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ARTICLE | Clinical News

AM-Pharma's Phase II sepsis readout triggers Pfizer's takeout option

March 16, 2018 4:34 PM UTC

AM-Pharma B.V. (Bunnik, the Netherlands) reported mixed data from the Phase II STOP-AKI trial of recAP to treat sepsis-associated acute kidney injury (AKI). The readout marks the start of an option period under which Pfizer Inc. (NYSE:PFE) may buy out AM-Pharma.

On the 301-patient trial's primary endpoint, once-daily IV recAP for three days failed to significantly improved kidney function as measured by the area under the time-corrected endogenous creatinine clearance curve over the first seven days vs. placebo. AM-Pharma said recAP did show a significant and sustained improvement in renal function over the 28-day duration of the trial vs. placebo. Additionally, recAP significantly reduced mortality by more than 40% compared with placebo. Secondary endpoints in the double-blind, international trial include the incidence of renal replacement therapy (RRT) over 28 days, immunogenicity and quality of life (QOL)...

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