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Leo Pharma's eczema drug meets phase 3 trial goals, but leaves analysts guessing


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Leo Pharma's eczema drug meets phase 3 trial goals, but leaves analysts guessing

LEO Pharma A/S announced that its eczema treatment tralokinumab met the main goal in three late-stage clinical trials, but analysts were left wondering why the company waited a year to post results that lacked details.

Tralokinumab was examined in three clinical trials, called Ecztra 1 through 3. The first two lasted 52 weeks in 802 and 794 adult patients, respectively, and the third study included 380 patients for 32 weeks. Patients had moderate to severe eczema, a common and chronic condition that makes skin red and itchy. The drug was paired with topical corticosteroids, which prevent cells from producing inflammation-causing chemicals to the applied region. Tralokinumab targets IL-13, a protein that plays a key role in eczema.

Leo said tralokinumab met all the main and secondary goals of the trial and achieved results without significant adverse events. The company did not detail how the treatment scored, but the goals of the trial were to improve the severity of eczema, reduce itching and improve quality of life.

Analysts from Evercore ISI and SVB Leerink questioned why Leo issued the results a year after the trial concluded, considering the therapy generated buzz in the fall of 2018. Evercore said the company "sat on the results for quite some time." The firm also questioned why the results were not more detailed, suggesting that the data is not competitive.

"We would have expected Leo Pharma, a small derm-focused company, to have trumpeted the competitive results of their only 'ace,'" Leerink said.

A day before Leo released the results, Dermira Inc. announced that its competing eczema treatment lebrikizumab was granted a fast-track designation from the U.S. Food and Drug Administration.

Leerink believes Dermira's therapy is superior to Leo's, because it lasts longer, is more targeted and has shown to be more tolerable in studies. The analysts said that based on limited clinical data that has been released, tralokinumab matched lebrikizumab in reducing itch. But Dermira was able to up the dose during midstage trials, earning an edge in this symptom in later trials.

Lebrikizumab previously belonged to Roche Holding AG but was off-loaded to Dermira after the therapy missed the goals of a clinical trial in asthma.

But Dermira upped the dose and has since seen some effectiveness, according to Evercore, and the drug outplayed Leo's tralokinumab in that indication, which failed in a phase 3 study.

Leo intends to submit tralokinumab for regulatory approval in eczema in 2020. Leerink said this timing suggests the company may seek a more limited label compared to lebrikizumab.