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

Recruiting at 2 trial locations

Overseen By Director of Regulatory Affairs

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: TNF Pharmaceuticals, Inc.

Must not be taking: Anti-inflammatories, Anxiolytics, Cannabis, Opioids

Disqualifiers: Dementia, Diabetes, Cancer, COPD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MYMD-1 to evaluate its effectiveness and safety for individuals with chronic inflammation and muscle weakness or frailty. Chronic inflammation can cause weakness and slowness, and the study aims to determine if MYMD-1 can improve these conditions. Participants will be randomly assigned to receive either MYMD-1 or a placebo (a harmless pill resembling the real treatment) to compare outcomes. Suitable candidates for this trial experience muscle strength and speed issues, such as taking longer to walk short distances, and have specific inflammation markers in their blood. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MYMD-1 is generally safe and well-tolerated, with a good safety record. For example, tests with healthy adults taking MYMD-1 reported no major negative effects, indicating that participants did not experience significant problems from the treatment.

Derived from plants, MYMD-1 has been tested in various doses, yielding positive safety results. While no treatment is completely without risk, current evidence suggests that MYMD-1 is safe for people. This is promising for those considering participation in clinical trials with MYMD-1. It is important to consult a healthcare provider to understand the implications of joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sarcopenia?

MYMD-1 is unique because it targets chronic inflammation and sarcopenia/frailty through a novel mechanism of action not commonly seen in current therapies. While standard treatments like corticosteroids primarily suppress the immune response, MYMD-1 aims to modulate the immune system more precisely, potentially reducing side effects. This treatment uses a proprietary compound designed to target specific inflammatory pathways, which could offer a more targeted and effective approach. Researchers are excited about MYMD-1 because it might provide faster relief with fewer side effects compared to traditional therapies, which is a significant advancement for patients suffering from chronic inflammation and muscle weakening conditions.

What evidence suggests that this trial's treatments could be effective for chronic inflammation associated with sarcopenia/frailty?

Research has shown that MYMD-1, which participants in this trial may receive, may help reduce long-term inflammation by blocking a specific protein called TNF-alpha. In earlier studies, MYMD-1 lowered levels of substances in the blood that indicate inflammation. This suggests MYMD-1 might help control the immune system, which is important for conditions like muscle loss (sarcopenia) and weakness (frailty). The drug addresses inflammation directly, making it a potentially effective treatment for these issues. Previous studies have consistently shown positive results, offering hope for its ability to manage chronic inflammation related to sarcopenia and frailty. ^{1 6 7 8 9}

Who Is on the Research Team?

Leonard Dunn, MD

Principal Investigator

Clinical Research of West Florida

Lon Lynn, DO

Principal Investigator

Clinical Research of West Florida

Jeremy Walston, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MYMD-1
• Placebo

How Is the Trial Designed?

Group I: Cohort 3: MYMD1 900mg Experimental Treatment 1 Intervention

Subjects randomly assigned to the MYMD1 900mg cohort

Group II: Cohort 2: MYMD1 750mg Experimental Treatment 1 Intervention

Subjects randomly assigned to the MYMD1 750 cohort

Group III: Cohort 1: MYMD1 600mg Experimental Treatment 1 Intervention

Subjects randomly assigned to the MYMD1 600mg cohort

Group IV: Cohort 4: MYMD1 1050mg Active Control 1 Intervention

Subjects randomly assigned to the MYMD1 1050mg cohort

Group V: Cohort 3: Placebo 900mg Placebo Group 1 Intervention

Subjects assigned to the 900mg placebo group

Group VI: Cohort 4: Placebo group 1050mg Placebo Group 1 Intervention

Subjects assigned to the 1050mg placebo group

Group VII: Cohort 2: Placebo 750mg Placebo Group 1 Intervention

Subjects assigned to the 750mg placebo group

Group VIII: Cohort 1: Placebo 600mg Placebo Group 1 Intervention

Subjects assigned to the 600mg placebo group

Who Is Running the Clinical Trial?

TNF Pharmaceuticals, Inc.

Lead Sponsor

MyMD Pharmaceuticals, Inc.

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled Phase 2 Trial of Drisapersen for Duchenne Muscular Dystrophy. McDonald, CM., Wong, B., Flanigan, KM., et al.[2022]

Citations

1. tnfpharma.com tnfpharma.com/news/mymd-pharmaceuticals-reports-statistically-significant

MyMD Pharmaceuticals Reports Statistically Significant ... MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and ...

2. tnfpharma.com tnfpharma.com/news/mymd-pharmaceuticals-announces-publication-of-phase-1-data

MyMD Pharmaceuticals Announces Publication of Phase 1 ... MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05283486

NCT05283486 | Evaluation of Efficacy, Tolerability, and ... The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/tnf-initiate-mymd-1-trials/

TNF Pharmaceuticals to initiate MYMD-1 Phase II ... MYMD-1 has shown positive results in regulating the immuno-metabolic system by blocking TNF-alpha activity. ... MYMD-1's reduction of inflammation ...

5. europeanpharmaceuticalreview.com europeanpharmaceuticalreview.com/article/188533/developing-a-first-in-class-small-molecule-drug-for-inflammatory-disease/

Developing a first-in-class drug for inflammatory disease MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. While currently available TNF-alpha ...

6. biospace.com biospace.com/press-releases/tnf-pharmaceuticals-announces-positive-clinical-data-supporting-clinical-trial-expansion

TNF Pharmaceuticals Announces Positive Clinical Data ... “Positive data from this milestone study confirms isomyosamine's historically strong safety ... Isomyosamine (MYMD-1®) is a novel plant alkaloid ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165572819302206

MYMD-1, a novel alkaloid compound, ameliorates ... MYMD-1 is a synthetic plant ... Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects.

8. delta.larvol.com delta.larvol.com/Products/?ProductId=d631254d-5e55-497f-9efd-33fe495f3c3b

isomyosamine (MYMD-1) / TNF Pharmaceuticals, Bascom ... In addition to safety and pharmacology data, the presentation will include information on the anti-inflammatory effects of MYMD-1 in a collagen antibody ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05077865?term=BENZALKONIUM%20AND%20LACTIC%20ACID&rank=1

Single Ascending and Multiple Dose Study to Evaluate ... Approximately 32 healthy adult male and female subjects will be given a single capsule of MYMD1 to determine its safety, tolerability, and pharmacokinetic ...