– Detailed primary results of lebrikizumab Phase 2b study to be presented at the Fall Clinical Dermatology Conference
– Data reflect potential of lebrikizumab to offer best-in-disease combination of safety, efficacy, tolerability, convenience and ease of use
– Conference call and webcast to be held on October 17 to discuss data and provide overview of Phase 3 clinical development program
MENLO PARK, Calif.–(BUSINESS WIRE)–Dermira, Inc. (NASDAQ: DERM), 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, today announced that detailed primary results of its Phase 2b study of lebrikizumab in patients with moderate-to-severe atopic dermatitis will be reported at the 39th Annual Fall Clinical Dermatology Conference in Las Vegas, NV, October 17-20, 2019. In addition, the company will host a conference call and webcast on October 17, 2019, during which Dr. April W. Armstrong will discuss the data presented and company management will provide an overview of the lebrikizumab Phase 3 clinical development program.
“As a prevalent, debilitating condition with limited treatment options, moderate-to-severe atopic dermatitis remains a significant, unmet medical need,” said Tom Wiggans, chairman and chief executive officer at Dermira. “This year, we have made tremendous strides in our commitment to help address this need, producing Phase 2b results that support our belief that lebrikizumab can be a best-in-disease treatment option for the more than 10 million Americans who suffer with this condition, and rapidly advancing the program into Phase 3 development. We look forward to sharing more details about these exciting results and the program we have designed to deliver what we believe will be an important, new therapy to atopic dermatitis patients and the healthcare professionals who care for them.”
Fall Clinical Dermatology Conference Poster Presentation
The poster, described below, will be available for viewing on Friday and Saturday during the meeting. Dermira expects these data will also be included and discussed during atopic dermatitis presentations during the conference.
Lebrikizumab, a High Affinity IL-13 Inhibitor, Improves Clinical Manifestations in Moderate-to-Severe Atopic Dermatitis: Primary Results from a Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Phase 2b Study
Date and time:
Friday, October 18 from 7:00 a.m. to 4:30 p.m. PT
Saturday, October 19 from 7:00 a.m. to 1:00 p.m. PT
Poster Gallery located between the Lafite and Latour Ballrooms, Wynn Las Vegas Hotel
Lebrikizumab Program Update Webcast
On October 17, 2019 at 1:45 p.m. PT, April W. Armstrong, MD, 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, will discuss the Phase 2b data presented during the Fall Clinical Dermatology Conference. Dermira management will also provide an overview of the lebrikizumab Phase 3 development program, the initiation of which was previously announced. The live audio webcast and an archive of the presentation will be available in the investor relations section of Dermira’s website at: https://investor.dermira.com.
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 a broad spectrum of signs and symptoms that includes skin rashes that often cover much of the body, as well as intense, persistent itching, which together can have a significant 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.
Lebrikizumab is an investigational novel, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
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, develop and commercialize leading-edge medical dermatology products. 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). Please see the QBREXZA prescribing information. Dermira is currently evaluating lebrikizumab in a Phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and also has early-stage research and development 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.
The information in this news 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 news release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to Dermira’s goal of bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; the potential of lebrikizumab to offer best-in-disease combination of safety, efficacy, tolerability, convenience and ease of use and to be a best-in-disease treatment option for the more than 10 million Americans who suffer from atopic dermatitis; Dermira’s plans to rapidly advance the lebrikizumab program through Phase 3 development; and Dermira’s belief that the design of its lebrikizumab Phase 3 program will deliver an important, new therapy to atopic dermatitis patients and the healthcare professionals who care for them. 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 Dermira’s dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; the design and implementation of Dermira’s clinical trials; the outcomes of future meetings with regulatory agencies; Dermira’s ability to attract and retain key employees; 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 its material contractual obligations, 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 news 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.
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