Little Leo Pharma enters the prize-fight ring with positive PhIII atopic dermatitis data. Now they just have to beat Dupixent
A day after new Sanofi CEO Paul Hudson staked his reputation and the future of the pharma giant on making Dupixent a megasuccess story, little Leo Pharma is throwing down the gauntlet on atopic dermatitis.
Three years ago Leo paid AstraZeneca $115 million to buy up rights to use tralokinumab against atopic dermatitis — with $1 billion more on the table in milestones — the Danish company says their drug has swept up positive results for all primary and secondary endpoints in three Phase III trials. Now they plan to start the final push for regulatory approvals so they can challenge the heavyweight champions in this slugfest.
To put it mildly, it’s not going to be easy — under the best of circumstances.
At the time AstraZeneca did the deal with Leo, they were busy finding assets to auction off as Pascal Soriot looked to soften the ugly financial blows they were taking as revenue slid steadily downward. AstraZeneca — which over the last year has enjoyed a long-awaited turnaround — kept their big late-stage effort for tralokinumab in asthma, convinced that the IL-13 drug could be a game-changer. Instead, it failed in 3 straight late-stage trials and Soriot ended up punting it out of the pipeline.
Leo, though, never veered away. Today’s statement only heralds the top line results, with none of the data details that will be crucial if they intend to be competitive in an intensely competitive field.
Evercore ISI’s Umer Raffat finds the whole tralo saga intriguing, noting that Leo has evidently been sitting on the results for about a year. That’s not a good sign. And it left him with several big questions:
- Why would a company put out first press release on Ph 3s over a year after they were completed? Not clear
- Why didn’t Leo put out actual efficacy data in today’s update? Not clear
- My best guess: tralo data are not competitive. But I can’t know for sure.
In a followup to this story, Leo’s communications team got in touch to say that Raffat was wrong about the year-long delay, noting that the trials were scheduled to wrap up in a series, starting last August. I responded by asking when the first Phase III data were actually delivered. This morning, they replied — without answering the question.
Before issuing any communications on the development progress of tralokinumab, it was necessary to evaluate all primary and secondary outcome measures from all three pivotal Phase 3 clinical trials, in addition to adverse events. The full data set for the blinded 52-week trials plus additional weeks for safety follow-up was not available for analysis until November 2019.
Standard operating procedure in the industry is to report the data out by trial as it is available. The spokesperson for the company, though, said Leo didn’t release any hard data to avoid damaging their chances of getting the data published in a peer-reviewed journal.
Raffat also points out there’s another late-stage IL-13 in the AD mix: Dermira’s $DERM lebrikizumab, which Roche out-licensed after they had their own failed effort in asthma, with one successful Phase III and one flop.
Then there are the JAK drugs like Xeljanz, which is approved for atopic dermatitis with a black box safety warning. Eli Lilly has been bullish about Olumiant, amid skepticism. Safety is a concern with all the JAKs, which is one reason why the Dupixent group is so bullish about their prospects. AbbVie has Rinvoq in late-stage studies, And Gilead hopes to get their break with filgotinib.
More are coming in.
Atopic dermatitis is an awful affliction, spurring lesions that provoke a powerful urge to itch, while leaving a public stigma on appearance. And it’s been a blockbuster target for a variety of players, aside from Sanofi and Regeneron. Just a few days ago J&J paid $750 million for a drug called bermekimab, with plans to run it through their own pivotal for atopic dermatitis and more.
In their release, Leo seems to be determined to find openings in the market for those who aren’t happy with the results they’re getting now.
“Despite recent treatment advances, we consistently hear from healthcare professionals around the world that additional treatment options are needed to address the different signs and symptoms for each patient,” noted Kim Kjøller, the head of R&D at Leo.
Marketing applications are headed to the regulators early next year.
Social image: Leo Pharma