Eli Lilly notches another positive baricitinib eczema trial, but has Dermira made it obsolete?
Entering today, most of what you needed to know about Eli Lilly’s JAK inhibitor baricitinib could be found in two places:
In the FDA-mandated, 1,000-plus word, bolded note now appended to the end of every press release about the drug that begins: “WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS.”
And in the run-up to the JP Morgan Healthcare Conference, when Eli Lilly dropped $1.1 billion on the anti-inflammatory skin biotech Dermira – a move that SVB Leerink’s Pasha Sarraf had predicted a month prior based on the consistently meh results baricitinib had produced in Phase III trials.
Today, though, Eli Lilly announced positive results from a fifth trial. The primary endpoint was the percentage of atopic dermatitis (AD) patients who saw a 75% change in their Eczema Area and Severity Index (EASI), and it showed a far higher percentage of patients reached that level on the drug arms than on the placebo arm. For the highest dose of the drug, that was 29.5%, compared with 8.2%.
Those results are an improvement over the first Phase III trials announced earlier this year, when the same 2-milligram dose scored around 18%. But it is still behind the data Pfizer’s JAK inhibitor abrocitinib has posted on the same endpoints. And it is line with the Phase III results for a baricitinib combination treatment announced in August, a few months before Sarraf wrote a damning note about the drug and predicted Eli Lilly would acquire Dermira.
“Neither we, nor any of the KOLs with whom we have spoken believes that bari’s profile is survivable commercially in AD,” she wrote to investors on December 9.
After nearly a decade of co-developing the drug with Incyte, Lilly won approval for rheumatoid arthritis in the summer of 2018. But it came, like other JAK inhibitors, with a black box warning and strict limits on dosing, conditions the FDA made after initially rejecting the drug. It also didn’t look more effective than its rivals. Sales were anemic and Incyte washed its hands of the drug. Eli Lilly kept the trials going.
Eli Lilly has said the trials support an application for AD approval, but will another 10 percentage points on one endpoint, in one study be enough to make the drug competitive? The company doesn’t seem to be betting on it. Dermira, the new acquisition, is focused on lebrikizumab, an anti-inflammatory that got 56% of patients to achieve the benchmark 75% change in EASI score in a Phase IIb trial, plus good results on another AD endpoint: skin lesion clearing.
Eli Lilly won’t be alone in that race either. They’ll be chasing Regeneron and Sanofi’s Dupixent, which is approved and has posted similar numbers.
And both of those drugs have an advantage on baricitinib and abrocitinib. They’re IL-13 inhibitors, not JAKs (Dupixent also hits IL-4). And at minimum, that should mean a lot fewer bolded, all-caps letters in press releases and on the label.