UK-based Monument Therapeutics has partnered with the US Foundation for the National Institutes of Health (FNIH) to study MT1988, which is under development for treating cognitive impairment in schizophrenia patients.
Schizophrenia is known for its severe impact on mental health, with patients often experiencing a range of debilitating symptoms such as delusions, hallucinations and cognitive deficits that can hinder memory, attention and reasoning abilities.
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The upcoming proof-of-principle trial represents the first time a patient will be tested with a therapy from Monument’s pipeline of precision medicine.
The investigational new drug (IND)-opening, placebo-controlled, randomised trial is set to include 150 subjects deemed at clinical high risk (CHR) for schizophrenia.
These individuals will be administered either one of two dosage levels of the therapy or a placebo across a treatment period of eight weeks, with the trial expected to begin dosing this year.
The focus of the trial is to determine whether the therapy can alleviate cognitive symptoms in CHR subjects.
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By GlobalDataIt will incorporate a variety of cognitive and clinical biomarkers, including a digital biomarker of Monument, to evaluate the therapeutic effects and the biomarkers’ ability to predict and monitor the response to treatment.
Spearheading the MT1988 clinical trial are Yale School of Medicine’s Dr Scott Woods and Dr Youngsun Cho, as well as Brigham and Women’s Hospital’s Dr Martha Shenton and Dr Ofer Pasternak.
Also leading the trial are Dr Carrie Bearden from the University of California, Los Angeles, Northwell Health’s Dr John Kane, Université du Québec École de technologie supérieure’s Dr Sylvain Bouix, and Mount Sinai Icahn School of Medicine’s Dr Rene Kahn.
The trial is a component of the Accelerating Medicines Partnership Schizophrenia (AMP SCZ) programme, managed by FNIH.
Monument Therapeutics chief scientific officer Dr Kiri Granger said: “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.”
