A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients With Late Onset Pompe Disease
Status: Not yet recruiting
Phase of Trial: Phase I/II
Latest Information Update: 26 Nov 2019
Price : $35 *
At a glance
- Drugs AT 845 (Primary)
- Indications Glycogen storage disease type II
- Focus Adverse reactions; Pharmacodynamics; Proof of concept
- Acronyms FORTIS
- Sponsors Audentes Therapeutics
- 21 Nov 2019 Status changed from planning to not yet recruiting.
- 07 Nov 2019 According to an Audentes Therapeutics media release, the IND application is under review with the U.S. Food & Drug Administration (FDA). The clinical start-up activities are underway. The company is planning on for initiating a screening study with US trial sites to accelerate patient identification for enrollment into this study.
- 07 Jan 2019 According to an Audentes Therapeutics media release, company is planning to file IND in the third quarter of 2019.