News

October 24, 2018

EIP Pharma Announces Clinical Study Presentations at the 11th Clinical Trials on Alzheimer’s Disease Conference and Provides Update on Phase 2b Clinical Study Enrollment

CAMBRIDGE, Mass., Oct. 24, 2018 /PRNewswire/ — EIP Pharma, Inc. (www.eippharma.com), a CNS-focused therapeutics company, announced today that two abstracts on the use of neflamapimod as a treatment for Early Alzheimer’s disease will be presented at the 11^th Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in Barcelona from October 24 to 27.  EIP Pharma also announced that the Phase 2b clinical study (REVERSE-SD) of neflamapimod has reached an important milestone of being more than 50 percent enrolled. The Phase 2b study is being conducted under an IND in the United States, and with Clinical Trial Application approvals for the study in the 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.

“The 6-month Phase 2b (REVERSE-SD) clinical study 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 Pharmaceuticals. “We are pleased with the progress with the study to date and look forward to obtaining the clinical data from this trial in the second half of 2019.”

Data Presentations at CTAD 
The following abstracts will be presented at the CTAD conference:

• Poster Presentation (P90) – REVERSE-SD: ongoing phase-2b study of neflamapimod designed in accordance with emerging scientific and regulatory concepts of early Alzheimer’s disease (AD) 
  Authors: John Alam, MD; Kelly Blackburn; Niels Prins, MD, PhD; Philip Scheltens, MD, PhD
  
  
• Late-Breaking Poster (P32) – BDNF as a biomarker for the effects of p38 MAPKα inhibition on IL-1β-induced impairment of hippocampal synaptic plasticity 
  Authors: John Alam, MD; Charlotte Teunissen, PhD; Niels Prins, MD, PhD; Hui-May Chu, PhD; Philip Scheltens, MD, PhD

About REVERSE-SD 
The REVERSE-SD study will enroll 152 patients with Early Alzheimer’s disease who will be 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, Incorporated 
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.