FDA Grants Fast Track Designation to SBT101, the First Investigational AAV-Based Gene Therapy for Patients with Adrenomyeloneuropathy (AMN)

“AMN is an adult-onset progressive, degenerative spinal cord disease caused by mutations in the ABCD1 gene leading to loss of mobility, incontinence, and pain. SwanBio plans to initiate a randomized, placebo-controlled Phase 1/2 clinical trial designed to assess the safety and explore the efficacy of SBT101 in patients with AMN in the second half of 2022. The clinical program for SBT101 builds on SwanBio’s unique understanding of AMN, including new insights being gathered in the company’s ongoing natural history study, CYGNET.”

 

 

To read the rest of the press release: https://swanbiotx.com/investors-and-media/fda-grants-fast-track-designation-to-sbt101-the-first-investigational-aav-based-gene-therapy-for-patients-with-adrenomyeloneuropathy-amn/ 

 

 

Swanbio Therapeutics AMN Gene Therapy Update

FDA Grants Fast Track Designation to SBT101, the First Investigational AAV-Based Gene Therapy for Patients with Adrenomyeloneuropathy (AMN)