Gilead Sciences, Inc. (NASDAQ: GILD) is contending with an ageing pipeline, but reports of testing for one of the company's antiviral drugs for the Wuhan coronavirus, aka 2019-nCoV, has provided a shot in the arm for the stock.
Testing Yet-To-Be Approved Treatment
Gilead said Friday it's working closely with global health authorities, including the FDA, CDC, China CDC and WHO, and with individual researchers and clinicians to contribute its antiviral expertise and resources to help patients and communities fight 2019-nCoV.
The company has provided remdesivir, an experimental antiviral therapy that has not yet been licensed or approved anywhere globally, for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options, the statement said.
Gilead clarified that this has been done at the behest of treating physicians and with the support of local regulatory agencies, who weighed the risk-benefit profile of providing an experimental drug with no data in 2019-nCoV.
A randomized controlled trial to determine the safety and efficacy of remdesivir in 2019-nCoV, along with the support of health authorities in China is planned.
Remdesivir has shown activity against viral pathogens MERS and SARS in both laboratory and animal testing. The company also highlighted limited clinical data that is available from the emergency use of the drug candidate in treating patients with Ebola virus infection.
Human Trials Begin
Meanwhile, Gilead's remdesivir will be tested by a medical team from Beijing-based China-Japan Friendship Hospital for treating 2019-nCoV, Bloomberg reported, citing a hospital spokeswoman.
A Phase 3 trial enrolling 270 coronavirus patients with mild-to-moderate infection is scheduled to start Monday and will end April 27, a local Chinese publication reported. It's designed as a randomized, double-blind, placebo-controlled, multi-center study.
The Wuhan coronavirus has resulted in casualties of 361 thus far, with infections reaching 17,200. Wuhan, the capital city of the central province of Hubei and the epicenter of the outbreak, is sealed, as authorities scramble to control the contagion.
Gilead's stock was trading higher by 4% to $65.74 per share at time of publication.