Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (September 2015)
21 slides from Medicinova's investor presentation, Sep 25, 2015
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
Novel product candidates in clinical development with encouraging efficacy and safety data MN-166 (ibudilast) for the treatment of Neurology Diseases including Progressive MS, ALS, and Drug Dependence Approved in Japan in 1989 (post-stroke dizziness and asthma) Large safety database MN-001 for the t
Slide 4: MediciNova: Active Programs in Clinical Development
MediciNova: Active Programs in Clinical Development
Slide 5: Progressive MS and ALS: Neurodegenerative Diseases
Progressive Multiple Sclerosis “Progressive MS” Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig's Disease” Neurodegenerative Diseases MS affects more than 400,000 people in the U.S. and 2.3 million worldwide Patients experience a diminished quality of life (e.g. fatigue, walking difficulties, weakne
Slide 6: Idiopathic Pulmonary Fibrosis and NASH: Fibrotic Diseases
Idiopathic Pulmonary Fibrosis “IPF” Nonalcoholic Steatohepatitis “NASH” Fibrotic Diseases NASH prevalence in the U.S. is 2-5% Additional 10-20% have “fatty liver” due to being overweight or obese NASH Market forecast: $1.6 billion by Approved Drugs: NO TREATMENT APPROVED 1. National Digestive Diseas
Slide 7: Tipelukast (MN-001) and Ibudilast (MN-166)
Tipelukast Ibudilast MN-001 Developing Novel Therapeutics… MEDIC I NOVA MN-166
Slide 8: Glial Cell Attenuation: How does MN-166 work?
GLIAL CELL ATTENUATION Role of Glia: Type of macrophage Increases in number during brain damage Glial activation leads to neurodegeneration MIF Inhibition: Linked to attenuated disease progression in animal models of MS PDE inhibition Increases cAMP, reducing inflammation How does MN-166 work?
Slide 9: MN-166: MS Data
MN-166 Phase 2 RRMS Data Significant attenuation of brain volume loss (p=0.035) Significant attenuation of conversion of acute lesions to persistent black holes (p=0.004) Sustained disability progression was significantly less likely (p=0.026) MN-166 Ongoing NIH-funded Phase 2b study PPMS and SPMS s
Slide 10: MN-166: Addiction Data
MN-166 Opioid Withdrawal & Analgesia Phase 1b/2a Trial Reduced Subjective Opioid Withdrawal Scale (SOWS) Significantly reduced perspiring (p<0.05) and hot flashes (p<0.05), two components of SOWS MN-166 Opioid Self-Administration Phase 2a Trial (INTERIM DATA) Significantly decreased the craving for
Slide 11: MN-166: Krabbe Disease
FDA Granted Orphan Drug Designation to MN-166 for Krabbe disease (June 2015) Krabbe disease is a rare genetic degenerative disorder for which there is no cure and is generally fatal before two years of age Only treatment option for Krabbe disease is hematopoietic stem cell transplantation, which has
Slide 12: What is Fibrosis?
What is Fibrosis? Fibrosis Fibrosis is the development of excess fibrous connective tissue in an organ Fibrosis is a result of inflammation, irritation, or healing (e.g. scar) Cross-linking of collagen and elastin is the final step in fibrosis Cross-linking of collagen and elastin fibrosis
Slide 13: How does Fibrosis Develop?
How does Fibrosis Develop? Genes Promoting Fibrosis LOXL2 Collagen Type 1 CCR2 MCP-1 TIMP-1 LOXL2 Cross-linking of collagen and elastin fibrosis Collagen Type 1 CCR2 MCP-1 TIMP-1
Slide 14: Tipelukast: How does MN-001 work?
Tipelukast How does MN-001 work? MN-001 MN-001 LOXL2 Cross-linking of collagen and elastin fibrosis Collagen Type 1 CCR2 MCP-1 TIMP-1 MN-001 Reduces Gene Expression LOXL2 Collagen Type 1 CCR2 MCP-1 TIMP-1
Slide 15: Tipelukast: MN-001 Data
Tipelukast More than 600 human subjects exposed to MN-001 Phase 2 study of MN-001 in asthma with positive results MN-001 was considered generally safe and well-tolerated Pre-clinical data shows anti- fibrotic effect in a Dose- Dependent Manner Improved NAFLD Activity Score (NAS) via a reduction in h
Slide 16: Timeline - Progressive MS
Progressive Multiple Sclerosis “Progressive MS” Timeline - Progressive MS Q2 2013: Submit New IND Amendment and New Protocol Q3 2013: FDA Approval of Protocol & Study Initiation Q4 2013: Began Enrollment Q2 2015: Presentation at AAN Q2 2015: Completed Enrollment 2H 2016: Interim analysis 1H 2017: Fi
Slide 17: Timeline - ALS
Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig's Disease” Timeline - ALS Q3 2014: Submit New ALS Protocol as IND Amendment Q3 2014: FDA Approval to Start Study Q4 2014: Began Enrollment Q2 2015: Presentation at AAN: Positive Interim Safety Review Q3 2015: Amended Protocol to include 60 Advanced ALS
Slide 18: Timeline - NASH
Nonalcoholic Steatohepatitis (NASH) Tipelukast Timeline - NASH MN-001 Q1 2014: Positive preclinical data in NASH Q3 2014: Positive preclinical data in Advanced NASH Q4 2014: Present NASH data at AASLD and JDDW Q1 2015: Opened IND; FDA Approved Phase 2 Protocol Q1 2015: New Patent allowed for NASH Q2
Slide 19: Timeline - IPF
Tipelukast Idiopathic Pulmonary Fibrosis “IPF” Timeline - IPF Q2 2014: Positive preclinical data in pulmonary fibrosis Q3 2014: Present data at ICLAF Q4 2014: Prepare Protocol Q4 2014: FDA granted Orphan-drug designation to MN-001 for IPF Q1 2015: FDA Approved Phase 2 Protocol for moderate to severe
Slide 20: MN-001 (tipelukast): New Patents
MN-001 (tipelukast): 3 New Patents NASH: New Patent covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for treatment of nonalcoholic steatohepatitis (NASH); Expires no earlier than Dec 2032 NAFLD: New P atent covers MN - 001 (tipelukast) and MN - 002 (a major metabolite of MN - 001
Slide 21: Timeline Summary
• ALS: New Protocol Submitted • ALS: FDA Approval to Start Study • ALS: Began Enrollment • NASH: Positive Preclinical Data • NASH: Presented at AASLD and JDDW • IPF: Orphan Drug Designation Granted • New Patents cover NAFLD, steatosis, and other liver disorders • Progressive MS: Interim Analysis MN-