK profile showed rapid absorption (Tmax 1.17h-2.58h) and a T1/2 supporting QD dosing (12.2h-15.9h). Exposure metrics (Cmax, AUC) increased slightly greater than dose-proportionally and were consistent with anticipated therapeutic activity based on preclinical data. Dose-related changes in PD biomarkers were consistent with MF-300 target engagement. These findings support further Phase 2 evaluation of MF-300 in age-related sarcopenia.","cbCaisT7CxeONMLS","https://ap.wps.com/l/cbCaisT7CxeONMLS","pdf",1047895,"English","# Background and Unmet Need\n## MF-300 and Study Design (SAD/MAD)\n## Safety, PK/PD, and Biomarker Findings\n## Conclusion and Next Steps","[{\"question\":\"What condition is MF-300 being developed to treat?\",\"answer\":\"MF-300 is being developed for age-related sarcopenia, a progressive loss of skeletal muscle mass and function.\"},{\"question\":\"How was MF-300 evaluated in Phase 1?\",\"answer\":\"Safety, tolerability, pharmacokinetics, and pharmacodynamics were assessed in healthy adults in a Phase 1 double-blind Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study.\"},{\"question\":\"What were the key safety and PK/PD outcomes?\",\"answer\":\"MF-300 was safe and well-tolerated, with no serious adverse events. It showed rapid absorption and a half-life supporting once-daily dosing, while exposure and PD biomarker changes supported target engagement.\"}]","PHASE 1 EVALUATION OF MF-300: AN INVESTIGATIONAL FIRST-IN-CLASS ORAL CANDIDATE FOR SARCOPENIA | PDF",1790640660]