Lebrikizumab Program Update October 17, 2019
Total Page:16
File Type:pdf, Size:1020Kb
Lebrikizumab Program Update October 17, 2019 DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 Forward-looking statements 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 vision for lebrikizumab, business strategy, objectives, opportunities and plans; timing expectations for the Phase 3 lebrikizumab clinical trial; the targeted profile, attributes and performance for lebrikizumab; and lebrikizumab’s potential to be a best-in-disease therapy for the treatment of atopic dermatitis. 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; the outcomes of future meetings with regulatory agencies; 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 our material contractual obligations, 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. DERMIRA | LEBRIKIZUMAB PROGRAM OVERVIEW 2 Dermira Vision for Lebrikizumab (Lebri) Potential to deliver best-in-disease therapy to atopic dermatitis (AD) patients and those who care for them There will be a large market for safe, AD is projected to become the largest Lebri may present an opportunity effective and convenient α-IL-4/13 market in dermatology. to address key market needs. biologics. • Driven by the advent of new, systemic • α-IL-4/13 biologics are establishing the • The market is and will remain ripe for therapies addressing unmet needs in market and treatment paradigm. improvements on initial systemics, moderate-to-severe patients, major- • While other approaches have shown including in efficacy, tolerability and market sales of branded, systemic promise, their full profiles and suitability convenience. therapies for AD are projected to exceed for broad adoption remain to be seen. • Clinical data suggest lebri may deliver $21B by 2027.1 • Ultimately, the scale of the market and these improvements together with the patient needs will support a range of safety of the α-IL-4/13 class. products. 1. Decision Resources (2018) Landscape & forecast: Atopic dermatitis/ Eczema. DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 3 AD Insights Following EADV 2019 What We Heard • Excitement from the dermatology community about the focus on innovation being made in AD, given the high unmet need • Continued enthusiasm for the IL-4/13 class as a new standard of care with broad efficacy and favorable safety • Focus on opportunities for improvements in key areas including: • Efficacy, particularly in itch, given the significant burden of this symptom on patients • Tolerability, particularly in view of high rates of conjunctivitis observed with dupilumab • Convenience, particularly less frequent dosing What We Saw • Consistent with what we expected based on previously reported data • Most relevant new disclosures were for JAK inhibitors • Despite efficacy, comparable to lebri, at high doses in certain cases, safety risks and tolerability challenges remain • While JAK inhibitors may play a role in a market as large and diverse as AD is expected to become, utilization may be limited, relative to that of IL-4/13 biologics DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 4 Phase 2b Study Results April W. Armstrong, MD, MPH Professor of Dermatology and Associate Dean of Clinical Research, University of Southern California Keck School of Medicine Lebrikizumab Study Investigator 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 E. Guttman-Yassky,1 A. Blauvelt,2 L. Eichenfield,3 A. Paller,4 A. Armstrong,5 J. Drew,6 R. Gopalan,6 E. Simpson7 1Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2Oregon Medical Research Center, Portland, OR, USA; 3Department of Dermatology and Pediatrics, University of California, San Diego, CA, USA, and Rady Children's Hospital, San Diego, CA, USA; 4Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 5Department of Dermatology, Keck School of Medicine at University of Southern California, Los Angeles, CA, USA; 6Dermira, Inc., Menlo Park, CA, USA; 7Department of Dermatology, Oregon Health and Science University, Portland, OR, USA DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 IL-13 is a Central Pathogenic Mediator in AD 1Brunner PM et al. J Allergy Clin Immunol. 2017;139:S65-76; 2Buzney CD et al. J Drugs Dermatol. 2016;15:165-71; 3Brandt EB et al. J Clin Cell Immunol. 2011;10:doi:10.4172/2155-9899.1000110; 4May RD et al. Cytokine. 2015;75:89-116; 5Purwar R et al. J Invest Dermatol. 2006;126:1043- 51; 6Sebire G et al. Cytokine. 1996;8:636–41; 7Oetjen LK et al. Cell. 2017;171:http://dx.doi.org/10.1016/j.cell.2017.08.006 AD, atopic dermatitis; IL, interleukin DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 7 Lebrikizumab Mechanism of Action Lebrikizumab IL-13 IL-13Rα1 IL-4Rα TYK2 JAK1 IL-13Rα2 STAT 6 “Decoy” P Lebrikizumab is a novel, high-affinity monoclonal antibody targeting IL-13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex while leaving endogenous regulation of IL-13 intact DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 8 Study Design 250 mg LD Wk 0 LEB 125 mg Q4W, n=73 500 mg LEB 250 mg Q4W, n=80 3:3:3:2 LD Wk 0 Randomization Safety follow- N=280 500 mg LD up to Week 32 Wk 0 & 2 LEB 250 mg Q2W, n=75 Placebo Q2W, n=52 Screening (≤30 days) Randomized, Double-Blind Treatmenta Week 0 Week 4 Week 8 Week 12 Week 16 Week 32 Key inclusion criteria Concomitant therapies Key endpoints • Adults with moderate-to-severe AD inadequately • TCS, TCI and prescription • Primary: % change in EASI from Baseline at Wk 16 controlled with topicals or for whom topical treatment is moisturizers washed out ≥1 wk prior • Secondary: medically inadvisable to Baseline − Skin lesions: IGA 0/1, EASI50/75/90 b − Chronic AD for ≥ 1 y • OTC emollient used bid for ≥1 wk − Pruritus: Pruritus NRS change ≥4 points and − EASI ≥16 prior to Baseline and duration of study % change from Baseline − IGA score ≥3 (5-point scale [0-4]) • Medications known to affect AD only − ≥10% BSA involvement used as rescue therapies aPatients were seen every two weeks and received all study drug injections in the clinic; bAs defined by Hanifin and Rajka AD, atopic dermatitis; bid, twice daily; BSA, body surface area; EASI, Eczema Area and Severity Index; EASI50/75/90, ≥50%/75%/90% improvement from Baseline in EASI; IGA, Investigator’s Global Assessment; IGA 0/1, score of 0 ‘clear’ or 1 ‘almost clear’ IGA from Baseline; LEB, lebrikizumab; LD, loading dose; NRS, numeric rating scale; OTC, over-the-counter; Q2W, every 2 weeks; Q4W, every 4 weeks; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; Wk, week DERMIRA | LEBRIKIZUMAB PROGRAM UPDATE – OCTOBER 2019 9 Patient Demographics and Baseline Disease Characteristics Placebo Q2W LEB 125 mg Q4W LEB 250 mg Q4W LEB 250 mg Q2W n=52 n=73 n=80 n=75 Age, mean (SD), years 42.2 (18.2) 36.7 (16.5) 40.2 (17.9) 38.9 (17.4) Male, no. (%) 28 (53.8) 27 (37.0) 33 (41.3) 26 (34.7) Race, no.