Dermira soars as Dupixent challenger hits midphase endpoint

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Dermira plans to start a phase 3 trial by the end of the year. (Getty Images)

Dermira has generated evidence that its treatment for moderate-to-severe atopic dermatitis can pose a challenge to Dupixent. The phase 2b data link the treatment to significant gains on an eczema scale but leave doubts about whether it can improve on the dosing of Regeneron and Sanofi’s fast-selling drug.

The experimental medicine, lebrikizumab, is an anti-IL-13 antibody Dermira licensed from Roche for an initial $80 million in 2017. After licensing the candidate, Dermira initiated a 280-patient phase 2b trial to evaluate three regimens of lebrikizumab against placebo with a view to showing the drug can come from behind to claim market share from the fast-selling Dupixent.

Dermira’s data provide some encouragement for its attempts to unseat Dupixent. All three arms beat placebo on the Eczema Area and Severity Index (EASI), but the more significant comparison for the commercial prospects of lebrikizumab is with Dupixent.

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Cross-trial comparisons are complicated by the effects of variables other than the drugs themselves. But, with that caveat, the results suggest lebrikizumab is competitive. When given at 250 mg doses every two weeks, lebrikizumab performed numerically better on EASI than Dupixent did in the trials that underpinned its approval. Dupixent was given every two weeks, too. More patients responded to the placebo in the lebrikizumab trial, complicating the comparison somewhat.

Dermira will need to run a phase 3 program to confirm the findings before filing to approval. But, with lebrikizumab outperforming Dupixent on multiple measures of safety and efficacy, Dermira’s twice-monthly regimen looks to be well set based on the available data.

Delivering better safety and efficacy data than Dupixent in phase 3 would position Dermira to claim some market share from its rival but its hand will be stronger if it can offer a more convenient dosing schedule, too. Dermira tested a once-monthly regimen in the phase 2b and emerged with data that it works without having a clear efficacy edge over twice-monthly Dupixent.

The EASI scores for once-monthly lebrikizumab and twice-monthly Dupixent are in the same ballpark. But a smaller percentage of people taking Dermira’s regimen experienced a clearing or near-clearing of skin lesions. 

For analysts and investors, the caveats to the broadly very positive readout were too minor to quell their enthusiasm. Shares in Dermira opened up 95% and analysts at Cantor Fitzgerald and Evercore ISI said the data were better than they expected. Cantor talked up the prospect of Dermira attracting a takeover offer, describing it as an “interesting asset in a consolidating industry, especially for a large-cap pharma company that already has a JAK for [atopic dermatitis] in development.” 

Dermira had $316 million in cash and investments at the end of last year and could add to its reserves via a credit facility and partner payments in the coming months, suggesting it has the money to take the drug through phase 3 itself. Dermira plans to start a phase 3 trial by the end of the year.

By then, the competitive landscape facing lebrikizumab may be a little clearer. Despite the impressive results generated by Dupixent, multiple other companies are seeking to enter the market for moderate-to-severe atopic dermatitis drugs. Leo Pharma is testing its IL-13 drug tralokinumab in multiple late-phase trials, while AnaptysBio is closing in on midphase results for its contender. 

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