ML Bio Solutions, Inc. — Biomedical Watch V2

Traitements5programmes

Essais3liés

Publications0liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
BBP-418BBP-418 is being developed for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I). This is an open label study to determine the safety and tolerability of ascending dose levels of BBP-418 in the treatment of ambulatory and non-ambulatory patients with LGMD2I for which no approved therapy currently exists.	Myopathies	Phase 2	À vérifier	United States	À vérifier
BBP-418 (ribitol)This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9. Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.	Myopathies	Phase 3	À vérifier	United States, Australia, Denmark, Germany, Italy, Netherlands, Norway, United Kingdom	À vérifier
BBP-418BBP-418 is being developed for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I). This is an open label study to determine the safety and tolerability of ascending dose levels of BBP-418 in the treatment of ambulatory and non-ambulatory patients with LGMD2I for which no approved therapy currently exists.	Myopathies	Phase 2	À vérifier	United States	À vérifier
BBP-418 (ribitol)This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9. Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.	Myopathies	Phase 3	À vérifier	United States, Australia, Denmark, Germany, Italy, Netherlands, Norway, United Kingdom	À vérifier
BBP-418 (ribitol)This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify). Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9. Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.	Myopathies	Phase 3	À vérifier	United States, Australia, Denmark, Germany, Italy, Netherlands, Norway, United Kingdom	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
BBP-418 (ribitol)	Myopathies	Phase 3	NCT05775848	Fortify — Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)	ACTIVE_NOT_RECRUITING
BBP-418 (ribitol)	Myopathies	Phase 3	NCT07678775	Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9	ACTIVE_NOT_RECRUITING
BBP-418	Myopathies	Phase 2	NCT04800874	Study of BBP-418 in Patients With LGMD2I	ACTIVE_NOT_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.