Edgewise Therapeutics, Inc. — Biomedical Watch V2

Traitements14programmes

Essais4liés

Publications3liées

SourceDBlocale

Traitements

14

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
EDG-5506 TabletThis is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.	Myopathies	Phase 1	À vérifier	United States	À vérifier
Radiolabeled EDG-5506 IntravenousThis is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.	Myopathies	Phase 1	À vérifier	United States	À vérifier
Radiolabeled EDG-5506 SuspensionThis is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.	Myopathies	Phase 1	À vérifier	United States	À vérifier
SevasemtenEDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy	Myopathies	Phase 2	À vérifier	United States, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, …	À vérifier
Sevasemten 10 mgA study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.	Myopathies	Phase 2	À vérifier	United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy, …	À vérifier
Sevasemten 12.5 mgA study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.	Myopathies	Phase 2	À vérifier	United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy, …	À vérifier
Sevasemten 5 mgA study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.	Myopathies	Phase 2	À vérifier	United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy, …	À vérifier
Sevasemten Dose 1The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.	Myopathies	Phase 2	Thérapie génique	United States	À vérifier
Sevasemten Dose 2The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.	Myopathies	Phase 2	Thérapie génique	United States	À vérifier
Sevasemten Dose 3The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.	Myopathies	Phase 2	Thérapie génique	United States	À vérifier
EDG-5506 TabletThis is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.	Myopathies	Phase 1	À vérifier	United States	À vérifier
Sevasemten Dose 1The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.	Myopathies	Phase 2	Thérapie génique	United States	À vérifier
SevasemtenEDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy	Myopathies	Phase 2	À vérifier	United States, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom	À vérifier
Sevasemten 10 mgA study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.	Myopathies	Phase 2	À vérifier	United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, New Zealand, Spain, United Kingdom	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Sevasemten 10 mg	Myopathies	Phase 2	NCT05291091	Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)	ACTIVE_NOT_RECRUITING
Sevasemten	Myopathies	Phase 2	NCT06066580	MESA — Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy	ENROLLING_BY_INVITATION
Sevasemten Dose 1	Myopathies	Phase 2	NCT06100887	FOX — Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy	ACTIVE_NOT_RECRUITING
EDG-5506 Tablet	Myopathies	Phase 1	NCT05730842	Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers	COMPLETED

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Sevasemten Dose 2		A Phase 1, Double-Blind, Placebo-Controlled Trial of Sevasemten (EDG-5506), a Selective Modulator of Fast Skeletal Muscle Contraction, in Healthy Volunteers and Adults With Becker Muscular Dystrophy.	Muscle & nerve
Sevasemten Dose 1		Effects of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults with Becker muscular dystrophy: results of a phase 1b, open-label study.	EBioMedicine
Sevasemten Dose 1		Human Disposition, Metabolism, and Excretion of Sevasemten (EDG-5506), a Selective Modulator of Fast Myosin in Healthy Volunteers.	Journal of clinical pharmacology