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EDG-5506

Phase 1

Healthy Volunteer | Small molecule | Rare Disease |Edgewise Therapeutics, Inc.|Last Updated: Apr 18, 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-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment142
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05730842Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy VolunteersPHASE1 COMPLETED 15 — — Jan 12, 2023Apr 6, 2023Apr 18, 20231 United States
NCT04585464A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy AdultsPHASE1 COMPLETED 127 — — Oct 12, 2020Dec 27, 2021Jun 28, 20221 United States
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Study Endpoints
Primary Endpoints
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
Up to 37 days
The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces
Up to 37 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
Up to 37 days
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
Up to 37 days
Absolute bioavailability of EDG-5506 as measured by Fabs
Up to 9 days
Incidence, frequency, severity and dose-relationship of adverse events
Up to 42 days of monitoring
Incidence of abnormal laboratory test results (clinical chemistry, hematology, urinalysis, coagulation)
Up to 42 days of monitoring
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
Up to 42 days of monitoring
Incidence of abnormal vital signs
Up to 42 days of monitoring
Incidence of abnormal physical exam findings
Up to 42 days of monitoring
Secondary Endpoints
Incidence of treatment-emergent adverse events
Up to 37 days
Incidence of abnormal clinical laboratory test results
Up to 37 days
Incidence of abnormal electrocardiograms (ECGs)
Up to 37 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A - AMEEXPERIMENTALEvaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers
Part B - aBAEXPERIMENTALEvaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers
Healthy Volunteer: Single Ascending DoseEXPERIMENTALSingle oral ascending dose in healthy volunteers Interventions: Drug: EDG-5506 Drug: Placebo
Healthy Volunteer: Multiple Ascending DoseEXPERIMENTALMultiple oral ascending doses in healthy volunteers Interventions: Drug: EDG-5506 Drug: Placebo
Becker Muscular Dystrophy: Multiple Ascending DoseEXPERIMENTALMultiple oral ascending doses in adults with Becker muscular dystrophy Interventions: Drug: EDG-5506 Drug: Placebo
Interventions
NameTypeDescription
EDG-5506 TabletDRUGSingle Oral Dose - Tablet
Radiolabeled EDG-5506 SuspensionDRUGSingle Oral Dose
Radiolabeled EDG-5506 IntravenousDRUGSingle Intravenous Dose
EDG-5506DRUGEDG-5506 is administered orally as a single dose or once daily
PlaceboDRUGPlacebo is administered orally as a single dose or once daily
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive. 2. For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg. 3. In good health, determined by no clin...

Countries:United States
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