Dermira Completes Patient Enrollment in Phase 2b Dose-Ranging Study Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis

Globe Newswire 23-Oct-2018 4:01 PM

Topline efficacy and safety results anticipated by early April 2019   

MENLO PARK, Calif., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, today announced the completion of patient enrollment in the Phase 2b dose-ranging study evaluating its anti-IL13 monoclonal antibody, lebrikizumab, in patients with moderate-to-severe atopic dermatitis. The company expects to announce topline efficacy and safety results from the study by early April 2019.

"For many living with moderate-to-severe atopic dermatitis, the condition can often be debilitating, with patients finding limited treatment options that are effective at addressing the underlying cause of the disease," said Luis Peña, chief development officer of Dermira. "Given the role of IL-13 in the development of atopic dermatitis, we believe that lebrikizumab's distinctive molecular profile could deliver a compelling combination of efficacy, safety and convenience to patients living with moderate-to-severe atopic dermatitis. We look forward to sharing the results by early April of next year."

Lebrikizumab Phase 2b Study
The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study is designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and to establish the dosing regimen for a potential Phase 3 program in patients with moderate-to-severe atopic dermatitis. The study enrolled 280 patients ages 18 years and older with moderate-to-severe atopic dermatitis in the United States. The study is evaluating three different lebrikizumab treatment dosing arms compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion:  

• Group 1: A loading dose of 250 mg of lebrikizumab at week 0, followed by 125 mg of lebrikizumab every four weeks.
   
• Group 2: A loading dose of 500 mg of lebrikizumab at week 0, followed by 250 mg of lebrikizumab every four weeks.
   
• Group 3: A loading dose of 500 mg of lebrikizumab at each of weeks 0 and 2, followed by 250 mg of lebrikizumab every two weeks.
   
• Group 4: Placebo at week 0 and every two weeks thereafter.

The primary endpoint of the study is the percent change in the Eczema Area Severity Index (EASI) from baseline to week 16. Key secondary endpoints that will be evaluated during the 16-week treatment period include: the proportion of patients with a 75 percent improvement from baseline in EASI (EASI-75); the proportion of patients with an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and a reduction of 2 or more points (on a 5-point scale) from baseline; the proportion of patients achieving EASI-50 and EASI-90; and changes in pruritus (itch) and sleep loss scores from baseline, both scored using an 11-point numerical rating scale (NRS). Key inclusion criteria for patients enrolled in this study included chronic atopic dermatitis for at least one year, an EASI score of 16 or greater, an IGA score of 3 or greater, and a body surface area involving at least 10 percent at screening and baseline. Following the end of the 16-week assessment period, patients will be followed for an additional 16 weeks.

About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The skin condition can have a negative impact on patients' mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.

About Lebrikizumab
Lebrikizumab is a novel, humanized monoclonal antibody designed to bind IL-13 with high affinity, specifically preventing the formation of the IL-13Ra1/IL-4Ra heterodimer complex and subsequent signaling. IL-13 plays a central role in type 2 inflammation and is an important pathogenic mediator in atopic dermatitis.

About Dermira
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. The company's approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Dermira is also evaluating lebrikizumab in a Phase 2b clinical trial for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and has early-stage research programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on Twitter, LinkedIn and Instagram.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com), LinkedIn page (https://www.linkedin.com/company/dermira-inc-), corporate Instagram account (https://www.instagram.com/dermira_inc/) and corporate Twitter account (@DermiraInc) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira's website, LinkedIn page, Instagram and Twitter accounts in addition to following its SEC filings, news releases, public conference calls and webcasts.

Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: Dermira's goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; the successful completion of, and timing expectations for the receipt and announcement of topline efficacy and safety results from the Phase 2b dose-ranging study; the belief that lebrikizumab's distinctive molecular profile could deliver a compelling combination of efficacy, safety and convenience to patients living with moderate-to-severe atopic dermatitis; the desired outcome of the Phase 2b dose-ranging study; the design and description of the Phase 2b dose-ranging study of lebrikizumab for moderate-to-severe atopic dermatitis; and a potential Phase 3 program to evaluate the safety and efficacy of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of Dermira's clinical trials; Dermira's dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira's ability to attract and retain key employees; Dermira's ability to obtain necessary additional capital; market acceptance of Dermira's potential products; Dermira's ability to develop and maintain collaborations and license products and intellectual property; the impact of competitive products and therapies, including generics and biosimilars; Dermira's ability to manage the growth and complexity of its organization; Dermira's ability to maintain, protect and enhance its intellectual property; and Dermira's ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled "Risk Factors" set forth in Dermira's Annual Report on Form 10-K, Dermira's Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira's forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

Media:
Erica Jefferson
Vice President, Corporate Communications
650-421-7216
media@dermira.com

Investors:
Ian Clements, Ph.D.
Vice President, Investor Relations
650-422-7753
investor@dermira.com