Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data

Eli Lilly is hustling to the FDA with its antibody therapy for a speedy emergency use authorization (EUA) as it also reveals new data for a combo therapy.

Lilly said that it has now submitted an initial request for EUA for LY-CoV555 on its own, specifically in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. It will wait until November to ask for a EUA on the new cocktail therapy.

A few weeks back, Lilly linked its anti-SARS-CoV-2 antibody to a lower rate of hospitalization in patients recently diagnosed with mild to moderate cases of COVID-19.

However, two of the three doses, including the highest studied in the phase 2 trial, failed to beat placebo in terms of reducing viral load by Day 11.

Only the 2800-mg dose met the primary endpoint. The other two doses—700 mg and 7000 mg—did no better than placebo by that yardstick. Typically, the highest dose of a drug has the biggest effect.  This left some analysts and investors unsure of what to make of the data.

Lilly, however, still sees enough promise to gun for a quick authorization.

This comes as new data from LY-CoV555—which was borne out of Fierce 15 winner AbCellera’s drug discovery engine—and a second antibody known as LY-CoV016 showed both met primary and secondary endpoints in reducing viral load, symptoms and hospitalizations in an interim peak at the data.

The new combo data have not been published in a peer-reviewed journal, but the Big Pharma did share that the randomized, double-blind, placebo-controlled phase 2 study looked at the two drugs, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting.

The combo part of the test enrolled recently diagnosed patients with mild to moderate COVID-19, who were assigned to 2800 mg of each antibody (112 patients) or placebo (156 patients).

The combination therapy significantly reduced viral load after 11 days, meeting the primary endpoint of the study. Most patients, including those receiving placebo, showed “near complete viral clearance” by Day 11.

It also found that the combo treatment reduced viral levels at Day 3 and after a week, which Lilly says are points during the course of infection “when higher viral loads are typically seen.”

The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with LY-CoV555 monotherapy.  

“The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9%) versus placebo (5.8%),” which Lilly found created a relative risk reduction of 84.5%, although this by the thinnest of margins scraped statistical significance.  

It said overall safety appeared tolerable, with several “serious infusion reactions” resolved, and patients recovering after these. Full data are expected to be published as soon as possible.

This type works in a similar way to the Regeneron antibodies now famously used to help treat President Donald Trump this week

As Lilly plans for a speedy authorization from the FDA, it said in anticipation of this it figures it could supply as many as 1 million doses of 700-mg LY-CoV555 monotherapy in the fourth quarter of 2020, with 100,000 available in October.

We will have to wait and see whether this combo approach is better than its monotherapy treatment, but Lilly said it is also looking to have enough data to support a biologics license application submission for combination therapy as early as the second quarter of next year.

"Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.

"We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available."