Better Health, Brighter Future
Neuroscience Research & Development at Takeda
The Challenge of Neuropsychiatric Disorders
Neuropsychiatric disorders, affecting the central nervous system (CNS), are seen as one of the final frontiers of modern medicine. However, progress has been slow with drug development in the area declining since the 1990s due to fewer early-stage trials being started and a high attrition rate for neuropsychiatric medicines.1 With this high level of risk, many pharmaceutical companies have been discouraged from pursuing drug development in this area.
The unmet need is stark. More than one billion people worldwide suffer from neuropsychiatric diseases, with the incidence of neurological disorders growing faster than any other disease class in the US and the EU.1 However, while the number of people living with these conditions grows, clinical advances are not keeping pace.
“At a time when many companies are shifting their focus away from neuroscience, Takeda is accepting this challenge head-on," said Emiliangelo Ratti, Head of the Neuroscience Therapeutic Area. “As a core therapeutic area, our mission is to provide medicines for people with neuropsychiatric disorders for whom there are no treatments available. To do this, we are harnessing the latest scientific breakthroughs, innovative technologies, and external partnerships to discover and develop medicines for neuropsychiatric disorders associated with high unmet need.”
Neuropsychiatric disorders are complex multifaceted conditions that affect the spectrum of mental health. It is therefore vital that Takeda respects this multifaceted nature and take a patient-centric approach to neuroscience drug discovery and development.
Learning From the Past
A key aspect for Takeda has been looking at past failures and successes in neuroscience drug development and using this information to optimize research. Ratti notes that there are a number of aspects that can negatively impact neuroscience research. These include; drug targets being poorly related with the biology observed in patients, enrolled patient populations being too heterogeneous, inadequate measurement tools used for assessing changes in disease severity and drug effect, and clinical trial design and implementation being too complex and sub-optimal.
How is Takeda Addressing the Neuroscience Challenge?
These insights have provided Takeda with a foundation to build on our vision: to provide innovative medicines for targeted patient populations suffering from neuropsychiatric disorders for whom there are no treatments available.
5 Challenges of Takeda
Establishing an understanding of disease biology
Most neuropsychiatric disorders result from the converging effects of subtle genetic variants and environmental factors that act by modifying brain circuits. Takeda is investing in the identification of targets that have a strong association with neuropsychiatric disorders as assessed using bio samples and genetic analysis.
Importance of external partnerships
Partnership is integral in our drive to innovate for the benefit of people with neuropsychiatric disorders. Takeda collaborates with patients, academic institutions, pharmaceutical and biotechnology partners, payors, regulators and prescribers to accelerate understanding of neuropsychiatric disorders and help research and identify targets.
Identifying a homogeneous patient population for clinical trials
The complexity and variability of symptoms in neuropsychiatric disorders can make clinical trial recruitment difficult. Takeda conducts what we call “disorder deconstruction” to identify a sub-group of patients with a smaller cluster of symptoms that may have a greater probability to respond to a treatment.
Increasing precision and validity of clinical endpoints
Tools used in clinical trials to assess changes in neuropsychiatric disease severity, as well as to measure drug effect, were often inadequate. Takeda is aiming to use biomarkers to assess changes produced by an investigational treatment, acting as surrogate markers to provide precise information on drug-induced effects.
Using digital technology to address operational challenges
Recent developments of wearable devices that monitor movement, temperature, light and sounds may allow for the continuous symptom profiling of patients during clinical trials, providing more robust observations when compared with self-rated questionnaire or subjective scores.
What are neuropsychiatric disorders?
Neuropsychiatric disorders, those that affect the central nervous system (CNS), are common involving 25-30% of the population and include diseases such as Alzheimer's and Parkinson's diseases, major depression, and schizophrenia.
The CNS is made up of the brain, the spinal cord, and the optic nerves. The CNS controls thought processes, guides movement, and registers sensations throughout the body.
The CNS is considered separate from the peripheral nervous system (PNS), although the two systems are highly intertwined. The term PNS refers to any part of the nervous system that lies outside of the brain and spinal cord. A major difference between the CNS and PNS involves regeneration. The majority of the PNS has the ability to regenerate, whereas the CNS does not have this capability.
References
1.Kesselheim AS, et al. Two decades of new drug development for central nervous system disorders. Nature Reviews Drug Discovery. 2015 14, 815–816.