Yesterday afternoon, Dermira Inc. (DERM:NASDAQ), a biopharmaceutical company that states it is "dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions," announced that detailed primary results from its Phase 2b dose-ranging study of lebrikizumab are being presented during the 39th Annual Fall Clinical Dermatology Conference in Las Vegas. The company previously advised that lebrikizumab is now also being evaluated in a Phase 3 program in adult and adolescent patients with moderate-to-severe atopic dermatitis.
The company notes that the lebrikizumab Phase 2b study was "designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and establish a dosing regimen for the Phase 3 program in patients with moderate-to-severe atopic dermatitis." The study enrolled 280 patients ages 18 years and older in the U.S with moderate-to-severe atopic dermatitis. Three different lebrikizumab treatment dosing arms were evaluated, compared to a placebo arm. Initial topline findings from the Phase 2b study were previously reported, showing across "all doses evaluated, lebrikizumab demonstrated dose-dependent and statistically significant improvements in the primary endpoint."
April W. Armstrong, M.D., MPH, professor of dermatology and associate dean of clinical research at the University of Southern California Keck School of Medicine and an investigator in the lebrikizumab study, commented, "These results are encouraging and suggest that lebrikizumab has the potential to advance the standard of care for patients with moderate-to-severe atopic dermatitis by delivering improvements in efficacy, tolerability and convenience relative to available therapies...In this study, lebrikizumab administered once every two or four weeks demonstrated robust, broad efficacy with a safety profile consistent with the substantial prior experience with this and other biologics targeting the IL-4/-13 pathway. Among these encouraging results, I am particularly excited about the impact of lebrikizumab on itch, which is one of the most burdensome symptoms for many atopic dermatitis patients."
Dermira's chief medical officer, dermatologist Eugene A. Bauer, M.D., added, "Our goal with lebrikizumab is to develop a best-in-disease therapy for patients with moderate-to-severe atopic dermatitis that not only improves the severity of disease, but that is also safe and convenient...These results support our belief that specifically targeting IL-13 with lebrikizumab has the potential to deliver on all of these objectives and thus help address the substantial unmet medical need in this prevalent, debilitating condition."
Dermira is a biopharmaceutical company headquartered in Menlo Park, Calif., that focuses on delivering new therapies to millions of patients living with chronic skin conditions. The company's approved treatment, QBREXZA (glycopyrronium) cloth, is indicated for pediatric and adult patients with primary axillary hyperhidrosis (excessive underarm sweating). The firm is currently evaluating lebrikizumab in a phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis, which is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood.
Dermira has a market capitalization of about $309.5 million with 54.4 million shares outstanding, and as of yesterday, the company had a short interest of around 10%. The stock has a 52-week price range of $5.25–15.48. This morning, DERM shares opened at $5.80 (+$0.11, +1.93%) over yesterday's $5.69 closing price. The stock has traded today between $5.80 and $8.52/share and is currently trading at $7.22 (+$1.51, +26.71%).[NLINSERT]
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