Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (July 2013)
32 slides from Medicinova's investor presentation, Jul 17, 2013
Slide 1: Developing Novel Therapeutics for the Treatment of Serious Diseases with Unmet Medical Needs
Developing Novel Therapeutics for the Treatment of Serious Diseases with Unmet Medical Needs Exhibit 99.1
Slide 2: Forward-looking statements
Statements in this presentation that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding MediciNova’s clinical trials
Slide 3: MediciNova Highlights
Two novel product candidates in clinical development, both with encouraging efficacy and safety data MN-166 (ibudilast) for the treatment of drug addiction & progressive MS Licensed from Kyorin Pharmaceuticals Two Phase 2 studies (methamphetamine and opioid addiction) Two progressive MS trials (pend
Slide 4: MediciNova: Active Programs in Clinical Development
MediciNova: Active Programs in Clinical Development
Slide 5: MN-221 (bedoradrine): A Novel Intravenous Treatment for Acute Exacerbations of Asthma
MN-221 (bedoradrine): MN-221 (bedoradrine): A Novel Intravenous Treatment for A Novel Intravenous Treatment for Acute Exacerbations of Asthma Acute Exacerbations of Asthma
Slide 6: MN-221 (bedoradrine) Overview
NCE (new chemical entity), small molecule, beta -adrenergic receptor agonist in iv form In development for the treatment of Acute Exacerbations of Asthma (AEA) adjunctive to standard of care Licensed from Kissei Pharmaceutical Co., Ltd. Completed four Phase 2 clinical trials in asthma or AEA and two
Slide 7: MN-221 (bedoradrine) Overview: Acute Asthma Treatment Flow in Emergency Departments
MN-221 (bedoradrine) Overview Acute Asthma Treatment Flow in Emergency Departments in the U.S. Source: National Center for Health Statistics / CDC, National Hospital Discharge Survey
Slide 8: Next Steps for MN-221
1. API Manufacturing requirements of FDA Kissei, our API supplier, is addressing requirements Approximately 6-month duration 2. Clinical development work including: Dose regimen optimization Revision and validation of acute asthma exacerbation trial • Primary endpoint will include hospitalization, c
Slide 9: MN-221: Impact of Dose Timing
MN-221: Impact of Dose Timing Note: Treatment Failure is hospitalization or return ER visit due to asthma. Times are time difference between steroid dose and study drug. Data is from Phase 2b trial of MN-221 in acute exacerbations of asthma. Based on Phase 2b data, the ideal time to administer MN-22
Slide 10: MN-166 (ibudilast): A Novel Oral Therapy for Methamphetamine and Opioid Addiction
MN-166 (ibudilast): MN-166 (ibudilast): A Novel Oral Therapy for the A Novel Oral Therapy for the Treatment of Methamphetamine and Treatment of Methamphetamine and Opioid Addiction Opioid Addiction
Slide 11: MN-166 (ibudilast) Overview
Non-addictive, orally-administered small molecule NCE in U.S. and Europe: NCE exclusivity / Data exclusivity Large safety database with over 3.2M patient exposures in Japan Primary use is in cerebrovascular disorders (post-stroke dizziness) Pharmacokinetics (PK) enable once or twice daily dosing Uni
Slide 12: MN-166 (ibudilast) Target Action - Molecular
ibudilast MN-166 (ibudilast) Target Action - Molecular MIF (macrophage migration inhibitory factor) PDE – 10, PDE – ibudilast pro-inflammation via CD74/CXCR2,4 receptors degradation of cAMP (& cGMP)
Slide 13: MN-166 (ibudilast) Target Action - Cellular
ibudilast MN-166 (ibudilast) Target Action - Cellular Withdrawal symptoms, drug-seeking and relapse associated with drug addiction; Neuropathology in drug addiction & progressive MS ibudilast An umbrella of cellular action covering the disease indications… PDE 4 , 10 MIF Silence Activated Glia & int
Slide 14: MN-166 Methamphetamine Phase 1b Trial
Trial Design Partners Status: Completed MN-166 (ibudilast)-Methamphetamine (MA) Phase 1b Trial n = 11 Non-treatment seeking MA dependent subjects Double-blind, placebo-controlled ~1 month inpatient hospitalization Dosing: One week each of Placebo, 40 mg/day, 100 mg/day Safety/Efficacy Measurements:
Slide 15: MN-166 Methamphetamine Phase 1b Trial: Safety
MN-166 (ibudilast)-Methamphetamine Phase 1b Trial Data presented at Annual CPDD Meeting in June 2013 Safety: Phase 1b trial established safety of co-administration of methamphetamine and MN-166 (ibudilast) in doses up to 100 mg/day Enables 100 mg/day dosing for Phase 2 outpatient trials
Slide 16: MN-166 Methamphetamine Phase 1b Trial: Efficacy
MN-166 (ibudilast)-Methamphetamine Phase 1b Trial p=0.01 Efficacy: Conner’s Continuous Performance Test-II (CPT-II) is a measure of sustained attention MN-166 (ibudilast) significantly reduced perseverations and variability in response times MN-166 (ibudilast) may have a protective effect on sustain
Slide 17: MN-166 Phase 2 Trial for Methamphetamine Addiction
Trial Design Partners Timing MN-166 (ibudilast) Phase 2 Trial for Methamphetamine Addiction n = 140 (seek to increase to 160) Treatment-seeking volunteers Randomized, double-blind, placebo-controlled 1:1 Randomization with placebo or 100 mg/day of MN-166 (ibudilast) 12-week outpatient study Primary
Slide 18: MN-166 Phase 1b/2a Trial: Opioid Withdrawal & Analgesia
Trial Design Partners Status: Completed MN-166 (ibudilast) Phase 1b/2a Trial: Opioid Withdrawal & Analgesia n = 30 Heroin-dependent subjects; 3-week inpatient setting Double-blind, placebo-controlled Week One: All subjects on morphine (30 mg/day) and Placebo Week Two: All subjects on morphine (30 mg
Slide 19: Ibudilast Effect on Primary Outcome - Subjective Opioid Withdrawal Scale
MN-166 (ibudilast) Phase 1b/2a Trial: Ibudilast Effect on Primary Outcome - Subjective Opioid Withdrawal Scale (SOWS) Individual Measurements of SOWS Composite Primary Endpoint = Total SOWS score as a function of ibudilast dose Opioid-related pupil constriction was greater in the 80 mg/day ibudilast
Slide 20: MN-166 Phase 2a Trial: Oxycodone Self-Administration in Opioid Abusers
Trial Design Partners Timing MN-166 (ibudilast) Phase 2a Trial: Effects of MN- 166 (ibudilast) on Oxycodone Self-Administration in Opioid Abusers n = 24 Prescription opioid drug abusers (including OxyContin, Vicodin, Percocet) or heroin Randomized, placebo-controlled, double-blind Inpatient study; t
Slide 21: Addiction Competitive Landscape
Addiction Competitive Landscape No pharmaceutical treatment approved for methamphetamine addiction Available therapeutics for treating opioid addiction have limited efficacy and face increasing clinical-regulatory scrutiny Buprenorphine & buprenorphine/naloxone combination (Subutex & Suboxone): Pote
Slide 22: US Methamphetamine Addiction Market
US Methamphetamine Addiction Market US Market Opportunity of Methamphetamine Addiction (1) (1) Dr. Phil Skolnick, Director, Division of Pharmacotherapies & Medical Consequences of Drug Abuse, NIDA; NSDUH survey; Neuropsychiatric R&D Conference, San Francisco, CA. September 2012 ~353,000 individuals
Slide 23: US Opioid Addiction Market
US Opioid Addiction Market US Market Opportunity for Opioid Addiction (1) Reckitt Benckiser Annual Report, 2012; Assumes 1 £ = 1.55 USD (2) Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National Survey on Drug Use and Health Current market for opioid addiction is well-est
Slide 24: MN-166 (ibudilast): A Novel Oral Therapy for Progressive Multiple Sclerosis
MN-166 (ibudilast): MN-166 (ibudilast): A Novel Oral Therapy A Novel Oral Therapy for the Treatment of for the Treatment of Progressive Multiple Sclerosis (MS) Progressive Multiple Sclerosis (MS)
Slide 25: MN-166 (ibudilast): The Promise in Progressive MS
MN-166 (ibudilast): The Promise in Progressive MS MN-166 (ibudilast) is a small molecule with established safety 297-patient, two-year Phase 2 clinical trial completed in MS • Significant dose-related improvements in disability progression and MRI outcomes (whole brain atrophy, black-hole formation)
Slide 26: MN-166 (ibudilast) Phase 2 Multiple Sclerosis Trial
MN-166 (ibudilast) Phase 2 Multiple Sclerosis Trial
Slide 27: MN-166 Phase 2 MS Trial: Whole Brain Atrophy Endpoint
Placebo 30 mg/day Low Dose Group 60 mg/day High Dose Group Patient Subset % Brain Volume Change % Brain Volume Change Magnitude of Effect % Brain Volume Change Magnitude of Effect RRMS -1.2 -1.1 8% less -0.8 33% less** SPMS -1.0 -0.7 30% less -0.44 56% less MN-166 (ibudilast) Phase 2 Multiple Sclero
Slide 28: MN-166 Phase 2 MS Trial: Grant Funding for Phase 2b
Placebo 30 mg/day Low Dose Group 60 mg/day High Dose Group Patient Subset % Brain Volume Change % Brain Volume Change Magnitude of Effect % Brain Volume Change Magnitude of Effect RRMS -1.2 -1.1 8% less -0.8 33% less** SPMS -1.0 -0.7 30% less -0.44 56% less MediciNova is pursuing grant funding to su
Slide 29: MN-166 (ibudilast) Clinical Trials
MN-166 (ibudilast) Clinical Trials MN-166 (ibudilast) is advancing in multiple Phase 2 programs GRANT-FUNDED CLINICAL DEVELOPMENT MODEL
Slide 30: Key Milestones for 2013-2014
Clinical Milestones Timing Key Milestones for 2013-2014 MAJOR NEAR TERM VALUE INFLECTION POINTS 2H:2013 2H:2013 2H:2013 2H:2014 Results of Phase 1b UCLA methamphetamine trial 1H:2013 Commence Phase 2 UCLA methamphetamine trial Announce grant funding for Phase 2b trial treating progressive MS with ib
Slide 31: MN-166 (ibudilast) Program Patents
Patent Exclusivity Patent Exclusivity MN-166 (ibudilast) Program Patents * U.S. patent expiration does not include Waxman-Hatch patent term restoration (industry average = 4.5 years) Method of Use Composition of Matter Addiction US Exp. EU Exp. 2026 AV1013 US Exp. EU Pending Progressive Multiple Scl
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