Watch out, Sanofi and Regeneron. Eli Lilly’s Dupixent rival has posted another round of data showing improvement in atopic dermatitis when combined with topical corticosteroids in a phase 3 trial.
With the latest results from the late-stage ADhere trial, lebrikizumab met all its primary and key secondary endpoints. Lilly was aiming to show that its drug could work as a combo therapy by clearing skin at the 16-week point in the study. Other goals included skin improvement, itch relief, and improvement of itch interference in sleep and quality of life.
Lilly picked up the anti-IL-13 antibody in its $1.1 billion Dermira buyout in January 2020. At that time, the dermatology-focused biotech had tested lebrikizumab in a phase 2b trial that linked the therapy to symptom improvements comparable to Dupixent’s.
The Indianapolis-based pharma giant is hoping to bring up a successor to the dermatology king Dupixent, which is jointly made by Sanofi and Regeneron. The approved med rakes in billions for the two companies each year, including the most recent quarter when Sanofi recorded 3.7 billion euros ($4.2 billion) in sales for the first nine months of 2021.
To make its case, Lilly is piling on the data. These latest phase 3 results complement an August readout for the late-stage ADvocate 1 and ADvocate 2 studies, which trialed lebrikizumab alone. The therapy reduced itch and interference of itch in sleep and improved quality of life at Week 16, meeting all the trial goals.
The latest ADhere trial, which featured patients whose symptoms were not well controlled with steroids alone, matches up nicely with the earlier results. Safety was consistent with the earlier studies. The most common adverse events were conjunctivitis (pink eye) and headache.
Lilly plans to release more data on all three trials at future scientific forums in 2022, when it will also shoot for regulatory filings in this indication along with partner Almirall. While Lilly holds the rights for lebrikizumab in the U.S. and the rest of the world outside of Europe, Almirall will pick up development and commercialization duties for dermatology indications, including atopic dermatitis, in Europe.
Lebrikizumab was sold to Dermira by Roche for $80 million upfront in 2017 after it struggled in asthma. That means the Swiss pharma is up for more than $1 billion in milestone payments if the therapy is a success.
Dupixent is approved in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. Demira was eyeing multiple indications when it signed the deal with Roche, but, so far, only the atopic dermatitis indication is listed in Lilly’s pipeline.
Roche retained the rights to the therapy in interstitial lung diseases, which include idiopathic pulmonary fibrosis. The drug is not listed on the Big Pharma’s website for any indication.