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Drug Development

Coordination of Drug Development

ReqMed is offering a new drug development model "Coordination-type Drug Development", beyond simple consultation and parallel with licensing activities, we support drug development in Japan and Asia. By conducting early clinical studies in conjunction with our strategic partners, including academic institutions and CROs, our licensing clients can save more than 2 years in the development of their products.
*POC: Proof of Concept. Proof of pharmaceutical action in patients.


Our Project

Pentosan Polysulfate

Pentosan Polysulfate is the semi-synthetic compound derived from plant and has effect to alleviate pain symptoms of osteoarthritis by its multiple pharmacological activities on articular tissue.

Indication: Osteoarthritis [Phase IIa – Ongoing]



Osteoarthritis

Osteoarthritis is a condition in which low-grade local inflammation results in pain in the joints, joint deformation, and limited joint movement caused by wearing of the cartilage that covers and acts as a cushion inside joints. As the bone surfaces become less well protected by cartilage, the patient suffers from pain upon weight bearing, including walking and standing. An epidemiological survey by Tokyo University reported that osteoarthritis affects nearly 75% of women over 50 years old and 53% of men over 50 years old in Japan. Unfortunately, it is impossible to completely repair a damaged knee joint. With the help of medication, degeneration can be slowed and your quality of life can be improved.

Pentosan Polysulfate is a medical product which is manufactured by bene pharmaChem GmbH (Munich, Germany). This product has already been approved and marketed as an anti-coagulant agent in Europe and as a drug for interstitial cystitis in the US. Several clinical researches, including that conducted by the Pentosan Research Group, whose representative is Professor Masami Niwa, Faculty of Medicine, Nagasaki University, showed efficacy of pentosan in osteoarthritis patients. ReqMed and bene pharmaChem jointly started collaboration of development of pentosan targeting to osteoarthritis indication in 2004. After ReqMed completed two Phase I studies in Japan, the companies licensed Asahi Kasei Pharma for further development of pentosan for osteoarthritis field in June 2008. Asahi Kasei Pharma announced in May 2010 that they started Phase IIa study in Japan.

Bene pharma Chem
Asahi Kasei Pharma Corporation





Eltoprazine

Eltoprazine is a low molecule chemical compound which is a Serotonin 1A/1B (5-HT1A/1B) partial receptor agonist and showed efficacy on several CNS-disease animal model.

Indication:
Attention-Deficit Hyperactivity Disorder [Phase IIa – Completed]
Cognitive Impairment Associated with Schizophrenia [Phase IIa – Start in 1Q/2011]
Dyskinesia Associated with Parkinson Disease [Phase IIa – Start in 4Q/2010]



Attention-Deficit Hyperactivity Disorder (AD/HD)

Attention-Deficit Hyperactivity Disorder (AD/HD) and Attention-Deficit Disorder (ADD) are mental disorders that become apparent in some children by age 7. It is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. The disorder has been long recognized in the United States where aggressive treatment is offered. In Japan, only limited treatment is currently available.

PsychoGenics discovered a promising compound, eltoprazine, as a non-stimulant drug for the treatment of ADHD/ADD using unique AD/HD mouse model, Coloboma mice. ReqMed is jointly developing this compound with PsychoGenics. The Phase IIa study conducted by PsychoGenics demonstrated the efficacy and tolerability in the adult AD/HD patients. Even though some therapeutic drugs for AD/HD have been marketed and developed in Japan, we believe that giving a new option will be helpful for both children and adults suffering from AD/HD and ADD.



Cognitive Impairment Associated with Schizophrenia (CIAS)

Schizophrenia is a mental disorder characterized by a disintegration of the process of thinking and of emotional responsiveness with a global lifetime prevalence of around 1.5%. It most commonly manifests as the following symptoms.


Positive symptoms: delusions, auditory hallucinations, and thought disorder

Negative symptoms:flat or blunted affect and emotion, poverty of speech (alogia), inability to experience pleasure (anhedonia), lack of desire to form relationships (asociality), and lack of motivation (avolition)

Cognitive Impairment:lack or impairment of ability in speed of processing, attention/vigilance, working memory, verbal learning and memory, visual learning and memory, reasoning and problem solving, and social cognition

The drugs for the treatment of schizophrenia are mainly focusing on improvement of positive and negative symptoms. No drug targeting CIAS has been developed so far.

Since the National Institute of Mental Health, which is part of the National Institutes of Health (NIH), a component of the U.S. Department of Health and Human Services, recognizes necessity of medicines for the treatment of CIAS, the MATRICS identified the key cognitive domains for schizophrenia by NIH budget. Now, they are evaluating the several antipsychotic agents for the CIAS treatment using MATRICS Battery (TURNS project). Because PsychoGenics had data of effectiveness on enhancement of cognitive faculty in an animal model, eltoprazine was applied to this program and adopted to this program. An clinical study in the TURNS project is planned to start in the 1st Quarter of 2011.

*: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) (www.matrics.ucla.edu)
**:Treatment Units for Research on Neurocognition and Schizophrenia (TURNS) (www.turns.ucla.edu)



Dyskinesia associated with Parkinson Disease

Parkinson disease is a progressive degenerative disorder of the central nervous system that impairs motor skills such as tremor at rest, stiffness, slowing of movement and postural instability, and also cognitive processes, and other functions. Symptoms of Parkinson disease result from insufficient formation and action of dopamine produced in the dopaminergic neurons of the midbrain, specifically the substantia nigra. Prevalence of this disease in Japan is 0.1 to 0.15%.

Dyskinesia is a movement disorder which consists of effects including diminished voluntary movements and the presence of involuntary movements, similar to tics or chorea. Dyskinesia occurring in patients with Parkinson disease is caused by long term use of levodopa preparations which has been the most widely used treatment of the Parkinson disease for long time. Motor fluctuations appear 50% of patients who are treated with levodopa preparations for 5 to 10 years. Such percentage of patients who develop dyskinesia increases according to duration of levodopa treatment.

It has been known that serotonin (5-HT) receptors are crucial to motor control in health and disease*, **. Eltoprazine is a 5-HT1A/1B partial receptor agonist and showed inhibition of L-dopa-induced dyskinesia in an animal model. PsychoGenics started the clinical study to confirm efficacy of eltoprazine on dyskinesia, a kind of POC study, in the 4th Quarter of 2010, under the grant from the Michael J. Fox Foundation which is established by US actor Michael J. Fox in 2000.

*: Carta et al., Brain 130: 1819-1833, 2007
**: Carta et al., Brain 132: 319-335, 2009





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