A Phase I/IIa, Double-Blind, Placebo-Controlled Study Validating the Safety, Pharmacokinetics and Pharmacodynamic Profile of Sarconeos in Paediatric Patients with Duchenne Myopathy (MYODA-PK)
Phase of Trial: Phase I/II
Latest Information Update: 22 Oct 2018
At a glance
- Drugs Sarconeos (Primary)
- Indications Duchenne muscular dystrophy
- Focus Pharmacokinetics
- Acronyms MYODA-PK
- Sponsors Biophytis
- 22 Oct 2018 According to a Biophytis media release, The company has requested scientific advice from the FDA and EMA regarding the clinical program, and expects to obtain regulatory approvals for the MYODA-PK study of safety and pharmacokinetics in patients in S1 2019.
- 13 Sep 2018 According to a Biophytis media release, MYODA clinical program in Duchenne myopathy, is expected to be authorized by the FDA before the end of 2018.
- 28 Mar 2018 According to a Biophytis media release, this study could be launched in the second half of 2018.