MN-166 Data
Posted: Wed Oct 29, 2008 2:17 pm
I found this on the ECTRIMS website. Not sure if it has already been posted:
Cyclops
Clinical effect of the neuroprotectant MN-166 in relapsing multiple sclerosis: year 2 data
R. Gammans1; F. Barkhof2; J. Drulovic3
1. Development, MediciNova, San Diego, CA, USA.
2. VUMC, Amsterdam, Netherlands.
3. Institue of Neurology, Belgrade, Serbia.
MN-166 (ibudilast) is an orally administered small molecule with neuroprotectant and anti-inflammatory properties. In year 1 of this 2-year study (Drulovic et al., ECTRIMS 2008), MN-166 at 60mg/day significantly reduced percent brain volume (PBV) loss and prolonged time-to-first relapse by 157 days (p=0.04), but did not significantly reduce cumulative new lesion count, the primary study endpoint, in relapsing–remitting multiple sclerosis (RRMS) patients. MN-166 produced a dose-related reduction in change of new inflammatory lesions to PBH (p=0.01; Gammans et al., ENS 2008).
To evaluate the clinical effects and safety of MN-166 in RMS patients over 2 years.
RRMS (93%) or SPMS with relapses (7%) patients and ≧ 1 T1 Gd-lesion were randomized to placebo (PBO, n=100) or MN-166 at 30 (n=94) or 60mg/day (n=98); for year 2 PBO patients were pre-assigned to MN-166 at 30 (n=49) or 60mg/day (n=51). Clinical and magnetic resonance imaging (MRI) evaluations were every 2 months for 2 years.
Two hundred and sixty four (96% of PBO - 30mg/day, 97% of PBO - 60mg/day, 82% of 30mg/day and 87% of 60mg/day) patients entered year 2. Significantly fewer patients treated with MN-166 for 2 years at 30 or 60mg/day than patients treated with PBO followed by MN-166 at either dose for 1 year had a sustained disability progression (+1 point on Extended Disability Status Scale – EDSS – for >=4 months) (2 year MN-166 10.4%, PBO to MN-166 21%, p=0.03). MN-166 at 60mg/day for 2 years significantly (p=0.04) attenuated loss in PBV compared with the remaining groups. MN-166 was well tolerated at either dose. Three of 85 MN-166 60mg/day patients discontinued in year 2 for adverse effects compared with none in the other groups. Only GI events were more frequent in year 2 on MN-166 at 60mg/day (11%) and 30mg/day (4.2%) PBO-to-60mg/day (2%) PBO-to-30mg/day (0%). Depression was reported in 5% of the 60mg/day and 3% of the PBO-to-60mg/day patients towards the end of the second year of the study.
The findings in this 2-year study on three independent measures – reduced disability progression (50%), reduced conversion of inflammatory lesions to PBH (37%) and reduced PBV loss – suggest that MN-166’s clinical benefit results predominantly from protecting neurons from damage. These data suggest that MN-166 reduces progression of MS.
Cyclops
Clinical effect of the neuroprotectant MN-166 in relapsing multiple sclerosis: year 2 data
R. Gammans1; F. Barkhof2; J. Drulovic3
1. Development, MediciNova, San Diego, CA, USA.
2. VUMC, Amsterdam, Netherlands.
3. Institue of Neurology, Belgrade, Serbia.
MN-166 (ibudilast) is an orally administered small molecule with neuroprotectant and anti-inflammatory properties. In year 1 of this 2-year study (Drulovic et al., ECTRIMS 2008), MN-166 at 60mg/day significantly reduced percent brain volume (PBV) loss and prolonged time-to-first relapse by 157 days (p=0.04), but did not significantly reduce cumulative new lesion count, the primary study endpoint, in relapsing–remitting multiple sclerosis (RRMS) patients. MN-166 produced a dose-related reduction in change of new inflammatory lesions to PBH (p=0.01; Gammans et al., ENS 2008).
To evaluate the clinical effects and safety of MN-166 in RMS patients over 2 years.
RRMS (93%) or SPMS with relapses (7%) patients and ≧ 1 T1 Gd-lesion were randomized to placebo (PBO, n=100) or MN-166 at 30 (n=94) or 60mg/day (n=98); for year 2 PBO patients were pre-assigned to MN-166 at 30 (n=49) or 60mg/day (n=51). Clinical and magnetic resonance imaging (MRI) evaluations were every 2 months for 2 years.
Two hundred and sixty four (96% of PBO - 30mg/day, 97% of PBO - 60mg/day, 82% of 30mg/day and 87% of 60mg/day) patients entered year 2. Significantly fewer patients treated with MN-166 for 2 years at 30 or 60mg/day than patients treated with PBO followed by MN-166 at either dose for 1 year had a sustained disability progression (+1 point on Extended Disability Status Scale – EDSS – for >=4 months) (2 year MN-166 10.4%, PBO to MN-166 21%, p=0.03). MN-166 at 60mg/day for 2 years significantly (p=0.04) attenuated loss in PBV compared with the remaining groups. MN-166 was well tolerated at either dose. Three of 85 MN-166 60mg/day patients discontinued in year 2 for adverse effects compared with none in the other groups. Only GI events were more frequent in year 2 on MN-166 at 60mg/day (11%) and 30mg/day (4.2%) PBO-to-60mg/day (2%) PBO-to-30mg/day (0%). Depression was reported in 5% of the 60mg/day and 3% of the PBO-to-60mg/day patients towards the end of the second year of the study.
The findings in this 2-year study on three independent measures – reduced disability progression (50%), reduced conversion of inflammatory lesions to PBH (37%) and reduced PBV loss – suggest that MN-166’s clinical benefit results predominantly from protecting neurons from damage. These data suggest that MN-166 reduces progression of MS.