Minerva Neurosciences Screens First Patient in Phase 2b Trial of MIN-117 to Treat Major Depressive Disorder
The primary objective of the trial is to evaluate the efficacy of two fixed doses of MIN-117, 5.0 milligrams (mg) and 2.5 mg, compared with placebo in reducing the symptoms of major depression as measured by the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score over six weeks of treatment. Secondary objectives include: (1) assessment of the change from baseline in symptoms of anxiety using the Hamilton Anxiety Scale (HAM-A); (2) the change in severity of illness using the Clinical Global Impression of Severity Scale (CGI-S) and Clinical Global Impression of Improvement Scale (CGI-I); and (3) safety over six weeks of treatment.
“While existing therapies for MDD are available, their effectiveness is limited due to unacceptable side effects, particularly cognitive impairment and sexual dysfunction,” said Dr.
The study population will consist of adults with a diagnosis of moderate or severe MDD with anxious distress and without psychotic features. Based upon previous clinical observations, the Company believes that patients with MDD who also have symptoms of anxiety may benefit from treatment with MIN-117.
Approximately 324 patients are expected to be enrolled at approximately 40 sites in the U.S. and Europe. Patients will be randomized to one of three arms, including placebo and the two dosage arms, in a 2:1:1 ratio, resulting in approximately 162 patients in the placebo group and 81 patients in each of the two MIN-117 treatment groups. The study design includes a screening phase of up to three weeks, a six-week double-blind treatment phase and a two-week post-study follow-up period. Top line results of the trial are expected in the first half of 2019.
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.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with MIN-117; the timing and scope of future clinical trials and results of clinical trials with this compound; the clinical and therapeutic potential of this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-117 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the
VP, Investor Relations/
Source: Minerva Neurosciences, Inc