SMA4

Scholar Rock to Present Apitegromab Clinical Data from the TOPAZ Phase 2 Trial in Patients with Type 2 and 3 Spinal Muscular Atrophy at the 2021 Virtual SMA Research & Clinical Care Meeting

Retrieved on: 
Monday, June 7, 2021

A Phase 3 registrational trial in patients with non-ambulatory Type 2 and Type 3 SMA is anticipated to initiate by the end of 2021.

Key Points: 
  • A Phase 3 registrational trial in patients with non-ambulatory Type 2 and Type 3 SMA is anticipated to initiate by the end of 2021.
  • Apitegromab is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA).
  • Scholar Rock believes that inhibiting myostatin activation with apitegromab may promote a clinically meaningful improvement in motor function in patients with SMA.
  • Spinal muscular atrophy (SMA) is a rare, and often fatal, genetic disorder that typically manifests in young children.

Scholar Rock Announces Positive Proof-of-Concept Data from TOPAZ Phase 2 Trial Interim Analysis of SRK-015 in Patients with Type 2 and Type 3 Spinal Muscular Atrophy

Retrieved on: 
Tuesday, October 27, 2020

At baseline, patients had a mean HFMSE score of 22.7 (range 13-39) out of a total possible score of 66.

Key Points: 
  • At baseline, patients had a mean HFMSE score of 22.7 (range 13-39) out of a total possible score of 66.
  • Scholar Rock will host a conference call and audio webcast to discuss the SRK-015 TOPAZ Phase 2 clinical trial interim data today at 8:00 a.m. Eastern Time.
  • (2) Briefing Document to the Clinical Trial Readiness in Spinal Muscular Atrophy (SMA) SMA Europe, TREAT-NMD and European Medicines Agency meeting.
  • A Phase 2 clinical trial in patients with Type 2 and Type 3 SMA is ongoing.