MN-221, a Novel Beta2-Adrenergic Agonist for Treatment of Acute Asthma and COPD
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1 MN-221, a Novel Beta2-Adrenergic Agonist for Treatment of Acute Asthma and COPD Brian M. Sadler PhD, Alan Dunton MD, Ernest Kitt, James Bosley PhD, Ron Beaver PhD November 2010 MediciNova, Inc. Rosa & Co. LLC Copyright 2010 Rosa and Co. LLC, all rights reserved, used by permission.
2 The prevalence of both asthma and COPD are increasing in the US. 2 million annual emergency room visits for acute asthma in US. ~500,000 annual hospitalizations Average length of stay for asthma hospitalization is 3.2 days Average cost for asthma hospitalization is $6, million adults had a diagnosis of COPD in the US in 2000: 119,000 deaths, 726,000 hospitalizations, and 1.5 million ER Standard of care includes ß2-agonists, anticholinergics, oral and systemic steroids Sources: National Center for Health Statistics/CDC, American Lung Association. Page 2
3 MN-221 is an i.v.-administered highly-selective β-agonist intended for use in the emergency room. A well-tolerated, potent, selective β2-agonist which is only a partial agonist at β1. A bronchodilating duration of action that is longer than SABAs and shorter than LABAs. Provides additional bronchodilation when used in addition to the standard treatments of inhaled albuterol, inhaled ipratropium, and steroids. MN-221 Indication: Treatment of bronchospasms in patients with acute exacerbations of asthma or COPD. It is administered adjunctive to standard of care by intravenous infusion. Page 3
4 MN-221Differentiation: β 2 -agonist product profiles Drug β 2 Potency β 2 Selectivity* β 2 Agonism β 1 Agonism Duration of Action Albuterol + + Partial Full Short Terbutaline + + Partial Full Short MN Full Partial Medium Salmeterol Partial Partial Long Formoterol Full Full Long * Selectivity of MN-221 vs other receptors >250X Source: Study Numbers KUR-PC J12, Cerep (2008), Cerep (2007); Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients, Palmqvist M, Ibsen T, Mellen A, Lotvall J, AM J RESPIR CRIT CARE MED 1999;160: Page 4
5 Avoiding ambiguity in trials of β-agonists is difficult. Quantifying SOC/MN SOC differences may be impossible using simple statistics Critical outcome measurements, such as FEV1, are highly variable. Disease pathology ensures that there will be non-responders. β 1 and β 2 agonists affect heart and lung, and the relative strength of effect varies. Deviations from drug delivery protocol are common in emergency department trials. MediciNova chose to use modeling & simulation to clearly show MN-221 advantages. Page 5
6 MN-221 phase 1 clinical trials in Asthma and COPD MN-221-CL-004 Study MN-221-CL-006 Study MN-221-CL-010 Study MN-221-CL-005 Study MN-221-CL-007 Study Stable Asthma Patients Acute Asthma Patients Stable COPD Patients Albuterol Responders Albuterol Nonresponders Albuterol Responders 6 Page 6
7 A single model of MN-221 can represent PK in either COPD or Asthma CL-010 PK model, 600 mg dose CL-010 PK model, 1200 mg dose MN-221 in Plasma (ug/l) MN-221 in Plasma (ug/l) Time (hr) Time (hr) Parameter CL-010 (η) CL-005 (η) CL (L/hr) 24.5 (0.011) 27.0 (0.008) V1 (L) 17.9 (0.21) 17.0 (0.165) Q2 (L/hr) 16.1 (0.23) 18.3 (0.15) V2 (L) 184 (0.36) 155 (0.14) Q3 (L/hr) 17.5 (0.08) 20.8 (0.06) V3 (L) 19.9 (0.04) 22.3 (0.04) A 1,200 μg dose of MN-221 was selected for COPD and asthma patients. Page 7
8 MN-221 concentration and FEV 1 improvement are well represented by an E MAX model coupled to the PK model. CL-004 PK and PD predictions vs. time from PopPK/PD model PopPK model structure Concentration (ug/l) Effect C3 C2 Plasma Time (hr) FEV1 1 IV dose C 1 Plasma K Clearance K 13 K 21 K 31 K 12 C 3 C 2 Peripheral compartments PD (FEV1) Model FEV1 is well correlated to the peripheral (not plasma) concentration. Page 8
9 Administration of albuterol in the SOC was handled by adapting the MN-221 model to include albuterol as a competitive agonist. MN-221 Albuterol Plasma C 3 Peripheral compartments Inhaled dose F Plasma IV dose C 1 Clearance C 2 PD (FEV1) Model for coadministration C 2A Lung tissue compartment C 1A Clearance FEV 1 = E 0 + EC 50 E + max C 2 C C E + max C 2 A 2 A 2 A 2 1 C2 EC50 A EC A EC50 C C C 2 A This structure accounted properly for both competitive binding and potency (Emax) differences. Page 9
10 A clinically significant MN-221 response above and beyond SOC was shown using a poppk/pd mixture model. CL006 trial Data and Model All Subjects 80 FEV-1 (% Predicted) SOC+MN-221 responders SOC-only responders Non-responders Time relative to start of infusion (hr) Clinically and statistically significant change in FEV1 at low dose. The estimated probability of being a responder is ~78%. Non-responders are algorithmically chosen. Page 10
11 A model representing the effect of MN-221 on heart rate predicted no MN-221-induced tachycardia. MN-221 Model IV dose Heart Rate = HR E C max,1 1 max, ε1 EC50,1 + C1 EC50,2 + C1 E C Plasma C 1 C 3 Baseline β1 effect β2 effect Clearance C 2 Peripheral compartments CL-004 Observed vs. Predicted HR Residual error shows no trends or bias. Page 11
12 QT interval trial data show no indication of dose-related QT prolongation. QTcF at 2 hours post-dose, by dose group. QTcF at 5 hours post-dose, by dose group. 2 hours post dose 5 hours post dose QTcF (milliseconds) QTcF (milliseconds) Dose of MN-221 Dose of MN-221 MN-221 shows no significant heart rate-adjusted QT interval increase. Page 12
13 MN-221 may reduce the hospitalization rate in acute asthmatics. Fraction of subjects hospitalized by dose (sample size shown) Page 13
14 Summary MN-221 shows a clinically relevant FEV1 improvement above SOC. Responders (to β-agonists) comprise about 78% of the target population. There were no safety concerns with adding MN-221 to SOC. No MN-221 dose-related QT prolongation or Tachycardia PK/PD modeling gave key insights into drug action, safety, and effect. Pharmacokinetics of MN-221 are well characterized by a 3-compartment model. Pharmacokinetics of MN-221 are nearly identical in COPD patients and asthma patients. Data support the 1200 µg dose (or higher) in both COPD and asthma. There was a potential reduction in the hospitalization rate among patients treated with MN-221. MN-221 may have significant benefits in other indications and routes of administration (i.e. inhalers for asthma and COPD, preterm labor). Page 14
15 Acknowledgments MediciNova Kirk Johnson, PhD Alan Dunton MD Maria Feldman Carol Conlin RN Mark Munsey Kazuko Matsuda MD Rosa & Co LLC Brian M. Sadler PhD James Bosley PhD Ron Beaver PhD SAB Richard Novak MD Rob Silverman MD Page 15
16 MN-221, a Novel Beta2-Adrenergic Agonist for Treatment of Acute Asthma and COPD Brian M. Sadler PhD, Alan Dunton MD, Ernest Kitt, James Bosley PhD, Ron Beaver PhD November 2010 MediciNova, Inc. Rosa & Co. LLC
17 MediciNova Contact - Partnering Geoffrey O Brien Director, Business Development MediciNova, Inc La Jolla Village Drive, Suite 950 San Diego, CA (858) obrien@medicinova.com 17 Page 17
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