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Monument Therapeutics partners with FNIH to advance MT1988, a promising treatment for cognitive impairment in schizophrenia, through a groundbreaking clinical trial.
The clinical trial for MT1988 marks the first of Monument’s precision medication pipeline to reach the patient trial phase.
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Monument Therapeutics announced its partnership with the Foundation for the National Institutes of Health (FNIH) to continue testing and advancing MT1988, a treatment option being developed for cognitive impairment associated with schizophrenia. The collaboration will focus on a proof of principle clinical trial for the treatment option and is the first patient trial in Monument’s drug treatment pipeline.
A severe mental health disorder ranking among the top 15 leading causes of disability worldwide, schizophrenia can be characterized by a variety of symptoms including auditory & visual hallucinations, delusions, and cognitive impairments affecting a patient’s attention, memory, reasoning, and processing speed. Signs of schizophrenia can appear months or even years ahead of diagnoses and is referred to as the CHR phase.
The Investigational New Drug (IND)-opening clinical trial for MT1988 is a randomized, placebo-controlled study employing 150 clinically high risk (CHR) patients who will receive one of two dosages of MT1988 or the placebo. The trial will be conducted over an eight-week period and is set to begin during autumn of 2025.
The clinical study aims to evaluate MT1988’s ability to improve cognitive symptoms in CHR patients, through the integration of a variety of clinical and cognitive biomarkers, including Monument’s proprietary digital biomarker. This method offers Monument the ability to assess MT1988’s therapeutic effects along with the biomarkers’ potential to predict and monitor treatment responses.
Mt1988’s trial study is part of FNIH-managed Accelerating Medicines Partnership Schizophrenia program, a public-private relationship held between NIH and private sector organizations which includes major pharmaceutical organizations along with non-profit groups. The program is designed to accelerate developments of effective schizophrenia and other related mental health issues. The program receives funding via FNIH grants awarded by the National Institute of Mental Health. Yale School of Medicine along with Brigham and Women’s Hospital are honorary recipients of the awards and represent and estimated $44 million investment into the program.
The clinical trial will see a variety of doctors co-leading the study which includes the following:
Dr. Kiri Granger, chief scientific officer of Monument Therapeutics, touched on the importance of the trial, saying, “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 personalized 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."1
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