PhaseBio Cleared by FDA for Trial of Virus Treatment

PhaseBio was cleared by the FDA to conduct a clinical trial to assess a drug candidate to treat covid-19.
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PhaseBio Pharmaceuticals PHAS shares jumped after the Food and Drug Administration cleared the biopharma to conduct a clinical trial of a candidate drug to treat covid-19.

At last check PhaseBio shares were up by more than a third at $5.93. They've traded on Thursday as high as $6.50, up 47%.

The Malvern, Pa., company said its Vangard trial of the drug, PB1046, was approved under the FDA's Coronavirus Treatment Acceleration Program. 

The Vangard trial will assess the safety and efficacy of the drug "as a treatment for hospitalized covid-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome," the company said.

The study will enroll 210 patients at some 20 sites across the country. The test's primary endpoint will be how many days patients are alive and free of respiratory failure. 

"We decided to pursue a rigorous, double-blind randomized trial to evaluate PB1046 as a treatment for covid-19 patients at high risk of progressing to acute respiratory distress syndrome," Chief Executive Jonathan Mow said in a statement. 

"PhaseBio moved very rapidly to develop a study protocol and submit an investigational new drug application to the FDA."

Having received FDA clearance, PhaseBio expects to begin dosing patients for the trial by the end of June, with results expected late in the fourth quarter. 

"Physicians are in desperate need of new options to treat covid-19 patients facing rapid deterioration of lung function and before progressing to a ventilator," said John Lee, a physician and chief medical officer at PhaseBio.

Lee said the prognosis for patients who ultimately require ventilator support is very poor, so "the importance of new treatment options that could help reduce this burden cannot be overstated."