SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): March 18, 2019
(Exact Name of the Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation)
275 Middlefield Road, Suite 150
Menlo Park, California
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|Item 8.01|| |
On March 18, 2019, Dermira, Inc. (Dermira) issued a press release announcing positive topline results from its Phase 2b dose-ranging study of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis and posted a presentation to its website summarizing these positive topline results. The press release is being filed as Exhibit 99.1 and the presentation is being filed as Exhibit 99.2.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Dermira, Inc. Press release dated March 18, 2019.|
|99.2||Dermira, Inc. Presentation dated March 18, 2019.|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: March 18, 2019||By:|
|Andrew L. Guggenhime|
|Chief Financial Officer|
Dermira Announces Positive Topline Results from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis
All three doses of lebrikizumab met primary endpoint with statistical significance
Lebrikizumab was well-tolerated; safety profile consistent with prior studies
Efficacy and safety profile support advancement into Phase 3; planned by end of 2019
Conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT
MENLO PARK, Calif., Mar. 18, 2019 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 positive results from a Phase 2b dose-ranging study of lebrikizumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis. All three doses of lebrikizumab met the primary endpoint, demonstrating greater improvements in the Eczema Area and Severity Index (EASI) score compared to placebo. The safety profile for lebrikizumab observed in the study was consistent with prior studies evaluating this investigational therapy.
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex, which inhibits downstream signaling. 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.
These data are compelling and further demonstrate clinically that IL-13 is a key mediator in atopic dermatitis, said Emma Guttman-Yassky, M.D., Ph.D., The Sol and Clara Kest Professor, Vice Chair for Research in the Department of Dermatology, Director of the Center of Excellence in Eczema at Icahn School of Medicine at Mount Sinai and a leading study investigator. I have many patients for whom current therapies do not adequately address their needs. These data show that lebrikizumab may offer a targeted, effective and well-tolerated therapeutic approach.
Lebrikizumab Phase 2b Study Results
Across all of the doses evaluated, lebrikizumab showed a dose-dependent and statistically significant improvement in the primary endpoint, the mean percent change in EASI score from baseline to week 16. The improvement in EASI score was 62.3% for patients receiving lebrikizumab, 125 milligrams (mg), every four weeks (p=0.0165), 69.2% for patients receiving lebrikizumab, 250 mg, every four weeks (p=0.0022) and 72.1% for patients receiving lebrikizumab, 250 mg, every two weeks (p=0.0005) compared to 41.1% for patients receiving placebo.
Patients treated with lebrikizumab at the 250 mg dose every two or four weeks achieved statistically significant improvements in other key efficacy measures compared to placebo after 16 weeks of treatment, including:
Lebrikizumab 250 mg every four weeks:
33.7% of lebrikizumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigators global assessment (IGA) score of 0 or 1, and a reduction of at least 2 points from baseline, compared to 15.3% with placebo (p=0.0392).
56.1% of lebrikizumab treated patients achieved a reduction of at least 75% from baseline in EASI score (EASI-75), compared to 24.3% on placebo (p=0.0021).
36.1% of lebrikizumab treated patients achieved a reduction of at least 90% from baseline in EASI score (EASI-90), compared to 11.4% on placebo (p=0.0062).
Lebrikizumab 250 mg every two weeks:
44.6% of lebrikizumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an IGA score of 0 or 1, and a reduction of at least 2 points from baseline, compared to 15.3% with placebo (p=0.0023).
60.6% of lebrikizumab treated patients achieved a reduction of at least 75% from baseline in EASI-75, compared to 24.3% on placebo (p=0.0005).
44.0% of lebrikizumab treated patients achieved a reduction of at least 90% from baseline in EASI-90, compared to 11.4% on placebo (p=0.0006).
The secondary endpoints for the 125 mg lebrikizumab dosing arm did not meet statistical significance.
The most common adverse events reported across all three lebrikizumab dosing arms were upper respiratory tract infection (7.5% vs. 5.8% for placebo), nasopharyngitis (6.6% vs. 3.8% for placebo), headache (3.1% vs. 5.8% for placebo) and injection site pain (3.1% vs. 1.9% for placebo). Rates of conjunctivitis (2.6% compared to no reports for placebo) and herpes infections (2.2% compared to no reports for placebo) were low. Overall, adverse events observed in lebrikizumab-treated patients were primarily mild to moderate in severity and infrequently led to treatment discontinuation.
Based on the clinical profile observed in this study, we believe lebrikizumab has the potential to be a best-in-disease therapy for atopic dermatitis, said Tom Wiggans, chairman and chief executive officer of Dermira. We intend to move quickly into a Phase 3 program following discussions with U.S. regulators. I want to thank the patients and investigators who participated in this trial and hope these contributions will support our ability to offer a new and differentiated treatment option to the millions of people struggling to effectively manage their atopic dermatitis.
Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.
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 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 at 57 sites in the United States. The study evaluated 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 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 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 4 and a body surface area involving at least 10% at screening and baseline. Following the end of the 16-week assessment period, patients are 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.
Lebrikizumab is a novel, injectable, humanized 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.
Conference Call and Webcast
Dermira will host a webcast and conference call today beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. Analysts and investors can participate in the conference call by dialing (877) 359-9508 for domestic callers and (224) 357-2393 for international callers using the conference ID# 7987427. The webcast can be accessed live on the Investor Relations page of Dermiras website, http://investor.dermira.com, and will be available for replay for 30 days following the call.
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 companys approved treatment, QBREXZA (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages nine and older) with primary axillary hyperhidrosis (excessive underarm sweating). Please see the QBREXZA prescribing information. Dermira is also evaluating lebrikizumab for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and plans to initiate a Phase 3 clinical development program by the end of 2019; and 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 Dermiras 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: Dermiras goal of bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; Dermiras plans to expedite initiation of a Phase 3 development program for lebrikizumab and to initiate the program by the end of 2019; lebrikizumabs potential to be a best-in-disease therapy for atopic dermatitis; Dr. Guttman-Yasskys belief that lebrikizumab may offer a targeted, effective and well-tolerated therapeutic approach; Dermiras anticipated end-of-Phase 2 meeting with the U.S. Food and Drug Administration; and Dermiras ability to offer lebrikizumab as a new treatment option to the millions of people struggling to effectively manage their 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 Dermiras dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; the design, implementation and outcomes of Dermiras clinical trials; the outcomes of future meetings with regulatory agencies; Dermiras ability to attract and retain key employees; Dermiras ability to obtain necessary additional capital; market acceptance of Dermiras potential products; the impact of competitive products and therapies; Dermiras ability to manage the growth and complexity of its organization; Dermiras ability to maintain, protect and enhance its intellectual property; and Dermiras 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 Dermiras Annual Report on Form 10-K, Dermiras 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 Dermiras 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.
Vice President, Corporate Communications
Ian Clements, Ph.D.
Vice President, Investor Relations
Lebrikizumab P2b Topline Results March 18, 2019 Exhibit 99.2
This presentation contains "forward-looking" statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportunities; the size of the atopic dermatitis market, the successful completion of, and timing expectations for the receipt and announcement of efficacy and safety data from our Phase 2b lebrikizumab clinical trial, timing of initiation of a Phase 3 lebrikizumab program. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements, including, but not limited to, those related to our dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; our ability to obtain necessary additional capital; market acceptance of our product; the impact of competitive products and therapies; our ability to attract and retain key employees; the costs of our commercialization plans and development programs; the design, implementation and outcomes of our clinical trials; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission (SEC) from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update any forward-looking statements after the date of this presentation except as may be required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Projections, assumptions and estimates of the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. We use our website (www.dermira.com), LinkedIn page (www.linkedin.com/company/dermira-inc-), Instagram account and corporate Twitter account (@DermiraInc) as channels of distribution of information about our company, product candidates, planned announcements, attendance at upcoming conferences and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website, LinkedIn page, Twitter account and Instagram page in addition to following our SEC filings, press releases, public conference calls and webcasts. Forward-Looking Statements
Executive Summary Clinical profile has the potential to significantly alter the treatment landscape in AD Selective inhibition of IL-13 with lebrikizumab could be the best approach to treating AD All three doses of lebrikizumab met primary endpoint with statistical significance Robust dose-dependent efficacy across multiple measures Well-tolerated with safety profile consistent with prior studies Results warrant rapid advancement to Phase 3 program; planned by end of 2019 after End-of-Phase 2 meeting with FDA
Lebrikizumab offers a differentiated mechanism of action that has the potential to be a best-in-disease therapy for treating AD IL-13/IL-4 class is a validated, targeted approach Biologic atopic dermatitis therapy is a large and growing market Predicted to be as large as approximately $14.8 billion by 20251 Need for new, differentiated therapies Phase 2b study confirms thesis that lebrikizumab may potentially offer a compelling combination of efficacy, safety, tolerability, convenience and ease-of-use Lebrikizumab: Compelling Investment Thesis Phase 2b topline results announced on March 18, 2019 Planned Phase 3 initiation by end of 2019, after End-of-Phase 2 meeting; expect topline data first half 20212 1. Decision Resources (2017); 2. Estimate provided as of March 18, 2019. Expected topline results timing assumes Phase 3 initiation by year-end 2019
Phase 2b Study to Optimize Product Profile Study objectives Optimize dosing regimen to enhance product profile Define monotherapy profile Screen Lebrikizumab 250 mg LD, followed by 125 mg Q4W Lebrikizumab 500 mg LD, followed by 250mg Q4W Lebrikizumab 500 mg LD (wk 0 & 2), followed by 250 mg Q2W Placebo Q2W Randomize (2:3:3:3) (n=280*) End of Treatment Baseline Week 16 Key inclusion criteria Adults with moderate-to-severe AD not adequately controlled with topicals or for whom topical treatment is medically inadvisable TCS washout prior to randomization Key endpoints (response rates at week 16) Primary endpoint Percent change in EASI Secondary endpoints include: ≥ 2-point reduction from baseline and a final IGA score of 0/1 EASI-50, EASI-75, EASI-90 Pruritus NRS Abbreviations: Q2W (every 2 weeks), Q4W (every 4 weeks), TCS (topical corticosteroids), IGA (Investigator Global Assessment), EASI (Eczema Area and Severity Index), NRS (numerical rating scale). Over the 16-week period, approximately 56% in the placebo arm discontinued compared to approximately 22% across the lebrikizumab dosing arms. Study Design:
Study Protocol Key Inclusion criteria Chronic AD has been present for ≥1 year before screening visit EASI score ≥16 at screening and baseline visits IGA score of 3 or 4 (scale of 0 to 4) at screening and baseline visits ≥10% body surface area (BSA) of AD involvement at screening and baseline visits Statistical analysis considerations Statistical tests were two sided and performed at the 0.05 level of significance The primary method of handling missing efficacy data was the Markov Chain Monte Carlo (MCMC) multiple imputation Rescue treatment Patients were permitted rescue therapy, including topical corticosteroids, in all arms recommended by the investigator If patients used systemic therapy, they had to discontinue the treatment Approximately 13% and 35% received rescue therapy in the treatment and placebo arms, respectively
Select Baseline Disease Characteristics Dermira data on file 125 mg Q4W (n=73) 250 mg Q4W (n=80) 250 mg Q2W (n=75) Placebo (n=52) EASI Score n 73 80 75 52 Mean 29.852 26.146 25.477 28.903 SD 13.5174 10.1346 11.2057 11.7900 IGA (%) n 73 80 75 52 3 - Moderate 43 (58.9%) 54 (67.5%) 53 (70.7%) 32 (61.5%) 4 - Severe 30 (41.1%) 26 (32.5%) 22 (29.3%) 20 (38.5%) BSA n 73 80 75 52 Mean 45.5 41.1 39.4 46.5 SD 24.49 20.89 21.49 22.68 Pruritus Score n 68 77 69 49 Mean 7.6 7.1 7.6 7.4 SD 1.98 2.44 1.87 2.42 DLQI Score n 72 80 75 52 Mean 14.5 14.2 14.1 14.1 SD 7.10 7.66 6.94 7.07
Primary Endpoint: EASI Improvement p = 0.0165 p = 0.0022 p = 0.0005
Efficacy: Investigators Global Assessment p = 0.0392 p = 0.0023 Response Rate (% of Patients)
Efficacy: EASI-75 p = 0.0021 p = 0.0005 Response Rate (% of Patients)
Efficacy: EASI-90 p = 0.0062 p = 0.0006 Response Rate (% of Patients)
Pruritis: NRS, >4 Point Improvement p = 0.1067 p = 0.0008 Response Rate (% of Patients) All data reported are observed values.
Adverse Events: Lebri Was Well Tolerated Most Frequent Adverse Events Placebo (n=52) 125mg Lebri Q4W (n=73) 250mg Lebri Q4W (n=80) 250mg Lebri Q2W (n=75) All Lebri (n=228) Upper Respiratory Tract Infection 3 (5.8%) 6 (8.2%) 9 (11.3%) 2 (2.7%) 17 (7.5%) Nasopharyngitis 2 (3.8%) 4 (5.5%) 2 (2.5%) 9 (12.0%) 15 (6.6%) Fatigue 0 0 4 (5.0%) 0 4 (1.8%) Headache 3 (5.8%) 2 (2.7%) 1 (1.3%) 4 (5.3%) 7 (3.1%) Injection Site Pain 1 (1.9%) 0 3 (3.8%) 4 (5.3%) 7 (3.1%) Herpes Zoster 0 0 1 (1.3%) 1 (1.3%) 2 (0.9%) Herpes Infections 0 2 (2.7%) 2 (2.5%) 1 (1.3%) 5 (2.2%) Conjunctivitis 0 1 (1.4%) 3 (3.8%) 2 (2.7%) 6 (2.6%) Dermira data on file
Dupilumab Profile Can Be Improved Upon Endpoints Dupilumab – SOLO 11 Dupilumab – SOLO 21 Dupilumab – P2b2 Efficacy IGA: Score of 0 to 1, “Clear” or “Almost Clear” 38% vs. 10% 36% vs. 8% 30% vs. 2% Improvement in EASI Score 72% vs. 38% 67% vs. 31% 71% vs. 20% EASI-50 69% vs. 25% 65% vs. 22% 78% vs. 30% EASI-75 51% vs. 15% 44% vs. 12% 53% vs. 12% EASI-90 36% vs 8% 30% vs. 7% 30% vs. 3% Pruritus Improvement (NRS): > 4 point Improvement 41% vs. 12% 36% vs. 10% NR % change in Peak Weekly Averaged Pruritus NRS 51% vs. 27% 47% vs. 18% 46% vs. 0.4% Safety and Tolerability Serious AE % AEs > 1% Incidence Serious AEs: 3% vs. 5% Injection Site Reaction: 10% vs. 5% Conjunctivitis: 10% vs. 2% Oral Herpes: 4% vs. 2% Oral Herpes simplex virus infection: 2% vs. 1% Data reported under SOLO 1 is combined safety from SOLO 1 and SOLO2 Serious AEs: 2% vs. 7% Injection Site Reaction: NR Conjunctivitis: 5% vs. 3% Oral Herpes: 5% vs. 0% Oral Herpes simplex virus infection: 3% vs. 0% Dosing Dosing Frequency and Loading loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) 1. NEJM 2016;375:2335-48, 2. Lancet 2016; 387; 40-52
Conclusions These data suggest that taking a selective approach to addressing IL-13 inhibition with lebrikizumab may be the best approach to treating AD Based on the compelling efficacy results observed, lebrikizumab may have the potential to be a truly differentiated therapy and may offer a best-in-disease treatment option for patients living with AD These data suggest that lebrikizumab may also be differentiated on its safety, tolerability and dosing profile Plan to have End-of-Phase 2 meeting with FDA and initiate Phase 3 program by end of 2019
Thank You Company Contact: Ian Clements, PhD email@example.com ©2019 Dermira, Inc. All rights reserved. “Dermira” is a registered trademark in the United States and other countries. A trademark application for “Dermira” and logo is pending in the United States. All other service marks, trademarks and tradenames appearing in this presentation are the property of their respective owners. Solely for convenience, the trademarks and tradenames referred to in this presentation appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames. The information herein is for informational purposes only and represents the current view of Dermira, Inc. as of the date of this presentation (or as of an earlier date if specifically noted).