|Audentes Therapeutics Announces Commencement of LUSTRO, a Clinical Assessment and Phase 1 / 2 Run-in Study of Patients with Crigler-Najjar Syndrome|
"We are pleased to announce the commencement of LUSTRO," stated Dr.
LUSTRO is an international study of approximately 16 to 18 Crigler-Najjar patients one year of age or older. The primary objectives of LUSTRO are to characterize the disease course, natural history, serum bilirubin variability and phototherapy usage of Crigler-Najjar patients. LUSTRO will also assess the burden of disease on Crigler-Najjar patients and caregivers. In addition, LUSTRO has been designed as a run-in study to identify patients for potential enrollment in VALENS, the planned Phase 1 / 2 study of AT342, and is intended to serve as a longitudinal baseline and within-patient control for subjects who enroll in VALENS. As LUSTRO will be conducted at the same sites and using the same assessment tools, LUSTRO will also facilitate certain operational aspects of VALENS.
The Investigational New Drug application (IND) for AT342 is active. Audentes plans to report preliminary data from VALENS in the fourth quarter of 2017.
About AT342 to treat Crigler-Najjar Syndrome
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-commencement-of-lustro-a-clinical-assessment-and-phase-12-run-in-study-of-patients-with-crigler-najjar-syndrome-300415664.html