Minerva Neurosciences today filed to raise $69 million via an initial public offering (IPO).  The proceeds from this fund raising will be used to further develop and test their new drug candidates that are targeted at schizophrenia, depression and other mental illnesses.  We at schizophrenia.com think that its great to see new medications being developed that target schizophrenia’s negative and cognitive symptoms and it bodes well for the future of people who have schizophrenia.  This is just one of many new medications under development for schizophrenia.  This new schizophrenia-targeted medication by Minerva Neuroscience is currently identified as “MIN-101” and the detailed description of this new medication is included below, as from their IPO S1 filing. For more information (or, for example, to get in on clinical trials of their new medications) contact Minerva Neurosciences, Inc. (http://minervaneurosciences.com).

MIN-101 – A new medication for the Treatment of Schizophrenia

Minverva Neurosciences is developing the first lead product candidate, MIN-101, an innovative antagonist on 5-HT2A and sigma2 receptors, for the treatment of patients affected by schizophrenia. The pharmacological effects of MIN-101 are caused by MIN-101 blocking serotonin receptors and sigma receptors, two receptors in the brain that regulate mood and anxiety. MIN-101 is meant to block a specific subtype of serotonin receptor called 5-HT2A. When 5-HT2A is blocked, certain symptoms of schizophrenia (in particular positive symptoms) and side effects of antipsychotic treatments can be minimized. Additionally, blocking 5-HT2A promotes slow wave sleep, a sleep stage which is often disrupted in patients with schizophrenia. MIN-101 is also meant to block a specific subtype of sigma receptor called sigma2, which is involved in movement control, psychotic symptom control and learning and memory. Blocking sigma2 also modulates other neurotransmitters in the brain, in particular dopamine. Individuals with schizophrenia often have elevated levels of dopamine in their brains. Blocking sigma2 also increases calcium levels in neurons in the brain, which can improve memory. Patients suffering from schizophrenia suffer from one or more of the following:

• Positive Symptoms — such as delusions, hallucinations, thought disorders and agitation; 

 

• Negative Symptoms — such as mood flatness, lack of pleasure in daily life, or decreased ability to initiate and maintain social interaction; 

 

• Cognitive Symptoms — such as decreased ability to understand information and make decisions, difficulty focusing and decreased working memory function; or 

 

• Sleep Disorders — such as difficulty falling asleep, staying asleep or poor sleep quality.

According to Datamonitor, 4.2 million patients suffered from schizophrenia in 2012 in the United States and the five major European Union markets, and the number of patients is expected to steadily increase in line with population growth. Patients with predominantly negative symptoms represented 48% of the overall patient population in 2012 within the United States and the five major European Union markets. In addition, 80% of the overall patient population in 2012 within the United States and the five major European Union markets suffered from cognitive impairment. Further, approximately half of the number of patients with schizophrenia experience sleep disorders, which further exacerbates positive and negative symptoms of schizophrenia.

Positive symptoms are often experienced only periodically in an individual with schizophrenia while negative symptoms persist chronically throughout an individual’s lifetime and increase with severity over time. Patients with negative symptoms typically have a projected outcome that is worse than those suffering from positive symptoms, particularly those with persistent chronic negative symptoms. This is mainly because patients suffering from negative symptoms often do not even recognize that they have an illness and, therefore, do not seek treatment. Even when they do seek treatment, the disease is difficult to diagnose and currently available treatments generally are unable to improve negative symptoms and may exacerbate negative symptoms.

There are many therapies currently approved for the treatment of schizophrenia. However, most current therapies are geared primarily towards treating positive symptoms and there are no current treatments specifically approved for the treatment of negative or cognitive symptoms. Approved treatments generally result in significant side effects, including sedation, involuntary movements, prolactin increase, metabolic syndrome, cognitive impairment, sleep disorders and weight gain. These side effects and the lack of efficacy on negative and cognitive symptoms contribute to a high rate of treatment discontinuation of between 60% to 80% over the course of 18 months, according to Datamonitor.

Unlike current therapies, Minverva Neurosciences believes MIN-101, at the anticipated dose and dosing schedule, due to its particular pharmacological profile, has the potential to address negative symptoms as well as the positive and cognitive symptoms of the disease, sleep and overall psychopathology, without many of the typical side effects of existing approved therapies, such as involuntary movements, prolactin increase, sedation, sleep disorders, weight gain and metabolic syndrome. We intend to seek approval for MIN-101 initially as a first line monotherapy and also plan to study its use as an adjunctive therapy. We believe that MIN-101 could address the existing treated population and those who are not being treated successfully with the currently available therapies. In a Phase IIa clinical trial, a statistically significant improvement of negative symptoms and a non-statistically significant trend toward the improvement of positive and cognitive symptoms, and overall psychopathology was observed after three months of administration of MIN-101. The trial also showed that MIN-101 could have sleep promoting effects, in contrast to currently available therapies with no negative effects on sleep as measured by polysomnography. We plan to initiate a small clinical trial in the second quarter of 2014 to confirm earlier Phase I results, using a once a day formulation, in preparation for conducting a Phase IIb trial of MIN-101 in the second half of 2014 in Europe. We also plan to investigate the effects on sleep, cognition, anxiety and mood, as well as clinical and biological safety and drug plasma levels.