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

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

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

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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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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