Lilly Initiates First-in-Human Antibody Therapy Trial for COVID-19; Gilead Reports Positive Remdesivir Results in Moderate Patients

Eli Lilly Launches World’s First Clinical Trial of Antibody Therapy

Eli Lilly and Company (Lilly) announced today that LY-CoV555, a neutralizing antibody against the novel coronavirus jointly developed with AbCellera, has completed dosing of the first patient in its Phase 1 clinical trial. The press release noted that this is the world’s first human clinical trial of a potential antibody therapy for COVID-19.

LY-CoV555 is a potent neutralizing antibody that targets the spike (S) protein of SARS-CoV-2, designed to block the virus from entering cells. This investigational antibody was isolated and developed from blood samples collected from the first cohort of COVID-19 survivors in the United States. Following the initial discovery of the antibody, scientists at Eli Lilly and Company rapidly developed this antibody therapy within just three months.

The J2W-MC-PYAA clinical trial is a randomized, double-blind, placebo-controlled Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of LY-CoV555 in patients hospitalized with COVID-19. The results of this trial are expected to be available by the end of June.

If Phase 1 study results demonstrate that the antibody can be used safely, Eli Lilly and Company expects to proceed to the next stage of testing, evaluating the efficacy of LY-CoV555 in non-hospitalized patients with COVID-19. The company also plans to investigate the drug in a prophylactic setting, with a focus on vulnerable patient populations who have historically not been optimal candidates for vaccination.

“Antibody therapies such as LY-CoV555 may have dual potential for the prevention and treatment of COVID-19, and could be particularly important for populations most severely affected by the disease, such as the elderly and immunocompromised individuals,” said Dr. Daniel Skovronsky, Chief Scientific Officer of Eli Lilly and President of Lilly Research Laboratories. “While studying safety and efficacy, we have also begun large-scale production of this potential therapy. If LY-CoV555 becomes part of the near-term solution for COVID-19, we aim to make it available to patients as soon as possible, with a target of producing hundreds of thousands of doses by year-end.”

Eli Lilly and Company has also partnered with Junshi Biosciences to jointly develop neutralizing antibodies targeting the novel coronavirus. Recently, the candidate antibody co-developed by the two companies demonstrated its preventive and therapeutic potential in rhesus macaque animal studies. The parties plan to advance the clinical trial application for the antibody in the second quarter. Eli Lilly intends to test various neutralizing antibodies against the novel coronavirus, either as monotherapies or as part of antibody cocktail therapies, for their efficacy in treating COVID-19 patients in the coming months.

Gilead Sciences Announces Results of Remdesivir Treatment in Patients with Moderate COVID-19

Today, Gilead Sciences announced the clinical trial results of its antiviral drug remdesivir for treating hospitalized patients with moderate COVID-19. In this open-label Phase 3 clinical trial, a 5-day course of remdesivir combined with standard care increased the likelihood of clinical improvement by 65% on Day 11 post-treatment (OR=1.65, 95% CI, 1.09-2.48, p=0.017). A 10-day course of remdesivir also showed benefits in terms of clinical improvement compared to standard care, but the results did not reach statistical significance. The company plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

Previously, data from multiple Phase 3 clinical trials of remdesivir for the treatment of severe COVID-19 had already been published. The distinguishing feature of this trial is its focus on patients with moderate COVID-19, defined as those who, despite a confirmed diagnosis of COVID-19 and hospitalization for treatment, did not require mechanical ventilation and maintained an oxygen saturation greater than 94% while breathing ambient air. Patients were randomized in a 1:1:1 ratio to receive either a 5-day course of remdesivir, a 10-day course of remdesivir, or standard care. The primary endpoint was the clinical status assessed on Day 11 after treatment initiation using a 7-point ordinal scale. This 7-point scale ranges from hospital discharge to increasing levels of oxygen and ventilatory support, up to death.

The trial results showed that on day 11 after treatment, the proportion of patients achieving clinical status improvement was significantly higher in the 5-day treatment group compared to the standard care group. In addition, the number of patients receiving remdesivir who experienced clinical status deterioration or death was lower than that in the standard care group, but this difference did not reach statistical significance.

“We now have multiple randomized, controlled clinical trials demonstrating that remdesivir improves clinical outcomes across different patient populations. Today’s results show that, in the treatment of moderate disease, a 5-day course of remdesivir leads to greater clinical improvement compared with standard care,” said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences. “The additional data we have today will further guide our research efforts, including evaluating the efficacy of the therapy at earlier stages of disease, combining it with other therapies to treat the most critically ill patients, conducting pediatric studies, and developing alternative formulations.”

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