Over the last decade, the prevalence of psychiatric disorders has increased by roughly 50% and today’s approved medicines only help about half of the patients who take them. The need for better treatment options for disorders such as depression, schizophrenia and ADHD is therefore substantial, yet approximately 95% of neuroscience drug candidates fail in clinical trials.
One major reason is that clinical diagnoses are imprecise targets for drug development. Diagnoses are intended to separate distinct conditions but in practice, symptoms overlap enormously. More than 70% of patients meet criteria for more than one psychiatric disorder, and patients with the same diagnosis can have very different biological causes for their symptoms. Trials have traditionally enrolled patients by diagnostic labels rather than underlying biology, so heterogeneity washes out true drug effects and results end up negative.
Precision psychiatry represents a new era for neuroscience drug development. It’s a departure from the traditional one-size-fits-all approach, and develops drugs to target the true biological basis of an illness alongside biomarkers to select the right patients. In oncology, biomarker-driven development is already standard and associated with a several-fold increase in the likelihood of drug approval.
Across psychiatry, a huge effort is being made to develop biomarkers to improve treatment response and drug development success rates, spanning modalities from digital cognitive measures and genetics to fMRI and EEG signals. Biomarker-driven drug development is not just desirable, it’s essential to improve clinical success.
Our upcoming proof-of-concept clinical trial with MT1988 (a nicotinic agonist) embraces this approach. We are deploying a range of biomarkers, including Monument’s proprietary biomarker, to predict pro-cognitive effects and monitor treatment response in people at clinical high risk (CHR) for psychosis.
Next week, we’ll dive into why CHR matters, how predictive biomarkers apply there, and what we’ve learned from past cognitive impairment in schizophrenia studies.
#FromSymptomstoSignals #PrecisionPsychiatry #Biomarkers #DrugDevelopment