Gilead gets green light for inhaled remdesivir study

By Jenni Spinner

- Last updated on GMT

(Panorama Images/iStock via Getty Images Plus)
(Panorama Images/iStock via Getty Images Plus)

Related tags Gilead COVID-19 inhalation products Coronavirus Fda

After receiving FDA approval, the pharmaceutical company has announced plans to launch a Phase I trial for an inhaled version of the COVID-19 treatment.

On Monday June 22, Gilead Sciences announced it is preparing to kick off a trial testing an inhalable version of the investigational COVID-19 drug remdesivir. Via an open letter penned by chairman and CEO Daniel O’Day, the company reported it is about to screening healthy volunteers this week, in the hopes of starting a trial in August.

Remdesivir is an antiviral drug that has been approved to treat COVID-19 patients. To date, the treatment has been administered intravenously; the company hopes delivering the drug via a nebulizer could allow for easier dosing outside hospitals to patients in the earlier stages, helping to stem the progress of the disease.

Showing promise

In the letter, O’Day pointed at previous studies showing remdesivir’s potential in treating COVID-19 patients. A National Institute of Allergy and Infectious Diseases (NIAID)​ randomized, controlled trial reportedly showed the drug shortened recovery time by an average of four days, and Gilead’s SIMPLE study of moderate patients showed better clinical outcomes with a five-day remdesivir course than those receiving standard of care.

O’day also pointed out the NIAID study indicated treatment worked best in patients who did not yet need ventilation, indicating further study in patients in the early stages of the disease was warranted.

“The totality of these data shows that remdesivir has the potential to be of meaningful benefit to patients with COVID-19 and offers important hope,​” O’Day wrote. “In our ongoing studies, we will work to deliver on that hope and potentially benefit more patients​.”

In addition to the inhaled trial, Gilead plans to investigate remdesivir in a number of other early-intervention trials, according to O’Day:

  • Intravenous infusions delivered to COVID-19 patients in outpatient settings, such as clinics and nursing homes.
  • Combining with anti-inflammatory agents
  • In conjunction with immune modulators
  • With vulnerable patient populations, including children and pregnant women.

On the rise

In the race to uncover viable treatment options for COVID-19, remdesivir appears to be on the rise in the estimation of agencies like the US Food and Drug Administration (FDA), and pharmaceutical companies. In May, Gilead partnered with Mumbai-based company Cipla​ to scale up manufacturing of the active pharmaceutical ingredient (API) and product on a commercial scale.

However, hydroxychloroquine—the drug touted by President Donald Trump as an option for treating the virus—is falling out of favor. Pharmaceutical companies like Novartis, the National Institutes of Health (NIH), and the World Health Organization (WHO) all recently withdrew support for hydroxychloroquine​ and halted studies; reasons included evidence that the drug was “unlikely to be effective” and low participant enrollment.

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