EIP Pharma Announces Clinical Trial Results of REVERSE-SD, a Phase 2b Study of Neflamapimod in Early-stage Alzheimer’s Disease
Boston, Mass., November 7, 2019 – EIP Pharma, Inc. (www.eippharma.com), a CNS-focused therapeutics company, today announced that the REVERSE-SD study of neflamapimod in early-stage Alzheimer’s disease met its secondary objectives of target engagement and proof-of-mechanism demonstrating statistically significant reductions relative to placebo in cerebrospinal fluid (CSF) levels of phospho-tau and tau, the major markers of neurodegeneration and axonal damage. The study did not meet its primary objective of improving episodic memory at the end of the study period at week 24, as measured by Hopkins Verbal Learning Test (HVLT) and secondarily, the Wechsler Memory Scale (WMS) immediate and delayed recall. In pre-specified pharmacokinetic-pharmacodynamic (PK-PD) analyses, positive trends relative to placebo on both HVLT and WMS were evident in neflamapimod-treated patients whose plasma drug concentrations were in the highest quartile within the study. The efficacy and safety data from the study will be presented by the principal investigator of the study, Professor Philip Scheltens of the VU Medical Center in Amsterdam, Netherlands, at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting in San Diego on Thursday, December 5, 2019 at 11:45 AM.
“The CSF biomarker results are compelling, and support target engagement and proof-of-mechanism,” said Professor Philip Scheltens of the VU Medical Center in Amsterdam, and the principal investigator of the study. “Combined with the efficacy signal at higher plasma drug concentrations, the results of the Reverse-SD study indicate that neflamapimod continues to show promise as an Alzheimer’s therapeutic and that a study of neflamapimod at higher doses in patients with early Alzheimer’s disease is warranted.” （Article from : www.drugs.com)