Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty

• Status: Recruiting
• Trial end date: 2023-06-07
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MyMD Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Aged 65 years or older, at the time of signing the ICF

Type of Participant and Disease Characteristics

2. Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL)

3. Low gait speed ≤ 0.8 m/s

4. Short Physical Performance Battery (SPPB) score ≤8

Weight

5. Body weight ≥35 kg Other

6. Adequate dietary intake

7. Able to complete a 4-meter timed walk

8. Assessment and documentation of sarcopenia-related loss of muscle mass based on Dual-energy X-ray absorptiometry (DXA) -derived appendicular skeletal muscle mass index (ASMI) measurements.

Reproductive Status

9. Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

10. Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP)

Informed Consent

11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

1. Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study

2. Currently tobacco users or those who used tobacco within 30 days of study entry

3. Dementia, encephalopathy or any medical condition impacting cognition

4. Medical conditions that would impact mobility testing or handgrip strength including

5. Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength

6. A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (eg, stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management)

7. Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting)

8. History of cardiac conduction abnormalities, arrhythmias, and/or bradycardia

9. Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening

10. Any underlying muscle disease including active myopathy or muscular dystrophy

11. Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (eg, dilated cardiomyopathy)

12. Type I diabetes or uncontrolled Type 2 diabetes

13. Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min)

14. History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale

15. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent

16. Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis)

17. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (eg, angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening

18. Active cancer (ie, under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (eg, early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix)

19. Any known chronic active infection

20. Use of any anxiolytics, cannabis or opioid medications

21. Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study

22. A score of <23 on the Mini Mental Status Exam

23. Treatment with any prescription or investigational drugs, devices or chemotherapy, or any other therapies for sarcopenia

24. Use of medications with narrow therapeutic ranges within 48 hours of the first dose of study treatment

25. Current use of systemic steroids or use of systemic steroids within 90 days of treatment except for prophylaxis against imaging contrast dye allergy or replacement-dose steroids in the setting of adrenal insufficiency (providing this is ≤10 mg/day prednisone or equivalent; see Appendix 5 for steroid conversion table), or transient exacerbations of other underlying diseases such as chronic obstructive pulmonary disease requiring treatment for <3 weeks

26. Vaccination with live vaccines while on study