Monument Therapeutics Announces First Patient Dosed in Trial of MT1988 in Patients at Clinical High Risk for Psychosis
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This randomized, placebo-controlled, proof-of-principle 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 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.
“We are excited to be leading this study with Monument Therapeutics, as this trial represents an important opportunity to evaluate biomarker changes in response to MT1988 across a diverse set of measures in individuals at clinical high risk for psychosis,” said Dr Scott Woods, Professor of Psychiatry at Yale School of Medicine and Principal Investigator of the study.
Schizophrenia is a severe mental health disorder and is among the top 15 leading causes of disability worldwide. The CHR syndrome for psychosis affects approximately 1.7% of young people and is associated with considerable cognitive and functional impairments that can emerge months or even years before full-blown psychosis and a schizophrenia diagnosis. In the same way that cutting-edge treatments are now targeting Alzheimer’s disease several years before dementia develops, this trial targets symptoms during the prodromal stages of schizophrenia, in the belief that treating people early will lead to better outcomes.
“Dosing our first patient marks a pivotal moment for Monument Therapeutics and for people at risk of developing psychosis, as despite the significant impact of this early stage of illness, there are currently no approved pharmacological treatments for the CHR population,” said Sheryl Caswell, Chief Development Officer of Monument Therapeutics.
“We are honored that MT1988 was competitively selected for this trial from many different drug candidates,” said Kiri Granger, PhD, Chief Scientific Officer of Monument Therapeutics. “This treatment has the potential to significantly improve the lives of patients at risk of developing psychosis, which would be a tremendous breakthrough given the high unmet clinical need.”
By evaluating biomarkers and targeted therapeutics in early intervention for individuals at CHR for psychosis, this trial will guide future clinical development and support the continued advancement of MT1988 in schizophrenia.
About Monument Therapeutics:
Monument Therapeutics is a neuroscience-focused drug development company headquartered in Manchester, UK. It applies a unique and novel drug development strategy, leveraging digital assessments of cognition to select patients suitable for treatment with the innovative drugs that it is developing. For more information, please visit www.monumenttx.com.
About the Foundation for the National Institutes of Health:
The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient organizations, foundations, and regulatory agencies (including the U.S. Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health; and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.
About the Accelerating Medicines Partnership®:
Launched in 2014 and managed by the FNIH, the Accelerating Medicines Partnership (AMP) program brings together the National Institutes of Health, U.S. Food and Drug Administration, biomedical and life sciences companies, nonprofits, patient-focused groups, and other organizations to transform the current model for developing new diagnostics and treatments. Using cutting-edge scientific approaches and broad sharing of research data, all AMPs seek to improve understanding of disease pathways, facilitate better selection of targets for drug development, and streamline processes for bringing new treatments to patients. To learn more about AMP, visit fnih.org/AMP.
For further information, contact:
Jenny Barnett, CEO
E: jbarnett@monumenttx.com
Jenny Barnett, CEO
Monument Therapeutics
jbarnett@monumenttx.com
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