EGRX - Eagle files for FDA nod to start trial of CAL02 for bacterial pneumonia
- Eagle Pharmaceuticals ( NASDAQ: EGRX ) filed an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) seeking clearance to start a trial of CAL02 for treating severe community-acquired bacterial pneumonia (SCABP).
- The IND filing includes a protocol for a global phase 2 trial of CAL02, when added to standard of care therapy, in patients with SCABP.
- The study plans to enroll ~276 patients with SCABP at 120 sites worldwide and enrollment is expected from start of 2023.
For further details see:
Eagle files for FDA nod to start trial of CAL02 for bacterial pneumonia