MediciNova (MNOV) Pops Higher Following Presentation of Significant MN-166 Phase Ib Data
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MediciNova, Inc. (Nasdaq: MNOV) is ticking higher Wednesday after the company announced the presentation of preliminary results from a Phase 1b study of MN-166 (ibudilast) in methamphetamine addiction at the 75th Annual Meeting of the College on Problems of Drug Dependence (CPDD) in San Diego on June 18, 2013. The company said that MN-166 was featured in both a poster session and a symposium at the meeting where leading researchers discussed the role of activated glia, and potential intervention with glial attenuators like MN-166, in drug abuse. Pre-clinical and early clinical results were summarized in the symposium session.
Shares are up 28.4 percent on the session.
"We are excited to present the results of our initial analyses of data from our trial showing MN-166 does not cause significant changes in cardiovascular functioning in the presence of relevant doses of methamphetamine in people living with methamphetamine addiction. We are additionally encouraged with the discussion at the symposium of the strong potential for glial attenuators, like MN-166, to provide a novel approach to fighting drug addictions," said Steven Shoptaw, Ph.D., Professor, UCLA Departments of Family Medicine and Psychiatry and Biobehavioral Sciences and principle investigator of the trial. "Methamphetamine is toxic to the brain. MN-166 may act by reducing methamphetamine's neurotoxic inflammation and attenuating other actions contributing to dependence."
"MN-166 is a novel and exciting approach to treating drug addiction," said co-investigator Keith Heinzerling, M.D., Assistant Professor, UCLA Department of Family Medicine, Medical Director, UCLA Center for Behavioral and Addiction Medicine. "We look forward to initiating later this summer a National Institute on Drug Abuse-funded Phase 2 trial of MN-166 for methamphetamine dependence."
Preliminary results from one cognitive performance task, presented in a poster session, showed significant improvement in measures of sustained attention in subjects completing a treatment sequence ending with a one-week course of MN-166 dosing at 100 mg/day versus those subjects completing the treatment sequence on an inactive control ("placebo"). In addition, MN-166 was featured in a symposium panel titled "Preclinical to Clinical Evidence that Glia and Neuroinflammation Mediate Drug Abuse and Related Pathologies on Tuesday, June 18 at 10:00 am Pacific. The panel included researchers from UCLA, Columbia University in New York, and Virginia Commonwealth University. In the symposium, Dr. Shoptaw summarized results of cardiovascular safety analyses wherein infusions of methamphetamine administered at placebo, 40 mg/day and 100 mg/day MN-166 regimens. Analyses showed that in the presence of relevant doses of methamphetamine, MN-166 produced no significant changes in blood pressure or heart rate. These cardiovascular safety interaction endpoints were a primary objective in the study design. He also noted that MN-166 administration did not result in any serious or severe adverse events, or subject discontinuations due to adverse events. These findings provide support for moving forward with the Phase 2 trial.
"We are very pleased with the continuing safety data for MN-166 and look forward to advancing our program, focusing on drug addiction indications as well as progressive multiple sclerosis," said Dr. Yuichi Iwaki, President and CEO of MediciNova. "Congratulations to Drs. Shoptaw and Heinzerling on their unwavering efforts to test pharmacotherapies for this devastating disease."
Shares are up 28.4 percent on the session.
"We are excited to present the results of our initial analyses of data from our trial showing MN-166 does not cause significant changes in cardiovascular functioning in the presence of relevant doses of methamphetamine in people living with methamphetamine addiction. We are additionally encouraged with the discussion at the symposium of the strong potential for glial attenuators, like MN-166, to provide a novel approach to fighting drug addictions," said Steven Shoptaw, Ph.D., Professor, UCLA Departments of Family Medicine and Psychiatry and Biobehavioral Sciences and principle investigator of the trial. "Methamphetamine is toxic to the brain. MN-166 may act by reducing methamphetamine's neurotoxic inflammation and attenuating other actions contributing to dependence."
"MN-166 is a novel and exciting approach to treating drug addiction," said co-investigator Keith Heinzerling, M.D., Assistant Professor, UCLA Department of Family Medicine, Medical Director, UCLA Center for Behavioral and Addiction Medicine. "We look forward to initiating later this summer a National Institute on Drug Abuse-funded Phase 2 trial of MN-166 for methamphetamine dependence."
Preliminary results from one cognitive performance task, presented in a poster session, showed significant improvement in measures of sustained attention in subjects completing a treatment sequence ending with a one-week course of MN-166 dosing at 100 mg/day versus those subjects completing the treatment sequence on an inactive control ("placebo"). In addition, MN-166 was featured in a symposium panel titled "Preclinical to Clinical Evidence that Glia and Neuroinflammation Mediate Drug Abuse and Related Pathologies on Tuesday, June 18 at 10:00 am Pacific. The panel included researchers from UCLA, Columbia University in New York, and Virginia Commonwealth University. In the symposium, Dr. Shoptaw summarized results of cardiovascular safety analyses wherein infusions of methamphetamine administered at placebo, 40 mg/day and 100 mg/day MN-166 regimens. Analyses showed that in the presence of relevant doses of methamphetamine, MN-166 produced no significant changes in blood pressure or heart rate. These cardiovascular safety interaction endpoints were a primary objective in the study design. He also noted that MN-166 administration did not result in any serious or severe adverse events, or subject discontinuations due to adverse events. These findings provide support for moving forward with the Phase 2 trial.
"We are very pleased with the continuing safety data for MN-166 and look forward to advancing our program, focusing on drug addiction indications as well as progressive multiple sclerosis," said Dr. Yuichi Iwaki, President and CEO of MediciNova. "Congratulations to Drs. Shoptaw and Heinzerling on their unwavering efforts to test pharmacotherapies for this devastating disease."
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