Getting Beyond Prevention Inventive Strategies for COPD

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1 Getting Beyond Prevention Inventive Strategies for COPD Tim Joslin Managing Director, Europe Defined Health Webinar 17 th June, 2009

2 The information in this presentation has been obtained from what are believed to be reliable sources and has been verified whenever possible. Nevertheless, we cannot guarantee the information contained herein as to accuracy or completeness. All expressions of opinion are the responsibility of Defined Health, and though current as of the date of this report, are subject to change. Defined Health - Pg. 2

3 Defined Health is a leading business development strategy consulting firm. We have been assisting clients in the pharmaceutical, biotech and healthcare investment industries for more than 25 years. Our services, broadly described along with typical questions from our clients, include: Defined Health - Pg. 3

4 Defined Health Areas of Experience and Expertise Defined Health - Pg. 4

5 Defined Health Areas of Experience and Expertise Defined Health - Pg. 5

6 Respiratory Disease: Experience & Expertise Respiratory Disease RESPIRATORY DISEASE is an active area of research for Defined Health, and includes extensive assessments in both the Allergist and Pulmonologist side of these disorders (as well as their overlap into the PCP space). Defined Health has recently conducted a very large review of the COPD current and future management landscape, including a very granular analysis of novel MOAs. Defined Health has conducted numerous commercial evaluations of novel MOAs such as FLAP and CRTH2 inhibitors, interleukin antagonists, and historically did many analyses around leukotriene modifiers and PDE-IV inhibitors. Because of Defined Health s extensive client base of drug delivery companies, we have extensive experience looking at novel inhalation and intranasal platforms, both for next generation agents, novel agents, as well as lower risk branded generics, for asthma, allergic rhinitis, and COPD. Finally, Defined Health has conducted assessments of smaller, niche and orphan settings such as Idiopathic Pulmonary Fibrosis (IPF) and Cystic Fibrosis (CF). Defined Health - Pg. 6

7 Agenda COPD impact epidemiology, healthcare costs, unseen patients, risk factors Current therapies Underlying immunological mechanisms Regulatory & clinical trial Issues Future approaches to therapy Still unproven routes of development PDE-4 s Anti-TNFα s IL8 Old drugs, new strategies Antibacterial therapy HDAC Statins Potential ways forward? Leukotriene antagonists PI3K Conclusion Defined Health - Pg. 7

8 Definition of COPD COPD is a preventable and treatable disease with some significant extra-pulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. GOLD, ATS/ERS spirometric classification based on post-bronchodilator FEV 1 Stage 1 (FEV 1 80% predicted) Stage 2 (FEV 1 <80% predicted) Stage 3 (FEV 1 <50% predicted) Stage 4 (FEV 1 <30% predicted) COPD prevalence estimates are based on the sum of individual patients with either Chronic Bronchitis or Emphysema or a diagnosis of both conditions. GOLD executive summary Am J Respir Crit Care Med 2007 Defined Health - Pg. 8

9 COPD is a Constellation of Overlapping Disorders The implications of inadequate patient/disease categorization are multifold: Patients are not well managed by physicians as COPD is a complex disease. Epidemiology of patients defined as having COPD is not accurate. Drugs targeting modulation of underlying pathophysiology may not work across broad populations. In 1989, Snider et al published a non-proportional Venn diagram illustrating the idea that COPD encompasses a group of disorders characterized by the presence of incompletely reversible airflow obstruction with overlapping subsets of different phenotypes including chronic bronchitis, emphysema or asthma. In 2008, Marsh et al attempted to quantify the proportional classifications of Snider s original COPD phenotypes. Based on spirometry and the overlap of three respiratory disorders, there are at least 8 distinct phenotypic subgroups of COPD. KOLs consistently pointed out that one wouldn t expect a single drug to work on all of these subgroups. Am Rev Respir Dis 1989;140(3 Pt 2):S3 8; Thorax 2008;63; Defined Health - Pg. 9

10 Risk Factors for COPD Inhalation exposure Cigarette smoking % smokers develop clinically significant COPD Occupational dusts and chemicals Indoor/outdoor pollution Genetic disposition Severe hereditary deficiency of α1-antitrypsin Gender Equal prevalence in men and women higher smoking prevalence in women? Infection History of severe childhood infections Susceptibility to viral infections (due to low birth weight) Socioeconomic status Risk of developing COPD inversely proportional to socioeconomic status probably due to a combination of exposures to pollutants, cigarette smoke, poor nutritional status Defined Health - Pg. 10

11 COPD Co-morbidities Include (Gold Stage 3, 4 patients) a higher prevalence of Coronary Heart Disease, diabetes and hypertension than age/sex/smoking status matched subjects. As well as Depression, Muscle wasting and Cachexia. What does this mean for companies looking to enter the space? Defined Health - Pg. 11

12 High Burden of COPD in U.S. COPD is the 4 th leading cause of morbidity and mortality in US after CVD, cancer, Cerebrovascular disease. Predicted to become 5th major worldwide burden of disease by epidemiological estimates show 12.1M US citizens (over 18 years) having been diagnosed with COPD sum of estimated cases of emphysema (4.1M) and chronic bronchitis (9.5M) The true prevalence of persons with reduced lung function maybe as much as double this figure NHANES III included spirometry on 82% of the 20,050 nationally representative sample -- COPD prevalence estimated at 23.6M NHANES III cohort -- majority with mild/moderate disease as only 2.4M with Gold Stage 3, 4 63% of adults identified with impaired airflow were unaware of their condition Lung Health Study demonstrated patients who abstained from smoking for at least 5 years have significantly improved survival The annual cost of treating US COPD patients in 2007 was $42.6 Billion inclusive of $26.7 Billion in direct healthcare expenditures Defined Health - Pg. 12

13 Even with Explosive Epidemiology, Diabetes Represents < 15 Million Diagnosed Cases in 2005 US Dept HHS Defined Health - Pg. 13

14 High but Variable COPD Mortality by Country A typically British Disease? Defined Health - Pg. 14

15 Current Management Defined Health - Pg. 15

16 Management Algorithm for Mild COPD International Journal of COPD 2008:3(4) Defined Health - Pg. 16

17 COPD Market Value Major Classes Change to ICS/LABA Combination Therapy Driven by Spiriva Defined Health - Pg. 17

18 Current Management - Devices COPD is a multi-billion dollar market defined by pulmonary inhalation devices delivering agents that provide only symptomatic relief. Defined Health - Pg. 18

19 Treatment Effects Defined Health - Pg. 19

20 Outcomes Studies Spiriva s position is enhanced by UPLIFT study results UPLIFT was a 4 year trial sponsored by Boehringer Ingelheim with nearly 6000 patients that tested Spiriva vs. placebo. therapy with tiotropium was associated with improvements in lung function, quality of life, and exacerbations during a 4-year period but did not significantly reduce the rate of decline in FEV1. Tiotropium was associated with a significant delay in the time to the first exacerbation, with a median of 16.7 months (95% CI, 14.9 to 17.9) in the tiotropium group and 12.5 months (95% CI, 11.5 to 13.8) in the placebo group. Tiotropium was also associated with a significant delay in the time to the first hospitalization for an exacerbation. N Engl J Med 2008;359: Defined Health - Pg. 20

21 Outcomes Studies INSPIRE Shows Some Benefits of Advair INSPIRE only showed Advair to be non-inferior to Spiriva in terms of preventing acute exacerbations. Since UPLIFT was Spiriva vs. placebo, INSPIRE for GSK should help to nullify any advantage Boehringer Ingelheim may have received from UPLIFT. INSPIRE compared Advair and Spiriva in about 800 patients over 2 years. The primary endpoint was health care utilization exacerbation rate, defined as those that required treatment with oral corticosteroids and/or antibiotics or required hospitalization. The estimated overall rates of exacerbations were 1.28 per year for Advair and 1.32 per year for Spiriva, with no statistically significant difference. Secondary endpoints favored Advair, including statistically significant differences in the St. George s Respiratory Questionnaire, a survey instrument designed to assess total patient health, and, surprisingly, mortality (3% vs. 6%). More cases of pneumonia occurred in the Advairtreated patients. Recent findings from other researchers have indicated that inhaled steroids reversibly increase the risk of pneumonia in COPD patients. Am J Respir Crit Care Med Vol 177. pp 19 26, 2008 Defined Health - Pg. 21

22 Standard Bronchodilator/ICS Regimens May Decrease the Rate of Lung Function Decline..but not Enough Reducing the rate of lung function decline in COPD remains a high-priority. Long-acting bronchodilators may help in this regard (confirmatory studies are needed), but are unable reduce rates to those observed with healthy subjects. Indeed, their effects on lung function decline may be limited by a therapeutic ceiling. Thus, novel approaches may be needed to achieve the next incremental reduction in the rate of lung function decline. International Journal of COPD 2009: Defined Health - Pg. 22

23 Bronchodilator/ICS Regimens Can Reduce the Burden of COPD Exacerbations..but not Enough COPD exacerbations are associated with increase mortality and morbidity. They also represent a major driver of disease-related costs. Thus, they are prime targets for pharmacological intervention. LABAs, LAMAs, and ICSs have been shown to reduce the frequency, duration, and intensity of exacerbations. And data from the UPLIFT study suggest that triple combination therapy may be warranted. However, the overall burden associated with COPD exacerbations remains high. International Journal of COPD 2009: Defined Health - Pg. 23

24 Benefits of Smoking Cessation Defined Health - Pg. 24

25 Other Factors Apart from Smoking Clearly Contribute to COPD The heterogeneity of COPD is underscored by the fact that smoking is a key precipitating factor but that the disease requires a complex interplay of extrinsic as well as intrinsic factors specific to a given person. We We seem seem to to have have become become fixated fixated with with this this simple simple paradigm paradigm that that smoking smoking causes causes inflammation inflammation causes causes airflow airflow obstruction obstruction causes causes COPD, COPD, and and that that is is not not right. right. COPD COPD is is a a number number of of different different diseases, diseases, so so we we need need to to have have research research into into the the different different paradigms. paradigms. If If you re you re looking looking at at emphysema, emphysema, for for example, example, the the treatment treatment for for emphysema emphysema will will be be very very different different from from the the treatment treatment for for COPD COPD and and chronic chronic bronchitis, bronchitis, so so I I would would encourage encourage people people to to try try and and break break the the COPD COPD mold mold and and look look at at the the subsets subsets within within that that blanket blanket definition. definition. It It served served its its purpose purpose very very well, well, but but it s it s now now time time to to move move beyond beyond that. that. Pulmonologist Pulmonologist COPD Patients 39% Current Smoker Non-smoker 30% 31% Former Smoker Center on an Aging Society analysis of data from the 1998 National Health Interview Survey. Defined Health - Pg. 25

26 Underlying Immunological Mechanisms Defined Health - Pg. 26

27 Asthma COPD Barnes PJ, Nature Reviews immunology vol 8, March 2008 Defined Health - Pg. 27

28 Similar Patterns of Inflammation in COPD & Severe Asthma The historical paradigm of developing symptomatic relief drugs for asthma and then expanding into COPD will become increasingly difficult in the coming years. Due to the genericization of the symptom relief market and drugs developed to address the pathophysiology of asthma may not be as effective in COPD as the cell types & mechanisms appear for the most part distinct between asthma and COPD. However, there are clearly points of intersection such as IL-13 and p38. Barnes PJ, Nature Reviews immunology vol 8, March 2008 Defined Health - Pg. 28

29 Current and Future Medical Needs Defined Health - Pg. 29

30 Current & Future Medical Needs Effective implementation of early smoking cessation education & treatment Easy to use devices and/or oral approaches to therapy Screening of patients with risk factors for COPD Earlier diagnosis of the disease not when symptoms are severe enough for patient to present to PCP Biomarkers to identify early disease and progression Finding disease modifying approaches Defined Health - Pg. 30

31 Regulatory & Trial Issues Defined Health - Pg. 31

32 Lung Function FEV 1 is the FDA accepted gold standard for diagnosis and staging Spirometry is the measuring tool for FEV 1 Currently the only accepted primary endpoint for efficacy of pharmacological development Other standards help to define respiratory failure, hyperinflation and dyspnea: Arterial Oxygen Tension (PaO2) and Arterial Carbon Dioxide Tension (useful outcomes in interventional studies that affect lung ventilation perfusion relationships) Lung Volume at rest or exercise (measured by more complicated equipment than spirometers) It has also been suggested that inspiratory capacity be used in the clinic in order to monitor hyperinflation changes which cannot be detected by spirometry Cazzola M. et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers Eur Respir J 2008 Defined Health - Pg. 32

33 Exacerbation Frequency and Severity Definition Four types of exacerbation are defined in the literature All types of exacerbations include any increase in respiratory symptoms over baseline A majority of patients are aware that an exacerbation is imminent and symptoms tend to be consistent from one to another Clinical trial significance Trials using exacerbation frequency tend to be longer than a year because seasonal variation (environmental) factors into the frequency of events However patient population is skewed toward patients that have 0-2 exacerbations a year as opposed to 10 or more Frequency and severity of these events tend to be monitored with patient diaries There are currently no biomarkers to measure risk or severity of exacerbation Cazzola M. et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers Eur Respir J 2008 Defined Health - Pg. 33

34 Mortality To date mortality is the most robust clinical outcome in COPD research All-cause mortality is used because most patients do not die from COPD, but instead a complication of the disease However all other variables aside from FEV 1 and Body Mass Index, Obstruction, Dyspnea, and Exercise endurance Index (BODE Index) have shown to be poor surrogates for predicting mortality Cazzola M. et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers Eur Respir J 2008 Defined Health - Pg. 34

35 Other Measures Quality of Life measure (QoL) Poor correlation between FEV 1 scores and QoL ratings Clinical trials tend to include QOL as a secondary endpoint in conjunction with FEV 1 scores Exercise Tolerance Differences in physiological response to these tests can show improvement in dyspnea and arterial oxygen saturation The 6 Minute Walk Test (6MWT) is a widely used as a secondary outcome measure to show benefits of pharmacological intervention Imaging Imaging is a hotly debated issue amongst clinicians over the past year The main problem of imaging for small airways in COPD patients is the lack of a validated methodology for performing the procedure and collecting the data Although it may show promise in detection of airway remodeling, it is a long way of from an acceptable trial endpoint Cazzola M. et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers Eur Respir J 2008 Defined Health - Pg. 35

36 FDA Guidance for Development Drug effect Primary Endpoint Trial Duration Comments Improve Airflow Obstruction Immediate change in FEV1 3 Months for bronchodilators 6 Months for nonbronchodilators Symptom Relief Reflect claimed clinical benefit Modify exacerbations Duration, severity, delay, and frequency should all be assessed Alter Disease Progression Change in FEV1 over time Modify Lung Structure Evidence that lung tissue has regenerated and is properly functioning 6 Months 1 Year 3 Years Several Years i.e. Reduced Cough must assess coughing subjectively or objectively Seasonal Dependence makes trial duration extended Cannot parallel disease progression after initial improvement Defined Health - Pg. 36

37 Potential Catalysts for COPD Drug Discovery and Development Defined Health - Pg. 37

38 Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) Sponsored by GSK, ECLIPSE planned to recruit 2,180 COPD subjects in Global Initiative for Chronic Obstructive Lung Disease categories II IV and 343 smoking and 223 nonsmoking control subjects. Study procedures are to be performed at baseline, 3 months, 6 months and every 6 months thereafter for 3 years. The study is expected to conclude 4Q09, however, GSK has started to publish early findings including preliminary studies of potential biomarkers for epithelial repair, COPD diagnosis and disease progression (CC-16), and exacerbation risk (SP-D). Clearly, ECLIPSE has the potential to shed some light on current problems faced by clinicians and drug developers by providing better tools for disease classification, prognostication, treatment selection, and drug screening/testing. It may also help to generate new drug development hypotheses and therapeutic targets. Eur Respir J Jan 22. [Epub ahead of print] ; Thorax 2008;63; ; Eur Respir J 2008; 31: Defined Health - Pg. 38 ECLIPSE Study Procedures

39 Network-Based Drug Discovery? The large-scale generation and integration of genomic, proteomic, signaling and metabolomic data are increasingly allowing the construction of complex networks that provide a new framework for understanding the molecular basis of physiological or pathophysiological states. Networkbased drug discovery aims to harness this knowledge to investigate and understand the impact of interventions, such as candidate drugs, on the molecular networks that define these states, Schadt, Friend, and Shaywitz (2009). Nat Rev Drug Discov Apr;8(4): Defined Health - Pg. 39

40 Future Approaches To Therapy Defined Health - Pg. 40

41 COPD & Asthma Development Pipeline PC I II III Prereg Reg Market COPD Only Asthma Only Both Asthma Both COPD Adis R&D Insight 6/2009 Defined Health - Pg. 41

42 COPD Pipeline - Active Life-cycle Management The development is focused on combinations of bronchodilators and corticosteroids, as well as ultra-long acting beta-agonists and anticholinergics. Mechanism PC PI PII PIII Prereg Reg Launched I-III LABA LAMA LABA/LAMA ICS LABA/ICS LAMA/ICS Adis R&D Insight 6/2009 Defined Health - Pg. 42

43 COPD Pipeline - Novel Anti-inflammatory Mechanisms Mechanism PC I II III Prereg Reg Launched I-III PDE4 inhibitors Prostaglandin D2 receptor antagonists Leukotriene antagonists IL-13 receptor antagonists Leukocyte elastase inhibitor Adenosine receptor antagonists p38 MAPK inhibitors CCR/CXCR antagonists TNF antagonists lipoxygenase inhibitors IL-8 (CXCR2) receptor antagonists MMP inhibitors Interferon stimulants PI3K inhibitors ADIS R&D Insight 6/2009 Defined Health - Pg. 43

44 Still Unproven Routes of Development Defined Health - Pg. 44

45 PDE-4 Inhibitor Multiple Pathway Approach Nature Reviews Drug Discovery, Oct 2004 Defined Health - Pg. 45

46 PDE-4 Inhibitors in Development Roflumilast (pre-registration EU, Phase III US Nycomed). Balanced PDE-4 D & B inhibition. Good anti-inflammatory but weak bronchodilating effects compared to theophylline Oral, QD dosing A study of 1440 moderate to severe COPD patients, demonstrated a therapeutic effect on FEV 1 (GOLD III& IV) and improvement in QoL and exacerbation frequency versus placebo (GOLD IV only) Use maybe with LABA s instead of ICS (that increase the risk of LRTI s) A number of other products in development Tetomilast (Phase II, Otsuka), Arofylline (Phase II, Almirall); GSK (Phase II, GSK Inhaled); Oglemilast (Phase II, Glenmark); GPD-1116 (Phase I, Biotie) Calverly PMA et al, Am J Respir Crit Care Med 2007, Adis R&D 6/2009 Defined Health - Pg. 46

47 TNF-α TNF-α has a principal role in lung inflammation maintains neutrophilic inflammation locally in airways and lung parenchyma and systemically by inflammatory weight loss Significantly higher levels of TNFα are found in people with COPD and weight loss compared to a matched population of healthy volunteers TNF levels inversely correlate to Pa02 and increased dyspnea severity Nature Reviews Drug Discovery, June 2002 Defined Health - Pg. 47

48 TNFα Early studies promoted by early preclinical data and empiric observation of improved outcome in rheumatoid arthritis patients with COPD treated by TNFα s halving of the hospitalization rate. Two products trialed in respiratory disease etanercept (Enbrel) and infliximab Etanercept has been evaluated more in severe asthma and infliximab in various severities of COPD In severe asthma etanercept or infliximab can improve respiratory symptoms and lung function, plus reduce exacerbations and airways inflammation on a short-term basis Infliximab given long-term has been shown to improve outcomes such as exercise capacity in younger and more cachetic subjects with more advanced disease TNFα safety concerns include serious infections Tuberculosis In the U.S. 144 TB cases in 100,000 patients ( ) were reported. 72% occurring 90 days after therapy is a reason for caution in the COPD population Suissa S. et al. Pulm Pharmacol Ther 2008, Wallis RS et al Clin Infect Dis 2004, Defined Health - Pg. 48

49 IL8 - CXCR2 and CXCR1 Antagonists While IL-8 has been the focus of many studies, other chemokine receptor ligands appear to be activated in COPD (CXCL1, CXCL5), and capable of modulating neutrophilic inflammation. Redundant signaling modalities may explain the disappointing failure of Abgenix s anti-il8 monoclonal antibody therapy in psoriasis and COPD. A few companies have now shifted there focus from ligand to the receptor. Schering-Plough has recently completed (4Q09) a phase II trial of its CXCR2 (SCH ), which represents the first true test of CXCR inhibition in COPD. The study results are highly anticipated. Ligand Pharmaceutical 8k Report (02/2009) Defined Health - Pg. 49

50 Old Drugs, New Strategies for COPD Defined Health - Pg. 50

51 Antibiotics Prophylactic Therapy for Prevention of Acute Exacerbations The vicious-circle hypothesis contends that microbial colonization is significant to the development of COPD exacerbations and progression. A recent study (109 pts) showed that daily intake of macrolide antibiotics (erythromycin) reduce exacerbation frequency by ~35% (moderate-to-severe COPD), suggesting that prophylactic antibiotic therapy may be used to disrupt the circle. Several larger studies are currently underway, with results expected later in 2009/2010. Bayer, Oral Moxifloxacin, Phase III NHLBI, Oral Azithromycin Mpex, Inhaled Levofloxacin, Phase II Am J Respir Crit Care Med Dec 1;178(11): Defined Health - Pg. 51

52 Theophylline Stimulation of HDAC Activity for the Reversal ICS Resistance There is mounting evidence that theophylline may reverse corticosteroid resistance through its action of HDAC2 expression, which has implications for the treatment of resistant asthma and COPD. Recently, a study of smoking asthmatics showed that the theophylline/ics combination improved symptoms and lung function to a greater extent than either single agent. Argenta Discovery is hoping to harness this synergy and improve theophylline s tolerability through the development of an inhaled theophylline/budesonide formulation (Phase I, EU). Thorax May;64(5): Epub 2009 Jan 21; Eur Respir J May;33(5): Epub 2009 Feb 5. Argetna Discovery Website Defined Health - Pg. 52

53 Statins - Pleiotropic Effects May Reduce COPD- Associated Morbidity and Mortality Statins have consistently been associated with reduce morbidity and mortality, although the clinical evidence is largely derived from retrospective analyses. They are believed to have antioxidant, anti-inflammatory, and immunomodulatory effects through the regulation of disease-associated cytokines, chemokines, and MMPs. Chest 2007;131; ; Chest Apr 17. [Epub ahead of print] Defined Health - Pg. 53

54 Potential Ways Forward? Defined Health - Pg. 54

55 Arachidonic Acid Metabolism Focus of development activity CysLT1 LTD 4 CysLT2 LTE 4 BLT1 Defined Health - Pg. 55 BLT2 Prostaglandins & other Lipid Mediators 2002

56 Arachidonic Acid Metabolism - Drugs in Development Efficacy? Phospholipase A2: liberates arachidonic acid from membrane phospholipids. Ph II: Asthma Ph II/III: Asthma, Atherosclerosis 5-Lipoxygenase: converts arachidonic acid into the unstable epoxide LTA4. Ph II: Asthma, COPD Leukotriene A4 Hydrolase: converts LTA4 into LTB4. PC: Asthma, atopic dermatitis, IBD Leukotriene C4 Synthase: converts LTA4 into LTC4. Adis R&D Insight Defined Health - Pg. 56 Safety?

57 PI3K Signaling in Steroid Resistance Theophylline is an old drug that resensitizes COPD patients to corticosteroids, but is seldom used anymore due to adverse effects. Recently, it has been shown that theophylline targets PI3Kδ, and that PI3K inhibitors can inhibit oxidative stressinduced reduction of HDAC2. Development of PI3Kδ-specific inhibitors, or inhibitors further downstream in the PI3K signaling pathway, could potentially yield a drug which has the efficacy of theophylline but not the side effects. Role of HDAC2 in the Pathophysiology of COPD Defined Health - Pg. 57

58 Conclusions COPD is a growing problem with a high rate of morbidity and mortality. Smoking cessation and Oxygen therapy are the only interventions with documented mortality benefit. Immunological pathways and their inter-relationships not fully understood. Novel approaches using these pathways not yet producing a major clinical benefit. A 3 product approach (ICS/LABA/LAMA) using established products will bring greater symptomatic relief but not be disease modifying. A QD dosage regimen will greatly help patients obtain the maximum benefit and compliance with therapy. A disease modifying agent is still the holy grail everyone seeks Defined Health - Pg. 58

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