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For the treatment of Insomnia and Mood Disorders

MIN-202 is an innovative selective orexin 2 receptor antagonist under development for the treatment of insomnia and related mood disorders. Insomnia is the repeated difficulty with sleep initiation, maintenance or quality that occurs despite adequate time and opportunity for sleep, resulting in daytime impairment. Insomnia can be the primary condition for patients or a secondary symptom of, and contributor to, another medical or psychiatric condition, such as mood disorders or schizophrenia.

In the brain, the orexin system is involved in the control of several key functions, including metabolism and wakefulness. MIN-202 seeks to inhibit the activity of the neurons that promote wakefulness by selectively blocking the orexin 2 receptor. Rather than making an individual sleepier, blocking the orexin 2 receptor reduces the level of the neurotransmitters that signal the brain to maintain vigilance and wakefulness, which can be helpful for patients with insomnia. In addition, we believe this approach may help preserve physiologic and restorative sleep, with improved safety and tolerability over current treatments. Recent research also shows that the orexin system affects the secretion and control of stress hormones like the ones involved in the hypothalamic-pituitary-adrenal or HPA axis (e.g., adrenocorticotropic hormone and cortisol). The HPA axis is known to be overactive in depressed patients a significant proportion of whom suffer from insomnia. We are jointly developing MIN-202 under a co-development and license agreement with Janssen Pharmaceutica N.V., a Johnson & Johnson company.

Recent Developments and Next Steps

In January 2016, we announced top line results from a Phase IIa clinical trial of MIN-202 for the treatment of insomnia disorder. The trial was a randomized, two way, cross-over, placebo-controlled double-blind study to evaluate the effect of MIN-202 on sleep and daytime functioning in 28 patients with insomnia disorder without psychiatric co-morbidity. Patients were given MIN-202 or placebo in a cross-over design for treatment periods of five days, separated by a washout period. The trial was conducted at clinical sites in the United States and Europe.

Patients treated with MIN-202 in the trial were observed to have statistically significant improvements in key sleep parameters, compared to patients treated with placebo. These parameters include sleep efficiency as measured by objective polysomnography, the primary endpoint of the trial, for which a positive efficacy signal was observed with a 40 milligram dose of MIN-202 versus placebo (p<0.001). Additional significant positive efficacy signals were observed for key secondary parameters, including latency to persistent sleep, wake after sleep onset, and total sleep time. No serious adverse events were observed in this trial, and preliminary data indicate that MIN-202 was well tolerated by patients. The most common treatment-emergent adverse events associated with exposure to MIN-202 during the double-blind phase of the study were somnolence and abnormal dreams.

In March 2016, we announced top line results from a Phase Ib clinical trial in MDD with MIN-202. MIN-202 was observed to result in consistent improvements in the symptoms of depression in MDD patients in this trial. MIN-202 was observed to be well tolerated by study participants over a one-month treatment duration, with no new emerging safety signals and no serious adverse events.

The next steps in the development of MIN-202 include the initiation of three Phase 2b trials in the second half of 2017. These will include two trials in comorbid insomnia in patients suffering from depressive disorders and one in insomnia without neuro-psychiatric comorbid symptoms.

Learn more about insomnia and mood disorders.

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