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Dermira Presents Data From Phase 2b Study of Lebrikizumab in Patients With Atopic Dermatitis at Fall Clinical Dermatology Conference

10/17/2019

- Lebrikizumab demonstrated dose-dependent improvements across endpoints spanning the range of atopic dermatitis signs and symptoms, including skin lesions and pruritus, when administered once every two or four weeks
-
Improvement in pruritus was reported as early as second day of treatment
- Consistent with prior experience, lebrikizumab was well-tolerated, with low rates of conjunctivitis
- Conference call and webcast today at 1:45 p.m. PT / 4:45 p.m. ET

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 from its Phase 2b dose-ranging study of lebrikizumab are being presented during the 39th Annual Fall Clinical Dermatology Conference in Las Vegas, NV. Lebrikizumab is currently being evaluated in a Phase 3 program in adult and adolescent patients with moderate-to-severe atopic dermatitis.

Lebrikizumab is a novel, investigational, 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 underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.

“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,” said 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. “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.”

About the Lebrikizumab Phase 2b Study

The randomized, double-blind, placebo-controlled, parallel-group 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 with moderate-to-severe atopic dermatitis at 57 sites in the United States. Three different lebrikizumab treatment dosing arms were evaluated, compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion as follows:

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

The inclusion criteria for patients enrolled in this study included the presence of chronic atopic dermatitis for at least one year, an Eczema Area and Severity Index (EASI) score of 16 or greater, an Investigator’s Global Assessment (IGA) score of 3 or 4 (on a 5-point scale ranging from 0 to 4) and body surface area (BSA) involvement of at least 10 percent at screening and baseline.

The primary endpoint of the study was the percent change in EASI from baseline to week 16. Secondary endpoints that were evaluated during the 16-week treatment period included: the proportion of patients with a 75 percent improvement from baseline in EASI score (EASI-75); the proportion of patients with a reduction of 2 or more points in IGA score from baseline to a final score of 0 (clear) or 1 (almost clear) (IGA0/1); the proportion of patients achieving EASI-50 and EASI-90; changes in pruritus (itch) and sleep loss scores from baseline, each scored using a numerical rating scale (NRS); and the proportion of patients with an improvement in pruritus NRS score (on an 11-point scale) of at least 4 points from baseline.

Newly Presented Lebrikizumab Phase 2b Study Results Presented at Fall Clinical Dermatology Conference

Initial topline findings from the Phase 2b study were previously announced in March 2019, showing that across all doses evaluated, lebrikizumab demonstrated dose-dependent and statistically significant improvements in the primary endpoint, the mean percent change in EASI score from baseline to week 16.

The data being presented highlight secondary endpoints assessing measures spanning the range of signs and symptoms of atopic dermatitis, including skin lesions (the proportions of patients achieving EASI-50, EASI-75, EASI-90 and IGA0/1) and pruritus (mean percent change in pruritus NRS score and the proportion of patients achieving an improvement of at least 4 points in pruritus NRS score) over the 16-week treatment period. Key findings include the following:

Skin Lesions

  • A response was observed as early as the first on-treatment visit at week 4 for all atopic dermatitis severity scores. Lebrikizumab demonstrated a dose-dependent response across each of the EASI-50, EASI-75, EASI-90 and IGA0/1 endpoints, with marked improvement at both the 250 mg every two weeks (Q2W) and 250 mg every four weeks (Q4W) doses.
  • A greater proportion of lebrikizumab- versus placebo-treated patients achieved EASI-50, EASI-75, EASI-90 and IGA0/1 at week 16, with statistically significant improvements seen with lebrikizumab as follows:

 

EASI-50

EASI-75

EASI-90

IGA0/1

250 mg Q2W

 

81.0%***

 

60.6%***

 

44.0%***

 

44.6%**

250 mg Q4W

 

77.0%**

 

56.1%**

 

36.1%**

 

33.7%*

125 mg Q4W

 

66.4%

 

43.3%

 

26.1%

 

26.6%

Placebo

 

45.8%

 

24.3%

 

11.4%

 

15.3%

*p<0.05, **p<0.01, and ***p<0.001 versus placebo

Pruritus (Itch)

  • Dose-dependent improvements in pruritus, as reported by patients, were observed as early as day 2 and continued through week 16.
    • By week 16, patients receiving lebrikizumab at doses of 125 mg Q4W, 250 mg Q4W and 250 mg Q2W reported mean improvements in pruritus NRS score of 36.9% (p<0.01), 48.6% (p<0.001) and 61.8% (p<0.001), compared to a mean worsening of 6.8% in patients receiving placebo.
    • The proportion of patients reporting an improvement of at least 4 points in pruritus NRS score was highest in the 250 mg Q2W group, reaching 51.9% by week 4 and at week 16, 70.0% (p<0.001 vs. placebo).

As expected, based on prior experience, lebrikizumab was generally well-tolerated, with a safety profile consistent with that observed in prior studies in more than 4,000 patients. Adverse events observed in lebrikizumab-treated patients were primarily mild to moderate in severity and infrequently led to treatment discontinuation. The most common adverse events reported across the lebrikizumab 250mg Q2W, 250mg Q4W and 125mg Q4W dosing arms were upper respiratory tract infection (2.7%, 11.3% and 8.2%, respectively, vs. 5.8% for placebo), nasopharyngitis (12.0%, 2.5% and 5.5%, respectively, vs. 3.8% for placebo), headache (5.3%, 1.3% and 4.1%, respectively, vs. 5.8% for placebo) and injection site pain (5.3%, 3.8% and 0.0%, respectively, vs. 1.9% for placebo). Rates of herpes viral infections (which includes oral herpes, herpes zoster, genital herpes, herpes simplex, and eczema herpeticum) were 2.7%, 5.0% and 2.7%, respectively, vs. 3.8% for placebo) and conjunctivitis (2.7%, 3.8% and 1.4%, respectively, vs. 0.0% for placebo) were low. Across all studies of lebrikizumab conducted to date in atopic dermatitis, conjunctivitis has been reported at low rates similar to those in patients receiving placebo.

“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,” said Eugene A. Bauer, M.D., chief medical officer at Dermira and a dermatologist. “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.”

Based on the Phase 2b study results, Dermira recently announcedthe initiation of a Phase 3 clinical development program to further evaluate lebrikizumab in adult and adolescent patients with moderate-to-severe atopic dermatitis.

Lebrikizumab Program Update Webcast

Dermira will host a webcast and conference call today beginning at 1:45 p.m. Pacific Time / 4:45 p.m. Eastern Time. 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 Phase 2b study, will discuss the data presented during the Fall Clinical Dermatology Conference. Dermira management will also provide an overview of the lebrikizumab Phase 3 development program.

Conference Call Information:
Toll-free: (866) 211-3117
International: (647) 689-6606
Conference ID: 3193467

Webcast information: Visit http://investor.dermira.com.

A webcast replay will be available on the Dermira website for 30 days.

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 range of signs and symptoms, including rashes on the skin that often cover much of the body, as well as intense, persistent itching. The 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, investigational, 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 underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.

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, 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.

Forward-Looking Statements

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; 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; Dermira’s goal to develop lebrikizumab as 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; and the belief that specifically targeting IL-13 with lebrikizumab has the potential to address the substantial unmet medical need in 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 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.

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

Erin Murphy
Director, Corporate Communications
650-422-7746
erin.murphy@dermira.com

Investors:
Andrew Guggenhime
Chief Financial Officer
650-421-7200
investor@dermira.com

Source: Dermira, Inc.

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