FDA Grants RMAT Designation to Cyllene Therapeutics' EG110A for Neurogenic Detrusor Overactivity
核心洞察
Cyllene Therapeutics (搜索) received FDA Regenerative Medicine Advanced Therapy designation for EG110A in neurogenic detrusor overactivity (搜索) with urinary incontinence (搜索).
EG110A is a non-replicating HSV-1 vector designed to selectively silence CGRP+ sensory neurons while preserving normal bladder function.
The designation follows positive interim Phase 1b/2a results in spinal cord injury patients, with full interim data due at ICS in October 2026.
Cyllene Therapeutics (搜索) announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to EG110A, its lead candidate for neurogenic detrusor overactivity (搜索) (NDO) with urinary incontinence (搜索). EG110A is a non-replicating HSV-1 vector designed to selectively silence CGRP+ (type C) sensory neurons responsible for bladder muscle overactivity while preserving normal bladder function. It is described as the first non-systemic, site-specific inhibitor of CGRP+ neurons, and the first product from the company's HERMES platform.
The designation was granted based on initial positive results from an ongoing Phase 1b/2a trial in patients with NDO associated with spinal cord injury, where the company reports strong, lasting efficacy and a good safety profile. Interim results will be presented at the International Continence Society annual conference on October 7, 2026, in Maastricht. Cyllene said the clinical data seen to date show a marked reduction in urinary episodes, and that a single treatment course could potentially provide long-lasting symptomatic relief.
The company plans to move further into clinical development with a Phase 2b/3 study of EG110A in neurogenic detrusor overactivity (搜索) in 2027.