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 the discontinuation, the company intends to initiate a restructuring plan, focusing on Vamorolone for DMD, lonodelestat for cystic fibrosis and other lung diseases, and its discovery-stage gene therapy approach for congenital muscular dystrophy
- Additionally, Santhera will withdraw the EU’s MAA and end the global development program for Puldysa. Participants who are enrolled in the study will discontinue study medication and complete the study’s follow-up evaluations
Click here to read full press release/ article | Ref: Santhera | Image: Businesswire
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