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The Phase I trial was designed to evaluate the safety, tolerability and pharmacokinetics of MT1988 in healthy adult participants over 14 days of daily oral dosing. The drug was generally well-tolerated with no severe or serious adverse events reported.
These results support the advancement of MT1988 into Phase II clinical development, targeting cognitive impairment associated with schizophrenia and related conditions.
“The successful completion of this Phase I trial is a key milestone in the development of MT1988, demonstrating a favourable safety and tolerability profile,” said Sheryl Caswell, Chief Development Officer of Monument Therapeutics. “We are excited to advance MT1988 into Phase II trials, where we aim to demonstrate clinical proof of concept in improving cognitive function in patients living with schizophrenia and related conditions – a high-need area with no approved treatments.”
Dr Lyn Corry, Principal Investigator for the study at BDD Pharma, commented “I’m encouraged by the safety and tolerability profile observed in this Phase I trial. MT1988 was generally well-tolerated with only mild to moderate adverse events reported. These findings support further clinical development of MT1988 in patients with schizophrenia, where it has the potential to become a highly valuable therapy.”
Addressing an unmet need in schizophrenia treatment:
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.
MT1988 is designed to be used alongside existing anti-psychotic medications for schizophrenia, to address the cognitive symptoms that have long remained untreated.
“Its’s encouraging to see novel treatments like MT1988 progressing through clinical development for CIAS,” said Dr Stephen Brannan, member of Monument’s Scientific Advisory Board. For people living with schizophrenia, cognitive symptoms can be profoundly debilitating, and continued research in this area represents an important part of the ongoing effort toward better treatment options for this condition”.
About Monument Therapeutics:
Monument Therapeutics applies a unique novel drug development strategy, leveraging digital assessments of cognition to match patients with new pharmaceutical treatments. Lead asset MT1988 targets the cognitive symptoms of schizophrenia, which are extremely costly for society and profoundly impact the affected individuals and their quality of life.
For more information, please visit www.monumenttx.com
About BDD Pharma:
BDD is an integrated UK-based clinical research organisation whose Lean Clinical Development pathway combines formulation development, GMP manufacturing and phase I clinical studies to accelerate product development.
For more information, please visit www.bddpharma.com
For further information, contact:
Jenny Barnett, CEO
E-Mail: [email protected]
Dr Jenny Barnett
Monument Therapeutics
email us here
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