US-based company EIP Pharma has reported positive results from a Phase 2a clinical trial evaluating neflamapimod (NCT02423122) in patients with early Alzheimer’s disease.
The three-month long trial enrolled 16 patients.
The major clinical finding of the trial was a statistically significant improvement in episodic memory function with neflamapimod, as evaluated by immediate recall and delayed recall composites of the relevant components of the Wechsler Memory Scale (WMS).
Over the treatment's duration, improvement was reported to be progressive and at the end the within-subject treatment Effect Size was in medium to large range, including 0.59 for immediate recall and 0.67 for delayed recall.
Furthermore, individual subject plasma drug concentration profiles were observed to be significantly and positively correlated with the change in combined WMS immediate and delayed recall.
The trial’s primary biomarker endpoint was change in brain amyloid plaque load by quantitative dynamic amyloid PET scanning, with four of the total enrolled patients meeting pre-defined responder criteria for a significant reduction in brain amyloid plaque load between baseline and month three PET scans.
The study did not find any correlation between improvement in episodic memory function and reduction in brain amyloid plaque load.
EIP Pharma CEO John Alam said: “Significant unmet need exists for improved Alzheimer’s treatments which is why we are so encouraged by these data demonstrating neflamapimod's potential to improve memory function in patients with Alzheimer's disease.”
The company aims to conduct a Phase 2b clinical study, REVERSE-SD, based on the results of the newly published Phase 2a trial. It is expected to take six months, and will include a total of 150 patients with mild Alzheimer’s disease.
In the study, patients will be randomised on a double-blind basis to receive placebo or 40mg of neflamapimod twice daily for 24 weeks.
The primary endpoint of the trial will be episodic memory, with secondary endpoints, including CDR-SB, MMSE, and CSF biomarkers.