Monkeypox Is A Different Drug Development Ballgame From COVID-19
Company Shifts Focus To Randomized Trials For EUA
SIGA CEO Dennis Hruby spoke with Scrip about how the company is developing its drug, Tpoxx, to address the monkeypox outbreak.
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Since its emergence in the spring, the monkeypox outbreak has spawned a small but growing pipeline of drugs and vaccines, many of them repurposed smallpox products.
Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.
While the Phase IIb SOLANO trial of ION449 met its primary endpoint, AstraZeneca had set a high bar of 70% LDL cholesterol reduction for competitiveness that the study did not hit.