Slide 1: MN-166 Reduces Conversion of New Lesions to Persistent Black Holes in Multiple Sclerosis Patients
Exhibit 99.1 MN-166 Reduces Conversion of New Lesions to Persistent Black Holes in Multiple Sclerosis Patients R. Gammans PhD, F. Barkof MD PhD, H. Hulst MD, R. Landin PhD for the MN-166-CL-001 investigators © MediciNova, Inc. 2008
Slide 2: Forward-Looking Statements
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, without limitation,
Slide 3: MN-166 CL-001 Investigators
MN-166 CL-001 Investigators • Serbia • Bulgaria – Congor Nad, MD PhD • Penko Shotekov, MD Dsci – Slobodan Vojinovic, MD PhD • Lyubomir Haralanov, MD PhD – Evica Dincic, MD PhD • Ivan G. Milanov MD PhD DSci – Jelena Drulovic, MD PhD • Ekaterina Titianova MD PhD – Branislava Mršulja, MD PhD • Study co
Slide 4: MN-166 (ibudilast) Mechanism(s) of Action
MN-166 (ibudilast) Mechanism(s) of Action • Anti-inflammatory • Neuroprotective – Phosphodiesterase 3A, 4, 10, 11 – Inhibits nitric oxide and inhibitor reactive oxygen species – Leukotriene inhibitor production – Inhibits Th1 cytokine production – Stimulates neurotrophic factor (IFN-, TNF- , IL-1, I
Slide 5: MN-166 CL-001 Scheme
MN-166 CL-001 Scheme (MRI and Clinical evaluations bi-monthly) 0-12 Month 12-24 Month 967 Patients 60 mg/d Screened Placebo N=100 30 mg/d 297 RMS 30 mg/d Patients N=94 30 mg/d Randomized 60 mg/d 60 mg/d N=98 Primary endpoint : cumulative active lesions by MRI Secondary endpoints: clinical relapses a
Slide 6: Main Year 1 Study Findings
Main Year 1 Study Findings (ECTRIMS 2007) • MN-166 was well tolerated at doses up to 60 mg/d • MN-166 treatment at a dose of 60 mg/d did not significantly reduce Cumulative Lesion Count (-18%, NS), the Primary Study Endpoint • MN-166 treatment at a dose 60 mg/d significantly prolonged time- to-first
Slide 7: Hypothesis and Objective
Hypothesis and Objective • Hypothesis: Based on its modest effect on inflammatory lesion count, its pharmacology, attenuating brain volume loss, and early trend to reduce sustained disability progression we hypothesized that MN-166’s clinical benefit at 60 mg/d may result primarily from protecting n
Slide 8: Methods
Methods Evolution of new lesions to Persistent Black Holes (PBH) or Recovered Lesions (RL) • Blinded MRI data from year 1 was evaluated by a new rater not previously involved in the study • New T1 gadolinium-enhancing or new T2 lesions were identified as NL (new lesions) in the first on-study drug M
Slide 9: Example of RL (red box)
Example of RL (red box) T1 with gadolinium T1 without gadolinium T1 without gadolinium T1 without gadolinium Visit 4 Visit 4 Visit 5 Visit 8 Month 2 Month 4 Month 10 © MediciNova, Inc. 2008
Slide 10: Assessment of Recovering Lesions
Assessment of Recovering Lesions Treatment Groups Parameter Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 2 72 64 56 # Patients with1=Recovering Lesion 42 (58.3%) 40 (62.5%) 34 (60.7%) Mean Proportion of Recovering Lesions 0.24 0.28 0.26 Median Proportion of Recovering Lesions 0.20
Slide 11: Persistent Black Hole – Axonal Loss
Persistent Black Hole – Axonal Loss T1 with gadolinium T1 without T1 without T1 without Visit 4 gadolinium gadolinium gadolinium Visit 4 Visit 5 Visit 8 Month 2 Month 4 Month 10 © MediciNova, Inc. 2008
Slide 12: Reduction of Persistent Black Hole (PBH) Formation
Reduction of Persistent Black Hole (PBH) Formation Treatment Groups Parameter Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 2 72 64 56 # Patients w. = 1 PBH (% of Pts. w. New 41 (56.9%) 33 (51.6%) 28 (50%) Lesions) Mean Proportion of Lesions Evolving to PBH 0.24 0.20 0.16 Median Pro
Slide 13: Summary
Summary • MN-166 had no effect on RL lesion evolution as defined in this study • MN-166 treatment reduced the Relative Risk that a new inflammatory lesion would evolve to a PBH • At 60 mg/d the RR was reduced to 0.63, a 37% reduction, p=0.011 • At 30 mg/d the RR was reduced to 0.74, a 26% reduction,
Slide 14: Conclusions
Conclusions • The findings of this investigation suggest that the main effect of MN-166 treatment in Relapsing MS patients is to protect neurons from the persistent damage that results form inflammatory lesions • Further study of the effect of MN-166 on sustained disability progression including mar