- Dermira, a biotech focused on dermatology, intends to launch before year's end a late-stage program for its investigational eczema drug now that the company has positive Phase 2b results in hand.
- Three regimens of Dermira's lebrikizumab hit the primary endpoint of that mid-stage, placebo-controlled trial, which enrolled patients with moderate-to-severe eczema. Patients who received 125 mg of Dermira's drug every four weeks experienced a 62% improvement in the severity of their eczema after 16 weeks of treatment. The improvements were higher, at 69% and 72%, for patients getting 250 mg of lebrikizumab every four weeks and every two weeks, respectively.
- Both 250 mg regimens also achieved key secondary endpoints, while the 125 mg dose did not. In an email to BioPharma Dive, Dermira said its "current working hypothesis" for a late-stage trial is to use 250 mg every two weeks during an induction phase. Patients would then receive 250 mg maintenance therapy either every two weeks or every four weeks "in order to optimize the clinical profile for lebrikizumab."
After roughly a decade without new therapies, the eczema market recently got two with Pfizer's ointment Eucrisa (crisaborole) and Sanofi and Regeneron's injectable Dupixent (dupilumab).
Eurcrisa sales have thus far been modest, whereas Sanofi and Regeneron expect their offering, which holds indications for asthma and eczema, to hit blockbuster status this year. Though the companies don't break down sales by indication, executives from each have noted how Dupixent's uptake in the eczema space has been strong — and should continue to grow with additional approvals for younger patients.
Some patients, however, aren't responding to the newer treatments. "I have many patients for whom current therapies do not adequately address their needs," said Emma Guttman-Yassky, lead investigator of the Phase 2b lebrikizumab study and director of the Center of Excellence in Eczema at the Icahn School of Medicine at Mount Sinai, in a statement from Dermira.
Lebrikizumab acts in a related way to Dupixent, which combats inflammation by inhibiting a protein called interleukin 4 (IL-4) from binding to its receptor. Interleukin proteins help regulate the body's immune system. Rather than targeting IL-4, Dermira's drug goes after a related protein called IL-13.
In the Phase 2b study, patients treated with any of the three tested doses showed significant improvements on the Eczema Area and Severity Index (EASI) compared to placebo. Safety data were consistent with prior studies of lebrikizumab, according to Dermira, with most adverse events being mild to moderate.
"From a commercial perspective this is the best outcome we could have hoped for," Dermira said in its email to BioPharma Dive.
The study arms that received 250 mg every two weeks or every four weeks also scored statistically significant results on some key secondary measures.
In the former, 44% of lebrikizumab-treated patients achieved a reduction from baseline of at least 90% on the EASI, compared to 11% of patients on placebo. In the latter, 34% of lebrikizumab-treated patients achieved clearing or near-clearing of skin lesions and a reduction of at least two points from baseline on another scale used in eczema clinical trials, versus 15% of patients on placebo.
Dermira said it will continue to assess the mid-stage data as it decides on a Phase 3 trial design. Still, it looks as though the company will take those 250 mg regimens into Phase 3 testing.
"Based on current market research, we know that efficacy is the most important therapeutic attribute, so we believe this trial design would potentially allow us to have best in disease efficacy and a more convenient maintenance schedule which would drive additional commercial value," Dermira said in its email to BioPharma Dive.
Dermira shares opened at $13.36 apiece Monday morning, up 95% from Friday.