Dermira, Inc. (DERM - Free Report) announced that it has started dosing in a phase III study, evaluating its monoclonal antibody candidate, lebrikizumab, in patients with moderate-to-severe atopic dermatitis, the most common form of eczema, aged 12 years or older.
The phase III study is part of the phase III program, which includes two identical phase III studies to evaluate safety and efficacy of lebrikizumab as monotherapy in patients. The studies will enroll a total of 800 patients suffering from chronic atopic dermatitis. The patients will be administered a loading dose of 500mg at day zero and at Week 2, followed by a 250mg dose every two weeks in the first 16 weeks of induction period. Patients responding to lebrikizumab monotherapy during the induction period will further given 250mg dose every two weeks, 250mg every four weeks or will be administered a placebo every two weeks for a period of 36 weeks.
The primary endpoints of the studies will be based on percentage of patients achieving an Investigator’s Global Assessment score of one or zero. Dermira expects top-line data from the 16-week induction period to be available in the first half of 2021.
The company also has plans to include an additional study in the phase III program later, which will evaluate lebrikizumab in combination with topical corticosteroids.
Shares of Dermira have declined 21.1% so far this year compared with the industry’s decrease of 2.3%.
Positive data from the phase IIb study, evaluating lebrikizumab in patients with moderate-to-severe atopic dermatitis were announced in March Data from the study showed that treatment with the candidate achieved improvements of statistical significance compared to place as measured by Eczema Area and Severity Index score.
Notably, many companies are developing medicines to address atopic dermatitis /eczema. Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) market Dupixent for treating atopic dermatitis. Others key immunology candidates in late-stage studies for atopic dermatitis include AbbVie’s upadacitiniband Lilly’s (LLY - Free Report) Olumiant.
We note that Dermira has one marketed drug, QBREXZA, which was approved in 2018 for the treatment of primary axillary hyperhidrosis (excessive underarm sweating). In the second quarter 2019, the drug registered an increase of more than 200% in sales compared to first quarter 2019. A successful development of lebrikizumab may boost the top line further. However, commercialization is years away and competition is likely to be stiff for lebrikizumab.
Dermira currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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