lunes, 13 de julio de 2020

A new U.S. Covid-19 trial from an Indian drugmaker

The Readout
Damian Garde & Meghana Keshavan

A new U.S. Covid-19 trial from an Indian drugmaker

Biocon, an Indian drug maker, announced Saturday that its drug, itolizumab, was associated with a decrease in mortality among patients hospitalized for Covid-19 in a 30-person study.

Indian regulators granted the medicine an emergency clearance for Covid-19 patients with acute respiratory distress syndrome. Equillium, a company based in La Jolla, Calif., is developing the drug in the U.S., where far more data will be required.

Equillium plans a larger clinical trial, the company told STAT’s Matt Herper. “We think the Biocon study was very encouraging, but we want to move forward with what I would characterize as a very measured approach,” said Bruce Steel, Equillium’s CEO.

“We do believe firmly that, particularly in the face of a global pandemic, this is not the time to take shortcuts on really operating at the highest level of scientific rigor.”

“How certain can you be with a 30-patient study?” said Ivor S. Douglas, chief of pulmonary and critical care at the University of Colorado, Denver, who will lead Equillium’s study. “I think on the other hand, you’ve got some interesting and quite plausible biology with a tantalizing clinical signal.”

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