Fears of toxicity with Lilly’s anti-Covid-19 antibody bamlanivimab have turned out to be unfounded. The halt of the NIAID-sponsored Active-3 study, announced earlier this month, was for a more prosaic reason: the project did not work in this particular population, hospitalised patients, the company said yesterday.
Lilly still sees a path forward for bamlanivimab monotherapy in less severe patients – indeed, it has already filed for emergency use authorisation here, on the back of results from the Blaze-1 study. And after a weak third quarter, the company will need to book decent sales from its Covid-19 projects if it is to hit the higher end of its full-year sales guidance.
Still, Covid-19 revenues would merely be the cherry on top of a cake that is looking pretty unstable right now. Lilly’s share price fell 6% this morning after missing analyst expectations in the third quarter, with much of the focus on today’s earnings call falling on its diabetes franchise; namely, the disappointing performance from its marketed drug Trulicity, and the upcoming pivotal trial readout for its next big hope, tirzepatide.
The company is set to report top-line data this year from the Surpass-1 study of the GIP/GLP-1 agonist, with more detailed results set to come at a medical meeting next year, the company’s head of diabetes, Mike Mason, said.
He added that the group has “never been more excited” about tirzepatide, before later clarifying, in response to a question from an analyst, that nobody at Lilly has yet seen any data from Surpass-1.
Investors are likely warier, particularly regarding tirzepatide’s tolerability: the project has been linked with very high rates of nausea, vomiting and diarrhoea. Last month Novo Nordisk hinted that toxicity was behind its decision to discontinue its glucagon, GLP-1 and GIP tri-agonist.
With the sellside pencilling in tirzepatide sales of just over $3bn in 2026, according to EvaluatePharma, perhaps it is understandable that the Covid-19 antibody took a backseat today.
$400m Covid-19 push
Still, Lilly said that it expected to spend around $400m on Covid-19 R&D this year, not an insignificant sum.
Bamlanivimab’s use in hospitalised patients now looks like a dead end. Obtaining emergency authorisation in mild-to-moderate patients looks more doable – the FDA has given other Covid-19 projects the nod on the basis of much flimsier evidence. But the antibody could be going up against Regeneron’s Covid doublet, REGN10933 + REGN10987, which looks more promising based on the admittedly limited data available so far (Regeneron joins Lilly in validating the Covid antibody approach, September 30, 2020).
Lilly has its own Covid-19 antibody combo, bamlanivimab + etesevimab, which has shown signs of being more efficacious still, but that is not expected to be filed for an EUA until November (Two Covid-19 antibodies look better than one for Lilly, October 8, 2020).
Perhaps it is telling that Lilly had not started its own trials of bamlanivimab in hospitalised Covid-19 patients. The company has previously noted that this group might not benefit from antibody therapy because, by the time they have progressed to this stage of the disease, they might have developed their own antibodies and be mounting an inflammatory response to the virus.
Regeneron does have a study ongoing in hospitalised patients.
Lilly could do with a boost, and Covid-19 sales might provide this. But, given the transient nature of pandemics, this might not disguise the underlying issues at the company for too long.
|Trials of bamlanivimab in Covid-19|
|Trial name||Sponsor||Details||Trial ID||Note|
|Blaze-1||Lilly||Bamlanivimab and bamlanivimab + etesevimab in ambulatory patients||NCT04427501||Data reported with mono and combo therapy|
|Blaze-2||Lilly||Bamlanivimab, prevention in nursing home residents and staff||NCT04497987||Primary completion Mar 2021|
|Blaze-4||Lilly||Bamlanivimab + etesevimab, lower doses, ambulatory patients||N/A||"Initiating soon"|
|Activ-2||NIAID||Bamlanivimab, ambulatory patients||NCT04518410||Primary completion Nov 2020|
|Activ-3||NIAID||Bamlanivimab + Veklury, hospitalised patients||NCT04501978||Failed to show benefit|
|Note: bamlanivimab also known as LY3819253 and LY-CoV555; etesevimab also known as LY3832479 and LY-CoV016.
Source: Company presentation, clinicaltrials.gov.