Close

Medicinova (MNOV) Announces Positive Phase 2 Trial MN-166 Data Published in the American Journal of Drug and Alcohol Abuse

December 6, 2022 6:29 AM EST

Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.

MediciNova, Inc. (NASDAQ: MNOV) announced that positive results from a secondary analysis of a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in The American Journal of Drug and Alcohol Abuse.

The clinical trial was a collaborative effort between MediciNova and Dr. Lara Ray, Professor, Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at the University of California at Los Angeles (UCLA) and was funded by the National Institute on Drug Abuse (Grant P50 DA005010-33). Topline results from a randomized, double-blind, placebo-controlled Phase 2 trial evaluating the effect of 14 days of ibudilast treatment on mood, heavy drinking, and neural reward signals in 52 non-treatment seeking individuals with AUD found that MN-166 (ibudilast) reduced heavy drinking and attenuated neural cue-reactivity compared to placebo (Grodin et al, Transl Psychiatry, 2021).

Neural and peripheral inflammation has been implicated in the development and maintenance of AUD, as evidenced by increased inflammation in such individuals. A secondary analysis of this study was performed to determine if participants with elevated peripheral levels of proinflammatory proteins, specifically C-reactive protein (CRP), would show a greater benefit from MN-166 (ibudilast) as assessed by clinical (drinks per drinking day, or DPDD; percent heavy drinking days, or PHDD) and biological (cue-elicited neural activation) outcomes.

The publication, entitled, “Baseline C-reactive protein levels are predictive of treatment response to a neuroimmune modulator in individuals with an alcohol use disorder: a preliminary study,” was authored by Dr. Lara Ray and colleagues at UCLA.

Key results reported in the publication are as follows:

  • Participants with high baseline CRP, i.e., high inflammation, had higher baseline DPDD and PHDD relative to the low baseline CRP group.
  • The high baseline CRP group who received MN-166 (ibudilast) had significantly fewer DPDD compared to the low baseline CRP group (p = 0.007) who received MN-166 (ibudilast).
  • No significant differences on DPDD were found between any other groups (p’s >0.17).
  • There was also a significant interaction between MN-166 (ibudilast) and continuous log CRP levels on DPDD (p = 0.03).
  • The low baseline CRP group treated with MN-166 (ibudilast) had greater alcohol cue-elicited activation (i.e. reward signaling) in several brain regions relative to the high baseline CRP group treated with MN-166 (ibudilast) (p <0.001).
  • The high baseline CRP group treated with placebo had greater alcohol cue-elicited activation in several brain regions relative to the high baseline CRP group treated with MN-166 (ibudilast) (p <0.001).
  • The high baseline CRP group treated with placebo had greater alcohol cue-elicited activation in several brain regions relative to the low baseline CRP group treated with placebo (p <0.001).

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, “We are very pleased that this secondary analysis of the results of this Phase 2 trial in alcohol use disorder have been published. We are thrilled that MN-166 appeared to show great potential clinical utility in individuals with an AUD who also have elevated inflammation, thereby increasing the probability of successful outcomes in the treatment of AUD.”

Professor Lara Ray commented, “Results from this Phase 2 clinical trial reinforce the theory that inflammation plays a role in the effect of MN-166 (ibudilast) treatment on alcohol consumption, implying that individuals with elevated baseline CRP levels benefitted the most from MN-166 (ibudilast) as shown by lower DPDD, PHDD, and lower alcohol cue-elicited activation.”



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA

Related Entities

FDA