development status

        

Our Challenges on Mental Health



As society becomes more complicated, many people live with stress. Medical treatment for mental illnesses is not sufficient compared to physical illnesses. In particular, mental care for children and women is an important social issue.

We are working on the development of new drugs for socially urgent mental illnesses such as autism spectrum disease in children, premenstrual depression in women (premenstrual syndrome / premenstrual dysphoric disorder) and schizophrenia.



■ Our challenges to develop drugs for anxiety and stress (medical issues and needs)

"Neurotransmitters" are circulating in our brains when we feel emotions and think about various things. Neurotransmitters are secreted from the parts (synapses) that connect nerve cells and transmit information to other nerve cells. There are various types of neurotransmitters; among them, substances having an amino group are called monoamines in the brain. Typical examples are γ-aminobutyric acid (GABA), which has an anti-stress effect, serotonin, which provides mental stability, and dopamine, which increases motivation and euphoria. Reduction of the monoamines in the brain are known to be related to the development of mental disorders such as autism spectrum disease, premenstrual dysphoric disorder/premenstrual syndrome, and schizophrenia.


■ Drugs under development (treatment ideas and concepts)

RS8001 (pyridoxamine), which we are developing, is a type of vitamin B6. It is a water-soluble vitamin and a safe compound. Pyridoxamine has not been approved in developed countries including Japan. In our experiments, chemical reactions and animal studies revealed that pyridoxamine improves GABA and serotonin production and metabolism, leading to an increase in these neurotransmitters in the brain. Indeed, animals (rats) given pyridoxamine have proven to have become stable to excitement and stimuli (stress).


We are currently conducting, placebo controlled, multicenter, investigator initiated clinical trials on three different mental illnesses.


□ Autism spectrum disease

Autism spectrum disease is a developmental disorder characterized by poor personal relationships and strong commitment. In some patients, the sensations become very sensitive, causing great inconvenience in life (hyperesthesia). For example, they become very sensitive to certain sounds (acoustic hyperesthesia) or they become extremely difficult to wear clothes with a specific feel (tactile sensitivity) or they become very sensitive to light such as bright outdoors (visual hypersensitivity).

We are currently conducting a phase 2, placebo-controlled, multicenter, investigator initiated clinical trial in cooperation with 13 medical institutions such as Tohoku University and Osaka City General Medical Center.


□ Premenstrual syndrome/Premenstrual dysphoric disorder

They are disorders that cause discomfort from a few days before the onset of menstruation and recover just before or after menstruation. Emotional symptoms (sudden sadness, anger, depressed mood and despair), behavioral symptoms (less interest in work, school, hobbies, etc.), and physical symptoms (feel heavy, tired, overeating, hypersomnia, insomnia, etc.).

We are currently preparing for a phase 2, placebo-controlled, multicenter, investigator initiated clinical trial in cooperation with medical institutions such as Tohoku University, Kinki University, Tokyo Medical and Dental University, and Tokyo Women's Medical University. We plan to initiate the study by early 2021.


□ Schizophrenia

Patients with schizophrenia are associated with symptoms such as hallucinations and delusions. They are impaired in the ability to live at home and in the society while interacting with people (life disturbance), and they become difficult to look back and think for themselves about the fact that senses, thoughts, and behaviors are distorted by the illness (disability of insight).

An early phase 2a study (investigators initiated clinical trial) at Matsuzawa Hospital has been completed. A placebo-controlled, multicenter, phase 2b study is being conducted by the licensee; Kowa Company Ltd.