The first patient has been dosed in a 1,500-subject Phase 2 platform study, I-SPY COVID, evaluating repurposed and investigational drugs in critically ill COVID-19 patients.
The trial will assess Gilead Sciences’ (NASDAQ:GILD) Veklury (remdesivir), AbbVie’s (NYSE:ABBV) cenicriviroc, Takeda’s (NYSE:TAK) Firazyr (icatibant), Amgen’s (NASDAQ:AMGN) Otezla (apremilast) and Aerpio Pharmaceuticals’ (NASDAQ:ARPO) razuprotafib.
The least familiar may be razuprotafib (AKB-9778) which inhibits an enzyme called vascular endothelial protein tyrosine phosphatase (VE-PTP) that down-regulates a protein called Tie2. Decreased Tie2 activity is associated with vascular instability in many diseases so inhibiting VE-PTP helps maintain a high activity level of Tie2.
All participants will start with high-flow oxygen via nasal prongs or mask and will be asked to sign a consent form for the backbone therapy and a specific investigational arm to which they are assigned.
The primary endpoint will be the time to recover to a durable level 4 (or less) on the WHO ordinal scale for clinical improvement. Level 4 patients are those with mild disease, hospitalized and needing supplemental oxygen. Level 0 are patients who have recovered, showing no clinical or virological signs of infection.
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