I am Mitsuo Kawato, the President of XNef, Inc.
There has been no major progress in psychiatry for 30 years, and psychiatric disorders are at the top of the DALY (*1) list. This is largely because diagnosis is based on subjective evaluation of symptoms alone. This non-objective approach does not allow quantitative assessment of patient conditions. Worse still, treatment is generally biased toward medications, even though life-long drug treatment is ineffective for most patients. There have been no mega-blockbuster drugs in the last three decades.
Advances in treatments have been stymied by the inability to objectively identify patients for whom a drug is effective. Drug discovery "clinical trials" (*2) often recruit different types of patients for targeted diseases. Many clinical trials fail due to this failure to quantify drug efficacy, the heterogeneous patient populations selected, and diagnostic noise.
This situation has led many mega-pharmaceutical companies to withdraw from drug discovery for psychiatric drugs, and global investment in psychiatric drug development has declined. Furthermore, there is often disagreement among neurobiologists about the mechanism by which a drug improves a condition. To address the current difficulties, it will be necessary to develop and apply:
- biological definitions of disease
- objective, non-invasive measurements for diagnosis
- neuroscientific support for drug development
- innovative therapeutic techniques based on non-drug neuroscience.
We at the ATR Brain Information Communication Research Laboratory Group, supported by the Japan Agency for Medical Research and Development and other organizations, have labored for 20 years to combine neuroscience research and artificial intelligence (AI) technologies to solve these problems. Finally, we have entered the stage of commercialization. XNef, Inc. was established to address these challenges by combining AI technology and brain science and by applying them to results obtained from national public medical care programs supported by MEXT and AMED. The name, XNef, is derived from a combination of DecNef (decoded neurofeedback) and FCNef (functional connectivity neurofeedback). XNef is pioneering a new generation of feedback therapy and corresponding data-driven biomarkers.
Specifically, our first goal is to analyze resting-state functional connectivity data from functional magnetic resonance imaging (fMRI) measurements of thousands of patients, using artificial intelligence technology to identify biological markers of brain disease networks so as to achieve disease diagnosis. Second, we use AI technology to analyze rs-FC to identify patient subtypes (*3) within individual diseases. This enables us to objectively identify groups of patients for whom a particular drug is effective and to develop a practical system to determine the most appropriate treatment for each patient. It further allows us to devise clinical development support technology that identifies and recruits appropriate patient subtypes, leading to successful clinical trials. Third, we will develop innovative therapies through decoded and functional connectivity neurofeedback.
To contribute to society, XNef is now constructing a diagnostic assistance network system that links MRI machines in many medical institutions with XNef's servers to provide diagnostic assistance services. Furthermore, XNef can provide clinical development support services to pharmaceutical companies that combine patient stratification and objective evaluation systems for drug efficacy. In the future, we will establish a system of clinically tested neurofeedback-based therapies at participating medical institutions to improve patient quality-of-life.
XNef, Inc. will develop patient-friendly medical technology that uses neuroscience and AI to overcome psychiatric disorders.
- (*1) DALY (disability-adjusted life year) is an overall measure of disease burden. It represents the number of years that a patient loses due to morbidity, disability, and premature death, combining mortality and morbidity into a single common measure.
- (*2) A "clinical trial" is a clinical test conducted to obtain approval under the Pharmaceutical and Medical Device Act for manufacture and sale of a drug or medical device. For drugs, clinical trials are often conducted in three phases. Phase I trials involve healthy adults who voluntarily participate in the study. Phase II evaluates the efficacy, safety, and pharmacokinetics of a drug in a small number of patients with relatively mild disease. Phase III is a larger scale study with the primary goal of verifying efficacy and safety in patients who will actually use the drug once it is commercially available.
- (*3) It is generally believed that a mental illness, even when called by one name, is not a single illness, but rather a collection of illnesses. These are called subtypes ("subcategories") of a single illness.