other material
confidence high
sentiment positive
materiality 0.75
Theriva Biologics DSMC recommends advancing SYN-004 trial to Cohort 3 after positive Cohort 2 safety data
Theriva Biologics, Inc.
- DSMC reviewed safety and PK data from Cohort 2 (19 patients) and recommended study proceed to Cohort 3 using cefepime.
- No SAEs or AEs determined related to study drug; 15 SAEs reported among 10 patients typical for allo-HCT.
- No patient blood samples positive for SYN-004 at any timepoint; piperacillin PK as expected.
- Company pursuing additional funding to enable Cohort 3 conduct; Phase 1b/2a trial remains blinded.