Merdad Parsey, MD, PhD

Gilead Sciences said it will partner with Chinese health authorities on a randomized, controlled trial designed to assess its antiviral drug candidate remdesivir (GS-5734) as a potential treatment for 2019-nCoV novel coronavirus.

Gilead said in a statement that it has offered remdesivir, a Nuc inhibitor, for use in a “small number” of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options. The company added that it is also expediting “appropriate” laboratory testing of remdesivir against 2019-nCoV samples.

“Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide,” Gilead chief medical officer Merdad Parsey, MD, PhD, stated. “While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope.”

Parsey—who joined Gilead effective November 1—said remdesivir had shown in vitro and in vivo activity in animal models against MERS and SARS, coronaviruses that are structurally similar to 2019-nCoV. He also cited limited clinical data from emergency use of remdesivir in the treatment of patients with Ebola virus infection.

Last year, remdesivir and a second experimental Ebola treatment, the Mapp Biopharmaceutical/LeafBio-partnered monoclonal antibody combination therapy ZMApp, were dropped from the Pamoja Tulinde Maisha (PALM [together save lives]) clinical trial, conducted by researchers led by  Jean-Jacques Muyembe-Tamfum, MD, PhD, at the National Institute of Biomedical Research of the Democratic Republic of Congo and Richard T. Davey Jr., MD, at NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

“These two drugs were much less effective at preventing death” than the other two drugs studied, Ridgeback Biotherapeutics’ mAb114, and Regeneron Pharmaceuticals’ three-antibody cocktail REGN-EB3 (REGN3470-3471-3479), the NIH stated on December 10, citing a review of data from the first 499 of 681 people with confirmed Ebola infection who were enrolled in the trial between November 2018 and August 2019.

“No adverse events” in first U.S. patient

However, remdesivir showed more encouraging results when given as a treatment to the first American confirmed to be infected with 2019-nCoV, according to “First Case of 2019 Novel Coronavirus in the United States,” a case study published Friday in The New England Journal of Medicine.

The case study detailed the treatment of a 35-year-old man who checked into an urgent care clinic in Snohomish County, Washington state, with a 4-day history of cough and subjective fever. The man returned to Washington State on January 15 after traveling to visit family in Wuhan, China—but had not visited the wholesale seafood market or health care facilities or had any sick contacts during his stay in Wuhan.

“Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug in development) was initiated on the evening of day 7, and no adverse events were observed in association with the infusion,” according to the case study, co-authored by members of the Washington State 2019-nCoV Case Investigation Team.

“Although a decision to administer remdesivir for compassionate use was based on the case patient’s worsening clinical status, randomized controlled trials are needed to determine the safety and efficacy of remdesivir and any other investigational agents for treatment of patients with 2019-nCoV infection,” the Investigation Team added.

Gilead said it is partnering with NIAID as well as the FDA, the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (HHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), along with individual researchers and clinicians.

“Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV,” the company added.

GSK partners with CEPI

Gilead was one of two biopharma giants to make announcements in recent days related to 2019-nCoV.

Earlier today, GlaxoSmithKline (GSK) announced that it will collaborate with CEPI, the Coalition for Epidemic Preparedness Innovations, to develop a vaccine for the novel coronavirus. GSK said it will make its established pandemic vaccine adjuvant platform technology available toward a 2019-nCoV vaccine—and emphasized the potential of adjuvant technology for reducing the amount of antigen required per dose.

“Our adjuvant technology has previously been used successfully in the pandemic flu setting. It enables using only small quantities of the vaccine antigen which allows the production of more doses of the vaccine–a crucial advantage in a pandemic,” GSK Vaccines CMO Thomas Breuer said in a joint GSK-CEPI statement.

CEPI has agreed to coordinate engagements between GSK and entities funded by CEPI who wish to test their vaccine platform with GSK’s adjuvant technology to develop effective vaccines against 2019-nCoV.

The first such agreement has been signed between GSK and the University of Queensland, Australia, which entered a partnering agreement with CEPI in January 2019 to develop a “molecular clamp” vaccine platform, intended to enable targeted and rapid vaccine production against multiple viral pathogens.

CEPI said it has extended this funding to work on a 2019-nCoV virus vaccine candidate, and access to the GSK adjuvant technology will now support this early stage research.

“Gaining access to GSK’s world-leading adjuvant technology is a huge step forward in developing a vaccine against the novel coronavirus 2019-nCoV,” CEPI CEO Richard Hatchett, MD, added.

University of Queensland is one of four entities that had already launched novel coronavirus vaccine development collaborations with CEPI. The other three are CureVac; Inovio; and a partnership of Moderna and NIAID.

CEPI has also launched a new call for proposals to rapidly develop and manufacture already proven vaccine technology that can be used against the new coronavirus. The call is rolling and open until February 14 at 1500 CET (9 a.m. ET / 6 a.m. PT).

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