BioVie has achieved its revised enrolment target of 400 subjects in the NM101 Phase III trial of NE3107 for the treatment of Alzheimer’s disease.
The potentially pivotal, randomised, placebo controlled, double blind, parallel group, multi-centre trial has been designed for assessing NE3107 in patients with mild to moderate Alzheimer’s disease.
The trail’s co-primary endpoints are cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).
Top line results from the study are expected in October this year.
Originally, the Phase III trial protocol specified enrolment of a minimum of 316 patients equally randomised into treatment and placebo arms.
The protocol also pre-specified the potential for the data safety monitoring board (DSMB) review, in such a way that is blinded to BioVie, when approximately half of the 316 enrolled patients conclude the trial to determine if an increase in enrolment might be desirable to improve the probability of achieving statistical significance.
The company noted that 316 patients were enrolled before 50% of them had completed the study, due to an increasing pace of enrollment as the trial progressed.
BioVie president and CEO Cuong Do said: “We look forward to having topline data from this trial in October.
“We are optimistic that this trial will provide similar data to what was seen in the Phase II exploratory study, which showed that patients treated with NE3107 experienced enhanced cognition as measured by multiple assessment tools, including a 2.1 points improvement on the modified ADAS-Cog12 scale.”
The oral small molecule, blood-brain permeable compound NE3107 has potential anti-inflammatory, insulin sensitising, and ERK-binding properties.
With these properties, it is expected to selectively inhibit ERK-, NFκB-, and TNF-stimulated inflammation.