|Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT342 to Treat Crigler-Najjar Syndrome|
"We are pleased to achieve this important milestone and look forward to working with regulatory authorities and the medical and patient communities to evaluate AT342 for the treatment of this serious, life-threatening disease," stated
In addition to VALENS, Audentes plans to imminently begin LUSTRO, a clinical assessment and run-in study. LUSTRO is designed to enroll 16 to 18 Crigler-Najjar patients greater than one year of age and to characterize their disease course, natural history, bilirubin variability and phototherapy usage. The study is intended to identify patients for potential enrollment in VALENS and to serve as a within-patient control for VALENS.
AT342 has been developed in collaboration with the
Editor's Note: Dr. Wilson reports no direct financial conflict of interest related to Audentes.
About AT342 to treat Crigler-Najjar Syndrome
About VALENS, the Phase 1 / 2 clinical study of AT342
About Audentes Therapeutics, Inc.
For more information regarding Audentes, please visit www.audentestx.com.
Forward Looking Statements
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/audentes-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-at342-to-treat-crigler-najjar-syndrome-300400343.html
Investors + Media