CAMBRIDGE, Mass., Dec 13, 2018 /PRNewswire/ -- EIP Pharma, Inc. (www.eippharma.com), a CNS-focused therapeutics company, announced today that it has fully enrolled the REVERSE-SD study, a placebo controlled, Phase 2b trial of the investigational drug neflamapimod in patients with Early Alzheimer's disease. The Phase 2b trial is being conducted in the United States, United Kingdom, Netherlands, Denmark and the Czech Republic. Neflamapimod is a brain-penetrant oral small molecule that inhibits the enzyme p38 alpha, an intracellular kinase implicated in the development of synaptic dysfunction (SD) in Alzheimer's disease.
"We are pleased to have completed patient enrollment in the 6-month Phase 2b (REVERSE-SD) clinical study which is designed to evaluate neflamapimod's activity in reversing synaptic dysfunction, as assessed by tests of episodic memory in patients with Early Alzheimer's disease," said John Alam, Chief Executive Officer of EIP Pharma. "We look forward to reporting topline data from the trial in the fall of 2019."
The REVERSE-SD study will evaluate 152 patients with Early Alzheimer's disease, randomized on a double-blind basis to placebo or 40 mg of neflamapimod twice daily for 24 weeks. Inclusion criteria include Clinical Dementia Rating scale (CDR) 0.5 or 1.0 with documented memory deficit, MMSE 20 to 28, and positive AD-related cerebrospinal fluid biomarkers. The primary endpoint is episodic memory, as assessed with the Hopkins Verbal Learning Test, with secondary endpoints including CDR-SB, MMSE, and CSF biomarkers. Further details are available at https://clinicaltrials.gov/ct2/show/NCT03402659.
About neflamapimod (VX-745) and p38 MAPKα
Neflamapimod (formerly VX-745) is a brain-penetrant oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38α). p38α, which is expressed in neurons under conditions of stress and disease, plays a major role in inflammation and/or amyloid beta induced synaptic toxicity, including the impairment of synaptic function (specifically synaptic plasticity). Synaptic plasticity is known to be a major driver of the development of deficits in learning and memory formation that are defining characteristics of Alzheimer's disease. Phase 2a clinical trial data were published in April 2018 in the Annals of Clinical and Translational Neurology and are available on an open access basis through the following: (https://doi.org/10.1002/acn3.549).
Neflamapimod was discovered by Vertex Pharmaceuticals, Inc. and licensed by EIP Pharma in 2014.
About EIP Pharma
EIP Pharma, Inc. (www.eippharma.com) is a private, Cambridge, MA-based company advancing CNS-focused therapeutics for improved patient benefit. For more information please visit www.eippharma.com.
SOURCE EIP Pharma, Inc.