Monument Therapeutics and the Foundation for the National Institutes of Health (FNIH) will evaluate MT1988, in development for cognitive impairment associated with schizophrenia, in a proof-of-principle clinical trial. 

Many individuals begin to show signs of schizophrenia months or even years before receiving a diagnosis, referred to as the ‘clinical high risk’ (CHR) phase. 

The randomised, placebo-controlled study will enroll 150 CHR participants, who will receive one of two dose levels of MT1988 or placebo over an eight-week treatment period. 

The study will evaluate the potential of MT1988 to improve cognitive symptoms in CHR individuals. The approach is designed to assess not only therapeutic effects but also the potential of a range of clinical and cognitive biomarkers to predict and monitor treatment response.  

The trial is part of the FNIH-managed Accelerating Medicines Partnership Schizophrenia (AMP SCZ) programme, a public-private partnership between the National Institutes Health (NIH) and private sector organisations, including major pharmaceutical companies and nonprofit groups.  

The programme seeks to accelerate the development of more effective treatments for schizophrenia and related mental health conditions. It is supported by NIH grants awarded by the National Institute of Mental Health (NIMH) to Yale School of Medicine and Brigham and Women’s Hospital, representing a $44 million investment so far. 

Dr Kiri Granger, Chief Scientific Officer of Monument Therapeutics, commented: “This trial marks an exciting milestone for Monument to evaluate MT1988 in a patient population with our proprietary digital biomarker. Studying individuals at clinical high risk allows us to explore early cognitive changes and support the advancement of personalised treatment approaches in early-stage illness. We are thrilled to partner with FNIH and leading investigators on a study that represents a major step forward in developing meaningful treatment options for people at risk of schizophrenia.”

Diana Turner, Senior Digital Content Editor, DDW