ProMIS Neurosciences has announced positive top-line findings from the Phase Ia clinical trial of PMN310, a humanised monoclonal antibody, in healthy volunteers for potential Alzheimer’s disease treatment.
The randomised, double-blind, placebo-controlled trial assessed intravenously administered PMN310’s safety and tolerability in healthy subjects.
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With SAD [single-ascending dose] cohorts, the study was conducted across two active sites in the US enrolling a total of 40 subjects.
The company reported results from the first four cohorts while the fifth and final cohort are currently under final assessment.
The trial has shown that PMN310 is well-tolerated and has a favourable safety profile.
Data from the first four cohorts also demonstrated that PMN310 crossed the blood-brain barrier in a dose-dependent manner, reaching concentrations that indicate sufficient target engagement for the planned follow-on trial in Alzheimer’s patients.
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By GlobalDataThe trial’s initiation was based on nonclinical studies that highlighted PMN310’s selective targeting of AβOs, a potential cause of Alzheimer’s.
No treatment-emergent serious adverse events were observed in the trial.
PMN310 levels in the cerebrospinal fluid showed dose proportionality and exceeded the expected levels of oligomers by over a hundredfold.
The half-life of PMN310 in the CSF was approximately 25 days, suggesting that monthly dosing could be feasible.
ProMIS Neurosciences chief medical officer Larry Altstiel said: “These encouraging data from the first four cohorts of our first-in-human Phase Ia clinical trial of PMN310 in healthy volunteers support the safety and tolerability profile of PMN310, and the levels of PMN310 in the CSF suggest its potential for target engagement.
“Importantly, these results will inform the dosing of our Phase Ib clinical trial in Alzheimer’s patients, which is on track to initiate in the second half of 2024.”
