Benzinga | Nov 25, 2020 06:32AM EST

MediciNova Highlights Publication Of SPRINT-MS Phase 2b Trial Of MN-166 Trial In Multiple Sclerosis Journal

LA JOLLA, Calif., Nov. 25, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) were published in Multiple Sclerosis Journal. OCT was a secondary outcome measure in the SPRINT-MS trial.



The publication, entitled "Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis", is a report of the OCT results of the SPRINT-MS trial. The authors include Robert A. Bermel and Robert J. Fox, both from the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, and several others. The authors conclude that retinal thinning in MS may be attenuated by MN-166 (ibudilast) and that sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect.

Of the 28 sites participating in the SPRINT-MS trial, 22 sites used Zeiss Cirrus OCT and 6 sites used Heidelberg Spectralis OCT. This resulted in 183 participants imaged with Cirrus and 61 participants imaged with Spectralis.

All OCT measures showed less loss of retinal tissue for MN-166 (ibudilast) compared to placebo. Key results reported in the publication include the following:

* Change in pRNFL (peripapillary retinal nerve fiber layer) thickness was +0.0424 uM/year for MN166 (ibudilast) versus ?0.2630 uM/year for placebo (n = 244, p = 0.22).

* Macular volume change was ?0.00503 mm3/year for MN-166 (ibudilast) versus ?0.03659 mm3/year for placebo in the Spectralis cohort (n = 61, p = 0.044).

* For the Cirrus cohort, macular volume change was ?0.00040 mm3/year for MN-166 (ibudilast) compared to ?0.02083 mm3/year for placebo (n = 183, p = 0.1734).

* Ganglion cell-inner plexiform (GCIP) layer thickness change, available from Cirrus, was ?0.4893 uM/year for MN-166 (ibudilast) versus ?0.9587 uM/year for placebo (n = 183, p = 0.12).

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are very pleased that the positive OCT data has been published. This data demonstrates that MN-166 can reduce retinal thinning in progressive MS patients and is further evidence of its neuroprotective effect as retinal thinning is associated with brain volume loss and other measures of MS progression."