MF-300 for Treatment of Age-Related Sarcopenia

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MF-300 in Subjects With Age-related Sarcopenia

This Phase 2b clinical trial will evaluate whether MF-300 can improve physical function and muscle strength and assess its safety in adults aged 65 years and older with sarcopenia. The study will also evaluate how MF-300 is processed by the body and its effects on measures related to muscle health, quality of life, and physical activity.

Participants will receive MF-300 or placebo once daily for 24 weeks. The study includes an initial open-label part evaluating MF-300 followed by a randomized, placebo-controlled part evaluating two dose levels of MF-300.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia in Elderly
• Intervention / Treatment: Drug: MF-300; Drug: MF-300; Drug: Placebo

Detailed Description

Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults.

This Phase 2b, multicenter study will evaluate the efficacy and safety of MF-300 administered orally once daily (QD) for 24 weeks in subjects aged ≥65 years with age-related sarcopenia. MF-300 is an investigational inhibitor of 15-hydroxyprostaglandin dehydrogenase, an enzyme that degrades prostaglandin E2, a signaling molecule involved in the repair and regeneration of skeletal muscle. This study will consist of 2 parts.

Part A will enroll approximately 25 participants in an open-label evaluation of MF-300 75 mg once daily for 24 weeks. Part A is designed to characterize the efficacy, safety and pharmacokinetics (PK) of MF-300 in the target patient population and to provide additional clinical experience prior to initiation of Part B.

Part B will enroll approximately 200 participants who will be randomized 1:1:1 to receive MF-300 75 mg, MF-300 200 mg, or placebo once daily for 24 weeks. Part B will evaluate the efficacy and safety of the two MF-300 dose levels compared with placebo.

The study will assess multiple aspects of physical function, muscle strength, and Quality of Life (QOL). Assessments will include the 5-times chair stand test (5xCST), 4-meter gait speed, Short Physical Performance Battery (SPPB), handgrip strength, and knee extensor strength. Patient-reported assessments will evaluate physical function, the impact of sarcopenia on quality of life, and participants' overall perception of symptom severity.

Physical activity and functional movement during daily living will also be assessed using a wearable device equipped with digital health technology. Falls will be monitored throughout the study.

Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Epirium Bio Study Director; Phone Number: 858-529-1010; Email: clininquiries@epirium.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must meet all of the following criteria to be eligible for participation in the study:
• 1. Capable of giving signed informed consent that includes agreement to comply with the requirements described in the informed consent form (ICF) and in this protocol.
• 2. Male or non-pregnant, non-lactating female aged ≥65 years old at the time of signing the informed consent.
• 3. Presence of sarcopenia as defined by the Sarcopenia Definitions and Outcomes Consortium (SDOC) at Screening and Baseline
• a. Low grip strength: <35.5 kg for male; <20 kg for female using JAMAR hydraulic handheld isometric dynamometer AND
• b. Slowness: usual gait speed over 4 meters of <0.8 m/s
• 4. Total Short Physical Performance Battery (SPPB) score within the range of 4 - 8 points (inclusive) at Screening and Baseline with a time to complete the 5xCSTof ≥14.0 to ≤40.0 seconds.
• 5. Female subjects must have no childbearing potential.
• 6. Male subjects must be non-fertile, vasectomized (vasectomy performed 4 months or more prior to the first dosing), or truly abstinent of heterosexual intercourse and agree to remain abstinent for duration of study and for 30 days from last administration of Study Drug, or heterosexual partner is not of child bearing potential, or subject is willing to continue using 2 medically acceptable forms of birth control from Day -1 until at least 30 days after the last administration of Study Drug.
• 7. Body mass index (BMI) ≤35.0 kg/m2.

Exclusion Criteria:

• Subjects who meet any of the following criteria will be excluded from participating in the study:
• 1. History of a pelvic or lower limb fracture (e.g., femur, tibia) within the past 6 months with persistent negative impact on lower extremity function or any significant impairment or disease adversely impacting gait. Individuals with hip and/or knee replacement performed >12 months prior to Screening are eligible for enrollment if their activity status has stabilized.
• 2. Presence of distal upper extremity impairment either due to prior recent injury or disease (e.g., tenosynovitis, rheumatoid arthritis).
• 3. Presence of acute immobility post-acute hospital admission.
• 4. Confirmed diagnosis of significant psychiatric disease (e.g., dementia/Alzheimer's disease, schizophrenia, severe depression or bipolar disorder). Individuals with adequately treated depression are eligible for enrollment.
• 5. Neurological injury/disorder with significant persistent functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, multiple sclerosis, polymyositis, dermatomyositis, myopathy/myositides, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy).
• 6. Intraocular surgery and laser procedures for refractive correction within 6 months prior to Screening.
• 7. Known history of glaucoma or evidence suggestive of glaucoma at Screening, including elevated intraocular pressure as measured by tonometry, as determined by the Investigator.
• 8. Vitamin D deficiency defined as 25-OH-vitamin D levels <8.0 ng/mL (20 nmol/L).
• 9. Hemoglobin concentration below 11.0 g/dL (110 g/L) for males or below 10.0 g/dL (100 g/L) for females at Screening.
• 10. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 calculated by central lab using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation.
• 11. History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale.
• 12. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent, acquired immunodeficiency syndrome (AIDS), medically confirmed diagnosis of chronic fatigue syndrome, long COVID, or type 1 diabetes mellitus.
• 13. History of or ongoing gastrointestinal (GI) conditions (e.g., active and chronic colitis, small or large bowel resection, gastric bypass or equivalent) that would interfere with drug tolerance or absorption.
• 14. Abnormal liver function tests such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or serum bilirubin (except Gilbert's Disease) determined based on the following criteria:
• a. Any single transaminase may not exceed 3x the upper limit of normal (ULN). A single parameter elevated up to and including 3x ULN should be re-checked as soon as possible, and always prior to enrollment/randomization, to rule out any lab error.
• b. If the total bilirubin level is above the ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, total bilirubin should not exceed the value of 1.6 mg/dL.
• 15. Platelet count <75,000/mm3.
• 16. Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) or conditions with hepatotoxic potential (e.g., known gallbladder or bile duct disease, acute or chronic pancreatitis).
• 17. Confirmed diagnosis of heart failure classified as New York Heart Association Class III and IV (e.g., dilated cardiomyopathy).
• 18. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g., angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of Screening. Subjects with current/active unstable angina are excluded.
• 19. Severe cardiac valve disorders or defects (e.g., aortic or mitral stenosis).
• 20. Severe pulmonary hypertension uncontrolled with medication.
• 21. Clinically significant cardiac arrhythmia requiring medical intervention in the past 3 months prior to Screening (e.g., supraventricular tachycardia, atrial fibrillation with rapid ventricular rate, automated implantable cardioverter defibrillator with discharge).
• 22. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the screening or assessments.
• 23. Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years except for nonmelanoma skin cancers or cancers with excellent prognosis (e.g., early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix).
• 24. Active systemic infection requiring hospitalization or treatment with intravenous anti-infectives or antibiotics within 4 weeks of Screening or randomization.
• 25. Any chronic active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.), to be confirmed prior to randomization. Subjects receiving chemoprophylaxis for latent tuberculosis infection are eligible for the study.
• 26. Active alcohol/drug abuse, or alcohol/drug treatment <12 months prior to Screening; subjects having successfully completed an alcohol/drug treatment program >12 months prior to Screening with sustained abstinence are eligible.
• 27. Individuals who require routine and regular (e.g., daily) assistance from another person to complete one or more basic activities of daily living (ADL) (e.g., bathing, dressing, toileting, feeding, grooming) regardless of where they reside. Assistance with instrumental ADL (e.g., shopping, meal preparation, housework) is permitted.
• 28. Mini Mental State Examination score <24 at Screening.
• 29. Presence of severe malnutrition determined by Mini Nutritional Assessment®-Short Form (MNA®-SF) score ≤9.
• 30. Poorly controlled blood pressure defined as systolic blood pressure >180 or <80 mmHg or diastolic blood pressure >100 or <40 mmHg at Screening or randomization.
• 31. Uncontrolled type 2 diabetes mellitus (i.e., hemoglobin A1c [HbA1c] >8.5% or frequent hypoglycemia).
• 32. Uncontrolled or insufficiently managed hypothyroidism or hyperthyroidism. Hypothyroid subjects who are not on a stable dose of thyroid hormone replacement therapy or have changed the dose of thyroid hormone replacement therapy within the 6 weeks prior to Screening are not eligible for the study.
• 33. Participation in another investigational drug, biologic, or device study, with less than 30 days or less than 5 half-lives from the last dose of investigational product to randomization, whichever is longer, or any other type of medical research judged to be scientifically or medically incompatible with this study.
• 34. Use of any therapies known to affect muscle mass, including androgens, androgen supplements [including over-the-counter dehydroepiandrosterone (DHEA)], gonadotropin releasing hormone (GnRH) analogues, anti-androgens, anti-estrogens (e.g., tamoxifen), progestins with known androgenic component (e.g., norethindrone acetate, megestrol acetate, high-dose tibolone [2.5 mg]), recombinant human growth hormone, growth hormone receptor antagonists (e.g., pregvisomant), oral selective beta-2 agonists, dronabinol or any nutritional supplement other than protein marketed as a muscle anabolic within 3 months prior to Screening.
• 35. Use of any anabolic steroids (e.g., testosterone) within 3 months prior to Screening.
• 36. Use of glucagon-like peptide-1 (GLP-1) receptor agonist or GLP-1/GIP dual agonist therapy for any indication (e.g., obesity, type 2 diabetes mellitus, or metabolic dysfunction-associated steatohepatitis [MASH]) within the 6 months prior to Screening.
• 37. Systemic corticosteroid use for at least 3 months (in the last year) prior to Screening at a daily dose greater than 10 mg prednisone equivalent.
• 38. Use of non-antibody immunosuppressive therapy (e.g., cyclosporine, methotrexate, tacrolimus, cyclophosphamide) within 3 months of Screening.
• 39. Chronic use of a beta blocker initiated within the 3 months prior to Screening.
• 40. Chronic use (continuous use >7 days) of acetaminophen or cyclooxygenase (COX)-1 and/or COX-2 inhibitors (e.g., aspirin, other nonsteroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen, naproxen, diclofenac, or celecoxib) within the 3 weeks of Day 1 and unable to refrain from chronic use over the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: MF-300 75 mg; 75 mg MF-300 administered orally once daily for 24 weeks in Part A	Drug: MF-300; oral tablet at doses of 75mg; Drug: MF-300; oral tablet at doses of 200 mg
Experimental: Part B: MF-300 75 mg; 75 mg MF-300 administered orally once daily for 24 weeks in Part B	Drug: MF-300; oral tablet at doses of 75mg; Drug: MF-300; oral tablet at doses of 200 mg
Experimental: Part B: MF-300 200 mg; 200 mg MF-300 administered orally once daily for 24 weeks in Part B	Drug: MF-300; oral tablet at doses of 75mg; Drug: MF-300; oral tablet at doses of 200 mg
Placebo Comparator: Part B: Placebo; Matching placebo administered orally once daily for 24 weeks in Part B	Drug: Placebo; matching placebo oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-times chair stand test (5xCST)	Change from baseline in physical performance as measured by the time (seconds [sec]) to complete the 5xCST	Baseline, Week 12, and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB)	Change from baseline in physical performance as measured by the SPPB total score	Baseline, Week 12, and Week 24
Handgrip strength	Change from baseline in muscle strength as measured by handgrip strength test (kg)	Baseline, Week 12, and Week 24
Gait Speed	Change from baseline in mobility as measured by the usual gait speed (meter/sec) over 4 meters	Baseline, Week 12, and Week 24
Patient Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF-8d)	Change from baseline in the PROMIS-PF-8d questionnaire. PROMIS-PF-8d consists of 8 questions assessing subjects' physical functions. A higher score indicates better physical functioning.	Baseline, Week 12, and Week 24
Sarcopenia and Quality of Life (SarQoL)	Change from Baseline in the SarQoL questionnaire. The questionnaire addresses 7 domains of health-related quality of life; Physical and Mental Health, Locomotion, Body Composition, Functionality, ADL, Leisure activities, and Fears, and is scored through a scoring algorithm on 100 points, with higher scores reflecting a better quality of life.	Baseline, Week 12, and Week 24
Patient Global Impression of Change (PGIC)	Change from baseline in the PGIC questionnaire. The PGIC is a single-item, patient-reported measure that evaluates the patient's perception of change in their condition since the start of study treatment. Subjects rate their overall change using a standardized categorical scale.	Baseline, Week 12, and Week 24
Patient Global Impression of Severity (PGIS)	Change from baseline in the PGIS questionnaire. The PGIS is a single-item, patient-reported measure that evaluates the patient's perception of severity in their condition. Subjects rate their overall change using a standardized categorical scale.	Baseline, Week 12, Week 24
Appendicular skeletal muscle index (ASMI)	Change from baseline in the ASMI as measured by dual-energy x-ray absorptiometry (DXA).	Baseline and Week 24
Bone mineral density (BMD)	Change from baseline in the BMD at the total hip, lumbar spine, and forearm as measured by DXA.	Baseline and Week 24
Occurrence of Falls	The number of falls post-baseline	up to Week 24
Physical Activity	Change from baseline in physical activity and functional movement in daily living conditions as monitored by a wearable device equipped with digital health technology (DHT).	Baseline, Week 12, and Week 24
Muscle mass as measured by computed tomography (CT)	Change from baseline in cortical bone thickness as measured by CT in all subjects in Part A and subjects in Part B in the CT substudy only.	Baseline and Week 24
Isometric knee extension peak torque	Change from baseline in the isometric knee extension peak torque (Newton meter [Nm]) (only at select sites with capability)	Baseline, Week 12, and Week 24
Isometric knee extension time to peak torque	Change from baseline in the isometric knee extension time to peak torque (sec) (only at select sites with capability)	Baseline, Week 12, and Week 24
Isometric knee extension rate of torque development	Change from baseline in the isometric knee extension rate of torque development (Nm/sec) (only at select sites with capability)	Baseline, Week 12, and Week 24
Isokinetic knee extension peak torque through range of motion	Change from baseline in the isokinetic knee extension peak torque (Nm) through range of motion at 60 degrees/sec and 180 degrees/sec (only at select sites with capability)	Baseline, Week 12, and Week 24
Isokinetic knee extension average and peak power	Change from baseline in the isokinetic knee extension average and peak power (W) through range of motion at 60 degrees/sec and 180 degrees/sec (only at select sites with capability)	Baseline, Week 12, and Week 24
Safety and Tolerability of MF-300	Proportion of Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation	up to Week 28

Collaborators and Investigators

• Sponsor: Epirium Bio Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Sarcopenia; MF-300
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: MF-300-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No