On 7 November, EIP Pharma Inc., a company developing therapeutic drugs to benefit patients with neurodegenerative diseases including Alzheimer’s disease (AD), dementia with Lewy Bodies (DLB) and Huntington’s disease, announced results from the Phase II REVERSE-SD study that examined neflamapimod in early AD. Neflamapimod is an oral brain-penetrant molecule that inhibits the protein kinase p38 alpha, a kinase suggested to lead to the dysfunction of synapses that causes cognitive function deficits related to several neurodegenerative diseases. REVERSE-SD was designed as a randomised, double-blind and placebo-controlled study, enrolling 161 participants with early AD from 38 centers across US and Europe. Over a period of 24 weeks, participants received capsules of neflamapimod (40 mg) or a placebo control twice daily with food.
The company reported that the study failed to meet its primary objective of demonstrating improvement in episodic memory and delayed recall at week 24. The improvement was determined using the Hopkins Verbal Learning Test (HVLT) and the Wechsler Memory Scale (WMS). However, the study met its secondary objectives of target engagement and proof-of-mechanism demonstrating a statistically significant decrease in phospho-tau and tau protein levels, two known markers of neurodegeneration, in the cerebrospinal fluid compared to the placebo. Neflamapimod was found to be well tolerated with two discontinuations due to adverse events of nausea and myeloma. Data will be presented at the upcoming CTAD conference (San Diego, 4-7 December 2019).
Separately, EIP Pharma announced that neflamapimod has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of DLB. The company is currently recruiting participants for the Phase II AscenD-LB study. This double-blind and placebo-controlled trial evaluating neflamapimod in mild-to-moderate DLB is aiming to recruit 80 participants across 20 sites in the US and Netherlands. Data are expected in the second half of 2020.
