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For the treatment of Major Depressive Disorder

MIN-117, our antidepressant drug candidate, has a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporter. We are developing MIN-117 to address unmet medical needs in patients suffering from MDD and presenting with anxio-depressive symptoms.

Patients suffering from MDD experience feelings of sadness, loss, anger or frustration that interfere with their ability to carry out and enjoy once-pleasurable activities. While suicide is the leading cause of death in those with MDD, other factors, such as changes in immune function and susceptibility to disease, can also lead to early mortality.

We believe MIN-117 has the potential to address limitations of existing therapies, such as slow onset of action and poor safety and tolerability, without many of the typical side effects associated with currently approved therapies. The pharmacological effects of MIN-117 are related to serotonin and dopamine, two neurotransmitters in the brain. MIN-117 is meant to block a specific subtype of serotonin receptor called 5-HT1A. When 5-HT1A is blocked, anxiety and mood can be regulated.

In addition, MIN-117 is meant to prevent the reuptake of serotonin and dopamine, which increases the amount of serotonin and dopamine in the brain, which is tied to an improvement in mood in individuals suffering from MDD. MIN-117 is also meant to modulate the levels of Alpha-1a and 1b, which further modulates serotonin and dopamine.

Recent Developments and Next Steps

In May 2016, we announced top line results from a Phase IIa clinical trial in MDD with MIN-117. Results demonstrated dose-dependent superiority of MIN-117 over placebo as measured by change in the Montgomery-Asberg Depression Rating Scale, or MADRS. Data show that MIN-117 at the 0.5 mg daily dose had an effect size (magnitude of difference) as compared to the placebo group of 0.24 while the 2.5 mg daily dose had an effect size of 0.34. This magnitude of effect size is similar to those observed with currently marketed antidepressants. Improvement in MADRS with MIN-117 against placebo was observed at two weeks. Furthermore, data also show that 24% of the patients treated with 2.5 mg of MIN-117 achieved remission as prospectively defined. Both doses of MIN-117 demonstrated a favorable tolerability profile, and the incidence and types of side effects did not differ significantly between the MIN-117 group and the placebo group. No unexpected adverse events were reported. Preliminary analysis shows that treatment with MIN-117 is not associated with cognitive impairment, sexual dysfunction, suicidal ideation or weight gain.

A Phase 2b clinical trial with this compound is underway. The trial is recruiting adults with a diagnosis of moderate or severe MDD with anxious distress without psychotic features.

Learn more about major depressive disorder.