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MYMD-1

Phase 2

Sarcopenia | Small molecule | Other |TNF Pharmaceuticals, Inc.|Last Updated: Oct 30, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05283486Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/FrailtyPHASE2 COMPLETED 40 — — Feb 1, 2022Jun 7, 2023Oct 30, 20233 United States
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Study Endpoints
Primary Endpoints
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Screening

Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

To evaluate the PK of oral doses of MYMD1 capsules
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]

Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.

To evaluate the PK (urine) of oral doses of MYMD1 capsules
Day 1 (predose)

urine sample collection for presence of parent drug - MYMD1

Secondary Endpoints
Incidence of Treatment-Emergent Adverse Events
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: MYMD1 600mgEXPERIMENTALSubjects randomly assigned to the MYMD1 600mg cohort
Cohort 1: Placebo 600mgPLACEBO_COMPARATORSubjects assigned to the 600mg placebo group
Cohort 2: MYMD1 750mgEXPERIMENTALSubjects randomly assigned to the MYMD1 750 cohort
Cohort 2: Placebo 750mgPLACEBO_COMPARATORSubjects assigned to the 750mg placebo group
Cohort 3: MYMD1 900mgEXPERIMENTALSubjects randomly assigned to the MYMD1 900mg cohort
Cohort 3: Placebo 900mgPLACEBO_COMPARATORSubjects assigned to the 900mg placebo group
Cohort 4: MYMD1 1050mgACTIVE_COMPARATORSubjects randomly assigned to the MYMD1 1050mg cohort
Cohort 4: Placebo group 1050mgPLACEBO_COMPARATORSubjects assigned to the 1050mg placebo group
Interventions
NameTypeDescription
MYMD-1 600MGDRUGCohort 1: 600mg drug
MYMD-1 750mgDRUGCohort 2: 750mg drug
MYMD-1 900mgDRUGCohort 3: 900mg drug
MYMD-1 1050mgDRUGCohort 4: 1050mg drug
placebo 600mgDRUGCohort 1: 600mg placebo
placebo 750mgDRUGCohort 2: 750mg placebo
placebo 900mgDRUGCohort 3: 900mg placebo
placebo 1050mgDRUGCohort 4: 1050mg placebo
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Eligibility Criteria
Age Range65 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 (S...

Countries:United States
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