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

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

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

Click here to  to read full press release/ article | Ref: Novartis | Image: BioSpace

Tuba Khan

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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