Biogen to Initiate P-IIIb ASCEND Study Evaluating Higher Doses of Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy

September 16, 2021 Auto Bot Biogen, Pharma, Spinraza 0

Shots:

  • The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in study period & 1st patients are expected to be enrolled in 2021
  • The study will also evaluate upper limb fine motor function in patients aged ≥13yrs. using Konectom app & neurofilament levels as a biomarker. The therapy demonstrated a sustained efficacy & safety profile
  • Nusinersen has marketed as Spinraza with the US FDA approved dose (12mg) & is being evaluated in an ongoing DEVOTE study

Click here o­ read full press release/ article | Ref: Globe Newswire | Image: Linkedin

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