MapLight Therapeutics, a clinical-stage biopharmaceutical company working to develop targeted novel therapeutics to improve the lives of patients suffering from debilitating CNS disorders, announced initiation of a Phase 1 clinical trial evaluating ML-007/PAC, MapLight’s extended-release fixed-dose combination formulation of the novel, investigational muscarinic agonist ML-007 and a precision-matched peripherally active anticholinergic (PAC). This trial builds upon findings from three prior Phase 1 clinical trials evaluating safety and tolerability of ML-007 co-administered with the PAC.
This four-cohort trial will evaluate the safety, tolerability and pharmacokinetics (PK) of several dose strengths of ML-007/PAC in healthy non-elderly and elderly adults.
“We are pleased with the continued progress of our ML-007 clinical development program,” stated Christopher Kroeger, M.D., MBA, Chief Executive Officer and Founder. “We have already evaluated the safety and tolerability profile of ML-007 dosed alone or with the PAC in three clinical trials and observed favorable tolerability results in adults, including in elderly subjects. Data from this fourth Phase 1 trial will inform the ML-007/PAC dosing regimen to bring forward into our planned Phase 2 trials in schizophrenia and Alzheimer’s disease psychosis. We look forward to initiating our first Phase 2 trial of ML-007/PAC in schizophrenia later this year.”
“There still remains a profound level of unmet need in the treatment of schizophrenia with about 60% of patients having only a partial response or no response to treatment,” said John Kane M.D., Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “The clinical trial evidence for muscarinic receptor agents has been very encouraging, and I believe this new class of agents has the potential to improve the overall treatment of schizophrenia.”
SOURCE: PRNewswire
