Novartis Lifts Partial Clinical Trial Hold on OAV-101 Clinical Program to Treat SMA

Shots:

• The FDA decision to lift the partial clinical trial hold of the OAV-101 IT clinical program is based on data from a nonclinical toxicology study in NHP
• The company plans to start P-III STEER study to evaluate the efficacy & safety of OAV-101 IT vs sham controls in treatment naïve patients aged b/w 2-18yrs. with SMA Type 2. The study is based on the P-I/II STRONG study that demonstrated an increase in HFMSE scores and clinical response in patients aged b/w ≥2 & <5yrs. with SMA Type 2
• OAV-101 IT is currently under investigation as a monothx. for one time treatment option to treat older patients with SMA

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