Monument Therapeutics Launches First Clinical Study of MT1988, a Novel Treatment for Cognitive Impairment Associated with Schizophrenia

Monument Therapeutics, a precision neuroscience company, today announced the first participant has been successfully dosed in its Phase I clinical study of MT1988, a novel treatment targeting cognitive impairment associated with schizophrenia (CIAS). MT1988 is a fixed-dose combination of two well-established small molecules that act on nicotinic receptors, designed to optimise safety and efficacy.

Schizophrenia is a severe mental health disorder and ranks among the top 15 leading causes of disability worldwide. CIAS is a core symptom of schizophrenia that affects memory, attention, and executive function. Despite its significant impact on patients' daily lives, there are currently no approved treatments for CIAS, leaving a major unmet need within the therapeutic landscape for schizophrenia.

Preclinical studies of MT1988 have demonstrated promising results, highlighting its potential to improve cognitive deficits associated with schizophrenia. This Phase I placebo-controlled trial is designed to evaluate the safety, tolerability and pharmacokinetics of MT1988 in healthy adults over a 14-day dosing period, with initial results expected in Q1 2025.

MT1988 is designed to be used alongside existing anti-psychotic medications for schizophrenia, to finally address the cognitive symptoms that have long remained untreated.  

Sheryl Caswell, Chief Development Officer of Monument Therapeutics, said: "The initiation of our Phase I study for MT1988 marks a significant milestone in its clinical development. Our team has worked diligently to advance this innovative treatment from preclinical research to human trials, and we are excited to evaluate its potential to improve cognitive outcomes for patients with schizophrenia. Addressing cognitive impairment is vital to enhancing quality of life for those affected, and we are proud to lead this effort."

Dr Lyn Corry, Principal Investigator for the study at BDD Pharma, said: "We are delighted to be working with the Monument Therapeutics team to help advance the clinical development of this product which has the potential to make a significant impact on the lives of patients with cognitive impairment associated with schizophrenia."