Clinical-stage biopharmaceutical company MapLight Therapeutics on Monday announced results from its Phase 1 trial assessing the safety, tolerability and pharmacokinetics of ML-007/PAC in healthy adult and elderly volunteers.

ML-007 has now been evaluated both a single agent and in combination with a peripherally acting anticholinergic (PAC), across four Phase 1 trials with 270 subjects enrolled.

ML-007/PAC was generally well tolerated at the doses proposed for the Phase 2 clinical trials. Most treatment-emergent adverse events were mild and transient in nature, and no severe or serious adverse events were observed. Plasma and CSF exposures were maintained above anticipated clinically relevant levels with both once- and twice-daily dosing regimens. Pharmacokinetic parameters were similar between adult and elderly volunteers and confirmed that the dosing in the planned Phase 2 trials will not require administration in a fasted state.

MapLight is planning to commence Phase 2 trials of ML-007/PAC in schizophrenia and Alzheimer's disease psychosis (ADP) in the first half of 2025.

Erin Foff, MD., PhD, MapLight's chief medical officer, said: "We are encouraged by the favourable safety and tolerability profile demonstrated across our Phase 1 trials and feel confident in progressing to the next phase of clinical development. The results of this study provided critical data informing the final dosing and administration protocols for our planned Phase 2 trials in schizophrenia and ADP. We are excited to move one step closer to potentially giving patients and their caregivers a better treatment option."