Tags : Idebenone

Santhera Halts P-III SIDEROS Study Evaluating Puldysa in Patients with

Shot:     Santhera has discontinued the development of Puldysa (idebenone) in patients with DMD who are in respiratory decline and receive concomitant glucocorticoid treatment. The DSMB has recommended the discontinuation of the SIDEROS study due to futility as it fails to meet its 1EPs i.e. the change of FVC%p from baseline to 18mos. of treatment Following […]Read More

Santhera Reports Results of Idebenone in SYROS Study for Duchenne

Shots: The SYROS study involves assessing of respiratory function evolution during periods of treatment with idebenone (900 mg/day) (On-Idebenone) compared to period without idebenone treatment (Off-Idebenone) in 18 patients with DMD not using glucocorticoids under Expanded Access Programs following P-III DELOS study, published in Neuromuscular Disorders The SYROS study results demonstrated long-term efficacy in slowing […]Read More

Santhera Reports Results of Raxone (Idebenone) in P-III DELOS trial

Shots: The P-III DELOS trial involves assessing of idebenone (900mg/day) vs PBO in 64 patients with DML for 52 wks. P-III DELOS study results: 50% reduction in annual rates of forced vital capacity; treatment effect remained 6 yrs.; reduction in risk of important patient-relevant outcomes including bronchopulmonary AEs and hospitalizations; reductions in the rate of […]Read More