We have conducted single and multiple ascending dose Phase 1 studies in healthy volunteers with icapamespib. We are addressing with the U.S. Food and Drug Administration (FDA) our IND protocol for study in amyotrophic lateral sclerosis (ALS) and our Phase 2a study in Alzheimer’s disease.
The FDA has also cleared an Investigational New Drug (IND) application for a Phase 1b study of icapamespib in malignant glioma, an Orphan Drug indication.
We are concluding a Phase 1b dose-escalation study of zelavespib in myelofibrosis (MF) patients failing ruxolitinib with plans to initiate a Phase 2 study in accelerated and blast phase disease that would lead to AML. We have obtained Orphan Drug designation for zelavespib in patients with MF.