The Neuracept trial was a double blind, placebo-controlled study of NP-1 in 215 diabetic peripheral neuropathy (DPN) patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between NP-1 and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715) in this Phase II study. Key secondary endpoints measured in the trial from a responder analysis indicate that 60% of patients in the NP-1 treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078).
EpiCept NP-1 is currently being studied in two additional clinical trials: a Phase III trial in chemotherapy-induced peripheral neuropathy (CPN) which is being conducted by the National Cancer Institute (NCI)-funded Community Clinical Oncology Program; and a Phase IIb comparative trial versus gabapentin and placebo in post-herpetic neuralgia (PHN). EpiCept anticipates completing enrollment for the PHN trial in the second quarter of 2008.
Stephane Allard, chief medical officer of EpiCept, said: “With this data and the data from our earlier Phase II trials, we are able to move forward with the design of a pivotal Phase III clinical trial program intended to lead to an NDA filing for NP-1 in the treatment of neuropathic pain.”