BDD’s Phase 1 Trial Reports Positive Phase I Results for Novel Cognitive Impairment Associated with Schizophrenia Treatment
BDD is delighted to have supported Monument Therapeutics in conducting their Phase I clinical trial for MT1988, an innovative treatment targeting cognitive impairment associated with schizophrenia (CIAS).
This trial, conducted at BDD’s clinical facility, evaluated the safety, tolerability, and pharmacokinetics of MT1988 in healthy adult participants. The successful outcome, demonstrating a favourable safety profile and good tolerability, supports advancing MT1988 into Phase II clinical trials.
BDD’s Principal Investigator, Lyn Corry, noted the encouraging results and highlighted the potential of MT1988 to significantly benefit patients living with schizophrenia – a condition with substantial unmet treatment needs. BDD is proud to have contributed to this important milestone and looks forward to further supporting Monument Therapeutics in the ongoing development of therapies addressing critical mental health challenges.
PRESS RELEASE FOLLOWS:
Monument Therapeutics Reports Positive Phase I Results for
Novel Cognitive Impairment Associated with Schizophrenia
Treatment
Manchester, UK, 23 June 2025 – Monument Therapeutics, a precision
neuroscience company, today announced positive topline results from its Phase I
clinical trial evaluating 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.
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: jbarnett@monumenttx.com