What's The Plan?

Xenthera received the Approval to Proceed letter from the Agency in Aug 2022.  

The current Phase I trial is a dose escalation study with the primary objective to find the recommended Phase II dose. Up to 5 dose levels will be assessed using a once-a-day oral tablet.  

Startup packets are ready to send to the site upon receipt of seed funds.  

First Patient Enrolled (Est) - Q2 2023   First Safety Date Review (Est) - Q3 2023

Design and submit application for XT-0528 in Phase Ib/IIa to support efficacy, estimated Q4 2023. Consider expansion cohorts. 

Currently evaluating additional molecules for development.