Gilead Sciences Initiates Clinical Trial of Inhaled Remdesivir for Early-Stage COVID-19 Treatment

Gilead Sciences Initiates Clinical Trial of Inhaled Remdesivir to Explore Efficacy in Early-Stage Disease

Today, the CEO of Gilead Sciences announced in an open letter that the company has received approval from the U.S. FDA to begin clinical trials of an inhaled formulation of remdesivir. The company will start screening healthy volunteers this week, with the aim of initiating clinical studies in COVID-19 patients by August. Remdesivir is currently administered via daily intravenous infusion for hospitalized patients, whereas the inhaled formulation will be delivered via a nebulizer. This could facilitate its use outside of hospital settings during the early stages of the disease, which is significant for helping to curb the pandemic.

In addition, Gilead Sciences’ next wave of research on remdesivir will include further exploration of treating COVID-19 in the early stages of the disease. For instance, Gilead Sciences will conduct studies on the use of intravenous infusion in outpatient settings, which is particularly beneficial for patients at high risk of disease progression to initiate treatment outside of hospitals. Early intervention may help patients avoid hospitalization. In the coming months, results from trials evaluating remdesivir in combination with the JAK inhibitor baricitinib and the IL-6 receptor antagonist tocilizumab are expected to be reported. Gilead Sciences will also explore the efficacy of remdesivir in a range of high-risk patient populations, including children, pregnant women, and patients with end-stage renal disease, among others.

In an open letter, Daniel O’Day, CEO of Gilead Sciences, stated that our greatest hope for defeating COVID-19 lies in the array of tools at our disposal: complementary therapies, effective vaccines, and widespread testing. Gilead Sciences will do everything in its power to advance this effort by unlocking the full potential of remdesivir.

Oral Remdesivir-like Antiviral Therapy Initiates Phase 2 Clinical Trial

Ridgeback Biotherapeutics Announces Initiation of Two Phase 2 Clinical Trials to Evaluate the Efficacy of Investigational Therapy EIDD-2801 in Patients with COVID-19. Phase 1 clinical trial results demonstrated that EIDD-2801 exhibited a favorable safety profile and achieved blood concentrations in patients exceeding the levels required for effective antiviral activity in animal models.

EIDD-2801 is an investigational, orally administered potent nucleoside analog that inhibits the replication of various mRNA viruses, including SARS-CoV-2, the coronavirus responsible for COVID-19. In animal studies, it has been shown to improve lung function and reduce viral loads in lung tissue. Notably, this drug remains effective against coronaviruses that have developed resistance to remdesivir. Initially developed by researchers at Emory University, Ridgeback Biotherapeutics subsequently acquired the development rights. Recently, Merck & Co. (MSD) entered into a research collaboration with Ridgeback to jointly develop this antiviral agent.

These two randomized, placebo-controlled Phase 2 clinical trials will enroll adult patients aged 18 years or older with COVID-19. The study designated as 2003 will recruit newly diagnosed COVID-19 patients exhibiting symptoms in non-hospital settings, while the clinical study designated as 2004 will enroll hospitalized COVID-19 patients. The primary clinical endpoints for both studies are the time required to achieve a negative polymerase chain reaction (PCR) test result for viral detection and the safety of the therapy. Additionally, researchers will conduct virological assessments using methods such as PCR and viral culture.

“We are pleased to have advanced from preclinical studies to clinical efficacy trials within two months,” said Dr. Wayne Holman, co-founder of Ridgeback Therapeutics. “The goal of these clinical trials is to evaluate whether EIDD-2801 can rapidly clear SARS-CoV-2 in the early stages of infection. If EIDD-2801 clears the virus more rapidly than placebo, it has the potential to alter disease progression. Halting disease progression in its early stages may reduce the duration during which patients can transmit the virus, thereby changing the course of the pandemic.”

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