In an open letter from the company’s chairman and chief executive officer, Daniel O’Day reported that the U.S. Food and Drug Administration (FDA) had given the company approval to begin clinical trials of an inhaled version of the drug.
Currently, the only drug approved for use against COVID-19 is Gilead Sciences’ remdesivir. The antiviral drug is given to patients intravenously via daily infusions at the hospital. In an open letter from the company’s chairman and chief executive officer, Daniel O’Day reported that the U.S. Food and Drug Administration (FDA) had given the company approval to begin clinical trials of an inhaled version of the drug.
The company expects to begin screening healthy volunteers for the Phase I trial this week with plans to begin clinical studies in August. If it works, the drug could be given to patients using a nebulizer, which would allow for easier dosing outside the hospital and potentially in earlier stages of the disease.
“We have already learned a lot about how remdesivir works in a relatively short space of time,” O’Day wrote. “All of us at Gilead are grateful for the strong collaborations that helped to make this possible and to the thousands of patients who have taken part in clinical trials.”
Remdesivir is no silver bullet against COVID-19. In clinical trials to date, the patients receiving remdesivir had a 31% faster time to recovery than the placebo group. Patients in the placebo group had a median 15 days recovery, while patients receiving remdesivir recovered a median 11 days. The survival benefit was not statistically significant, 8% compared to 11.6% for the placebo group, although it is at least suggestive of a survival benefit.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept,” said Anthony S. Fauci, director of NIAID, at the time of the clinical trial announcement. “What it has proven is that a drug can block this virus. This will be the standard of care.”
Shortly after that announcement on April 30, the FDA granted the drug Emergency Use Authorization (EUA). Not long after, on May 13, Gilead inked licensing deals with five generic drugmakers to make the drug available in 127 countries. They are Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences.
Gilead stated that the five companies will manufacture the drug for distribution in “low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries.” The agreements are “royalty-free” until the World Health Organization (WHO) indicates the COVID-19 pandemic has ended or “until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.”
And on June 18, Gilead announced it planned to soon start enrolling an open-label, single-arm Phase II/III clinical trial of remdesivir in about 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents. The trial will be performed at more than 30 locations in the U.S. and Europe.
“From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of COVID-19, in parallel with emerging knowledge about the disease,” said Merdad Parsey, Gilead’s chief medical officer. “While the novel coronavirus appears to disproportionally affect adults—especially the elderly and those with underlying health conditions—concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms.”
O’Day provided an overview of the company’s work on evaluating remdesivir in subsets of COVID-19 patients and different stages of the disease. They are running trials of IV infusions in outpatient settings like infusion centers and nursing homes, and in combinations with other therapies.
“Based on our knowledge of the disease so far, it seems that in the earlier stages of COVID-19, the virus itself is the primary driver of illness,” O’Day wrote. “In the later stages, the body’s inflammatory response may cause some of the most life-threatening aspects of the disease. It is important, therefore, to have tools that can work together to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response. We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients.”
As such, they expect results from trials of remdesivir with a JAK inhibitor, Eli Lilly and Incyte’s Olumiant (baricitinib) and another with remdesivir with Genentech’s Actemra (tocilizumab) an interleukin-6 (IL-6) receptor antagonist. O’Day also mentioned recent studies suggesting that the steroid dexamethasone appears to decrease the inflammatory response to the virus.
The company is continuing to shore up its supply chain and manufacturing capabilities for the drug, and expects to have more than two million treatment courses manufactured by the end of 2020 with “many millions more by 2021.” The company donated its entire existing supplies of the drug through June and has now reporting voluntary licensing agreements with nine generic manufacturers.
O’Day noted, “Our best hope of beating COVID-19 is with a set of tools at our disposal: complementary therapeutics, effective vaccines and widespread testing. Having already seen that science can deliver answers, we can be hopeful of continued progress. Gilead will do all it can to help drive that progress by exploring the full potential of remdesivir.”
