Monument Therapeutics, a stratified medicine company, today announced a partnership with the Foundation for the National Institutes of Health (FNIH) to evaluate MT1988, a novel treatment in development for cognitive impairment associated with schizophrenia, in a proof of principle clinical trial.
Schizophrenia is a severe mental health disorder and ranks among the top 15 leading causes of disability worldwide. It is characterized by a range of symptoms, including auditory and visual hallucinations, delusions, and cognitive impairments that affect attention, memory, reasoning, and processing speed. Many individuals begin to show signs of schizophrenia months or even years before receiving a diagnosis. This period, referred to as the ‘clinical high risk’ (CHR) phase, is currently without effective treatment options, despite its profound impact on functioning and quality of life.
This Investigational New Drug (IND)-opening clinical trial for MT1988 is the first patient trial from Monument’s precision medicine pipeline. The randomized, 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 trial is on track to begin dosing in the autumn of 2025.
The study will evaluate the potential of MT1988 to improve cognitive symptoms in CHR individuals, incorporating a range of clinical and cognitive biomarkers including Monument’s proprietary digital biomarker. This approach is designed to assess not only therapeutic effects but also the potential of these biomarkers to predict and monitor treatment response.
The trial is part of the FNIH-managed Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) program, a public-private partnership between the National Institutes Health (NIH) and private sector organizations, including major pharmaceutical companies and nonprofit groups. The program 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 (U01MH137298) and Brigham and Women’s Hospital (U24MH137171), representing a $44 million investment so far.
The clinical trial with MT1988 will be co-led by Dr. Scott Woods and Dr. Youngsun Cho from Yale School of Medicine, Dr. Carrie Bearden from University of California, Los Angeles (UCLA), Dr. John Kane from Northwell Health, Dr. Martha Shenton and Dr. Ofer Pasternak from Brigham and Women’s Hospital, Dr. Sylvain Bouix from École de technologie supérieure, Université du Québec, and Dr. Rene Kahn from Icahn School of Medicine at Mount Sinai. This distinguished team brings together diverse expertise across psychiatry, neuroscience, and data science, highlighting a unified commitment to advancing early intervention for schizophrenia.
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.”
