Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (October 2014)
18 slides from Medicinova's investor presentation, Oct 17, 2014
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 Progressive MS, ALS, and Drug Dependence Two large Phase 2b studies ongoing (Progressive MS and methamphetamine) Initiated clinical development in ALS in 2014 Patents co
Slide 4: MediciNova: Active Programs in Clinical Development in Sep. 2013
MediciNova: Active Programs in Clinical Development in Sep. 2013 Active Programs as of September 2013
Slide 5: MediciNova: Active Programs in Clinical Development in Oct. 2014
MediciNova: Active Programs in Clinical Development in Oct. 2014
Slide 6: 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, we
Slide 7: IPF 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 Digestiv
Slide 8: Tipelukast (MN-001) and Ibudilast (MN-166)
Tipelukast Ibudilast MN-001 Developing Novel Therapeutics… MEDIC I NOVA MN-166
Slide 9: 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 PDE Inhibition: • Increases cAMP, reducing inflammation MIF inhibition • Linked to attenuated disease progression in animal models of MS How does MN-166 w
Slide 10: MN-166 Phase 2 RRMS Data: What Do the Data Show?
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) • Significant improvement in time to first relapse
Slide 11: 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 12: 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 13: 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 14: Tipelukast: What Do the Data Show?
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 reductio
Slide 15: Progressive MS: Next Steps
Progressive Multiple Sclerosis “Progressive MS” Next Steps – Progressive MS Q2 2013: Submit New IND Amendment and New Ph2 Protocol Q3 2013: FDA approval & Study Initiation Q3 2013: Screening begins Q4 2013: First Patient In Q1 2015: Last Patient In Q1 2017: Last Patient Out 1H 2017: Results availabl
Slide 16: ALS: Next Steps
Amyotrophic Lateral Sclerosis (ALS) “Lou Gehrig's Disease” Next Steps - ALS Q3 2014: Submit New ALS Protocol as IND Amendment Q3 2014: FDA Approval to Start Study Q3 2014: IRB Submission & Site Activation Q3 2014: Study Start-up & Database Build Q4 2014: Began Enrollment TBD: Last Patient In
Slide 17: NASH Tipelukast: Next Steps
Nonalcoholic Steatohepatitis (NASH) Tipelukast Next Steps - NASH Q1 2014: Positive preclinical data in NASH Q3 2014: Positive preclinical data in Advanced NASH Q3 2014: Prepare IND submission Q4 2014: Present NASH data at JDDW ASAP: Submit IND and Protocol MN-001
Slide 18: MN-166 Ibudilast and Tipelukast MN-001 Timeline Summary
MN-166 Ibudilast Tipelukast MN-001 Timeline Summary MEDIC I NOVA