July 18, 2017
EIP Pharma announces presentation of new positive clinical data with neflamapimod (VX-745) at Alzheimer’s Association International Conference (AAIC)
CAMBRIDGE, Mass., July 18, 2017 /PRNewswire/ — EIP Pharma, LLC (www.eippharma.com) today announced that new clinical data with neflamapimod were presented at the AAIC 2017 scientific meeting in London, UK (July 16-20, 2017; https://www.alz.org/aaic/). The clinical data were reported in an oral presentation:
Title: Evidence That Oral p38 MAPK Alpha Antagonism Improves Episodic Memory in Patients with Early Alzheimer’s Disease (AD).
Authors: Prins ND, Alam J, Chu HM, and Scheltens P.
Presentation given by Niels Prins, MD PhD, Department of Neurology and Alzheimer Center, VU University Medical Center; and the Brain Research Center; Amsterdam, Netherlands.
The authors reported on further analyses of the episodic memory findings from two phase 2a clinical studies of neflamapimod in patients with early-stage Alzheimer’s disease (Study 302 and Study 303). As reported originally at CTAD meeting in Dec 2016, the two clinical trials met their primary objectives by demonstrating disease-relevant pharmacologic activity; and secondarily demonstrated statistically significant improvement in measures of episodic memory. The new analyses revealed consistent and substantial treatment effects on immediate and delayed recall aspects of episodic memory, as within-subject effect sizes (Cohen’s davg) were similar between the two studies and ranged between 0.59 and 0.86. In addition, Pharmacokinetics-Pharmacodynamics analyses revealed indicated individual subject plasma drug concentration profiles were significantly correlated to change in combined Wechsler Memory Scale-Immediate and Delayed-Recall (r2=.70, p=0.001).
The authors concluded, “Consistency across the studies using different measures, robustness of statistics, effect size and drug concentration-response relationship preliminarily indicates a positive effect of neflamapimod on episodic memory. A 6-month placebo-controlled study is planned to confirm these findings.”
The treatment duration was twelve weeks in Study 302 and six weeks in Study 303. Episodic memory was assessed by immediate and delayed recall composites of the Wechsler Memory Scale in Study 302 and the Hopkins Verbal Learning Test in Study 303. More information on the design of the studies is provided at clinicaltrials.gov (NCT02423122 and NCT02423200, respectively).
About neflamapimod (VX-745) and p38 MAPKα
Neflamapimod is the international nonproprietary name (INN) for the investigational drug discovered by Vertex Pharmaceuticals that had previously been code designated VX-745. EIP Pharma licensed neflamapimod from Vertex in 2014. Neflamapimod is a brain-penetrant oral small molecule that inhibits the intra-cellular enzyme p38 mitogen activated protein kinase alpha (p38α).
In the healthy brain, p38a regulates inflammation through effects on immune cells. In conditions of stress and disease, p38α is also expressed in neurons; where it plays a major role in inflammation and/or amyloid beta induced synaptic toxicity, including the impairment of synaptic plasticity that is a major driver of the development of deficits in learning and memory formation which are defining characteristics of Alzheimer’s disease.
About EIP Pharma LLC
EIP Pharma LLC (www.eippharma.com) is a private R&D stage CNS-focused therapeutics company based in Cambridge, Massachusetts.
SOURCE EIP Pharma, LLC