After two rounds of mixed data, Eli Lilly impresses analysts with new Covid-19 antibody results. And execs want an EUA now

Eli Lilly has more data from their Covid-19 neutralizing antibodies — data, they say, should warrant an FDA OK.

The Big Pharma said Wednesday that a cocktail of two monoclonal antibodies looked safe and reduced viral load in Covid-19 patients. It also alleviated symptoms and reduced ER visits and hospitalization rate compared to placebo, appearing overall to provide better results than a single Lilly antibody showed in September and to compare favorably with the Regeneron antibody cocktail that President Trump received last week.

“To date we have been largely disappointed in the clinical results for COVID-19 mAbs,” Baird’s Madhu Kumar said in a note, singling out the first Lilly and Regeneron data. “In contrast, today’s … cocktail results look pretty encouraging.”

Eli Lilly also disclosed that, despite mixed signals in a Phase II, they had applied for an EUA for the single antibody. With some analysts expecting an imminent EUA for Regeneron, that could quickly double the number of FDA-authorized Covid-19 therapies from two to four.

These new data mark the third batch of results from neutralizing monoclonal antibodies, a closely-watched method to treat or prevent Covid-19 that researchers and a handful of major companies have been racing to develop for nearly a year.

Although trials are underway across a range of patient types, researchers expected the antibodies to be more effective in earlier-stage patients than later ones. But the results Eli Lilly released on a single antibody last month left as many as questions as answers. A medium dose of the drug significantly reduced viral loads in early-stage patients but neither the high dose nor the low dose did.

The results for the antibody cocktail, however, paint a clearer picture. At 2,800 mg, the drug significantly reduced viral levels compared to placebo by day 11 in symptomatic but not hospitalized patients, meeting the primary endpoint. The results were also significant for day 3 and day 7.

Consistent with the decline in viral load, patients who received the antibody also saw a greater decline in symptoms over 11 days. And, although the results were only narrowly significant (P=0.049), patients in the drug arm saw fewer hospitalizations and ER visits, with 0.9% of antibody patients and 5.8% of placebo patients winding up in medical centers.

Although more Lilly data would be needed for a full comparison, these numbers compare favorably with the data Regeneron unveiled last week.

The New York-based biotech, which had been the frontrunner in the antibody race after showing groundbreaking data from an Ebola antibody last year, revealed statistically significant results reductions in viral load from their first 275 patients. There were also numerical improvements in symptom alleviation and hospitalization rates but the results weren’t significant.

Still, the big biotech cautioned that far more patients and more data were coming, and Baird’s Brian Skorney saw today’s Eli Lilly data as potential evidence that the reductions in viral load Regeneron saw would ultimately translate into important reductions in symptoms and hospitalizations.

“All told, while early clinical data from Regeneron’s REGN-COV2 cocktail are limited to date,” he said in a note to investors, “we do find the clinical data from Eli Lilly’s two drug combination quite encouraging and believe that this data may provide proof-of-concept that reducing viral load with an antibody cocktail could lead to a clinical benefit.”

Eli Lilly said they will file for an EUA for the cocktail. They’ve already requested authorization for the single antibody at the low dose of 700 mg, saying they saw “similar clinical effects” across doses in their Phase II study. Regeneron has argued similarly, saying they would discuss a low-dose EUA from the agency despite only the high dose reaching statistical significance. Lilly, unlike Regeneron, has not released any data for the 700 mg dose.

Given the stronger data from the combination, Baird’s Kumar said they did “not expect real uptake” for the single antibody, regardless of whether it was authorized. Lilly, though, has made clear that far more of the monotherapy will be available sooner than the combination therapy.

The company said today that up to 1 million doses could be available in the fourth quarter of 2020, compared to 50,000 doses of the combo. Manufacturing of the cocktail would pick up in Q1 2021, fueled by a new agreement with Amgen. Regeneron is aiming for 300,000 doses of its cocktail this year and 250,000 doses per month next year.

There will likely be far more demand than either company can meet, Credit Suisse’s Evan Seigerman noted.

Lilly’s single antibody, LYCoV55, came from Canadian startup AbCellera. The cocktail combined LYCoV555 with an antibody developed by the Shanghai-based biotech Junshi Biosciences. Lilly has now named them bamlanivimab and etesevimab.

Kumar added that the stronger results now seen in the two cocktail trials and the mixed results from the single Lilly antibody might not bode well for the third contender in the race, Vir. The GlaxoSmithKline-partnered company recently put a single antibody into Phase III they hope can be as or more powerful than Regeneron’s cocktail. Kumar, though, argued preclinical already points to a less potent molecule and the recent cocktail data leave little wiggle room.

“Overall, given VIR-7831’s inferior biochemical and dosing profile,” he said, “today’s bamlanivimab/etesevimab data leave no room to hide for a biochemically inferior and under-dosed COVID-19 mAb in the Phase 2/3 COMET-ICE trial.”

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