40 Participants Needed

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

Recruiting at 2 trial locations
Do
Overseen ByDirector of Regulatory Affairs
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests MYMD1, a drug aimed at reducing inflammation, in older adults with muscle weakness and frailty. The drug works by lowering the chemicals that cause inflammation, potentially improving muscle strength.

Will I have to stop taking my current medications?

The trial requires that you stop taking anti-inflammatory drugs on a daily basis. If you are on a stable antidepressant regimen for at least 3 months and agree not to increase the dose during the trial, you may continue taking it. Other medications, especially those with narrow therapeutic ranges, systemic steroids, and certain other drugs, may also need to be stopped or adjusted.

How does the drug MYMD-1 differ from other treatments for Duchenne muscular dystrophy?

The drug MYMD-1 is unique because it is part of a novel trial design that uses a small-sample, sequential, multiple assignment approach, which increases the efficiency of treatment effect estimates by enriching the placebo arm with external control data and using data from all stages. This method aims to improve the accuracy of drug development in rare diseases like Duchenne muscular dystrophy.12345

Research Team

LD

Leonard Dunn, MD

Principal Investigator

Clinical Research of West Florida

LL

Lon Lynn, DO

Principal Investigator

Clinical Research of West Florida

JW

Jeremy Walston, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

Weight
You are 65 years or older, at the time of signing the ICF.
Elevated biomarkers of inflammation (serum IL-6 level ≥2.
See 6 more

Exclusion Criteria

Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis)
Medical conditions that would impact mobility testing or handgrip strength including 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
Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting)
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive MYMD1 or placebo in a blinded fashion until the end-of-study visit on Day 28

4 weeks
Multiple visits for PK sampling and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Weekly phone calls for 30-day follow-up

Treatment Details

Interventions

  • MYMD-1
  • Placebo
Participant Groups
8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cohort 3: MYMD1 900mgExperimental Treatment1 Intervention
Subjects randomly assigned to the MYMD1 900mg cohort
Group II: Cohort 2: MYMD1 750mgExperimental Treatment1 Intervention
Subjects randomly assigned to the MYMD1 750 cohort
Group III: Cohort 1: MYMD1 600mgExperimental Treatment1 Intervention
Subjects randomly assigned to the MYMD1 600mg cohort
Group IV: Cohort 4: MYMD1 1050mgActive Control1 Intervention
Subjects randomly assigned to the MYMD1 1050mg cohort
Group V: Cohort 3: Placebo 900mgPlacebo Group1 Intervention
Subjects assigned to the 900mg placebo group
Group VI: Cohort 4: Placebo group 1050mgPlacebo Group1 Intervention
Subjects assigned to the 1050mg placebo group
Group VII: Cohort 2: Placebo 750mgPlacebo Group1 Intervention
Subjects assigned to the 750mg placebo group
Group VIII: Cohort 1: Placebo 600mgPlacebo Group1 Intervention
Subjects assigned to the 600mg placebo group

Find a Clinic Near You

Who Is Running the Clinical Trial?

TNF Pharmaceuticals, Inc.

Lead Sponsor

MyMD Pharmaceuticals, Inc.

Lead Sponsor

Trials
3
Recruited
110+

Findings from Research

In a Phase 2 study involving 51 ambulant Duchenne muscular dystrophy (DMD) patients, drisapersen at a dose of 6 mg/kg/week showed a potential benefit in improving the 6-minute walking distance (6MWD) compared to placebo, with a mean difference of 27.1 meters at week 24.
Drisapersen was generally well-tolerated, with the most common side effects being injection site reactions and subclinical proteinuria, indicating a manageable safety profile for this treatment.
Placebo-controlled Phase 2 Trial of Drisapersen for Duchenne Muscular Dystrophy.McDonald, CM., Wong, B., Flanigan, KM., et al.[2022]

References

Dynamic enrichment of Bayesian small-sample, sequential, multiple assignment randomized trial design using natural history data: a case study from Duchenne muscular dystrophy. [2023]
Liquid formulation of pentoxifylline is a poorly tolerated treatment for duchenne dystrophy. [2022]
Placebo-controlled Phase 2 Trial of Drisapersen for Duchenne Muscular Dystrophy. [2022]
Molecular treatments in Duchenne muscular dystrophy. [2021]
Update on Standard Operating Procedures in Preclinical Research for DMD and SMA Report of TREAT-NMD Alliance Workshop, Schiphol Airport, 26 April 2015, The Netherlands. [2021]