Schizophrenia is a severe mental health disorder that is characterised by a range of symptoms such as hallucinations, delusions and cognitive impairments that affect attention and reasoning. It is common for individuals to show signs of schizophrenia months or years before receiving a diagnosis. This period is referred to as a clinical high risk (CHR) phase and is currently without treatment options.
The Investigational New Drug (IND) opening clinical trial for MT1988 is the first patient trial from Monument's precision medicine pipeline. The study will enrol 150 CHR participants who will receive one or two dose levels of MT1988 or placebo over an eight-week treatment period. The trial is scheduled to take place in late 2025.
The study will evaluate the potential of MT1988 to improve cognitive symptoms in CHR individuals. The project will integrate a range of clinical and cognitive biomarkers, including Monument’s proprietary digital biomarker. The approach is designed to assess therapeutic effects alongside the potential of biomarkers to predict and monitor treatment response.
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.”
She continued: “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."