Treatment & Results

 

Neflamapimod targets and inhibits p38 alpha, a cellular enzyme linked to the inflammation and synaptic dysfunction that cause neurological disease progression. EIP Pharma is developing neflamapimod for the treatment of central nervous system (CNS) disorders.

Current Trials

REVERSE-SD Phase 2b

Fully Enrolled

EIP Pharma is currently conducting a randomized, phase 2b clinical trial to confirm the effects of neflamapimod on reversing synaptic dysfunction and improving episodic memory in patients with mild Alzheimer’s disease. This trial will also give us important insights into treating synaptic dysfunction in other CNS diseases.

REVERSE-SD is a double-blind, 6-month clinical trial designed to evaluate neflamapimod’s activity in reversing synaptic dysfunction, assessed by evaluating episodic memory in patients with early-stage Alzheimer’s disease. 161 patients have been enrolled and randomized to either placebo or 40 mg of neflamapimod twice daily for 24 weeks. The results from this study will be available in the fall of 2019.

Learn more about this trial at Clinicaltrial.gov

Dementia with Lewy Bodies Trial, Phase 2

Currently Recruiting

EIP Pharma is currently conducting a randomized double-blind, placebo-controlled clinical trial to investigate the effects of neflamapimod on reversing synaptic dysfunction and improving cognition in patients with mild-to-moderate dementia with Lewy Bodies (DLB). The trial, a study of cognitive effects of neflamapimod in dementia with Lewy Bodies (AscenD-LB ), is being conducted in the United States and Netherlands. To be eligible patients must be at least 55 years old, have probable DLB with identified cognitive impairment according to consensus criteria and a Mini-Mental State Exam (MMSE) score 15-28 inclusive. Patients also need to have been on cholinesterase inhibitor therapy > 3 months. Data from the study are expected to be available in the second half of 2020.

Learn more about this trial at Clinicaltrials.gov

Huntington’s Disease Trial, Phase 2a

Currently Recruiting

EIP Pharma is currently conducting a double-blind, placebo-controlled, crossover clinical trial to investigate the effects of neflamapimod on reversing synaptic dysfunction and improving cognitive function in patients with early-stage Huntington’s disease. The study is being conducted at one site in Cambridge, UK and will evaluate 16 patients in the cross-over design. Patients are eligible if they are aged 30 to 70 years old and have Stage 1 Huntington’s disease with identified cognitive deficits.

Learn more about this trial at Clinicaltrials.gov

Phase 2a Clinical Results

To date, neflamapimod’s activity in CNS disease has been evaluated in two phase 2a clinical studies, both focusing on early-stage Alzheimer’s disease.

  • Study 302, a 12-week treatment study conducted at VU Medical Center in Amsterdam, Netherlands.
  • Study 303, a 6-week treatment study conducted at the Early Clinical Phase Unit – Los Angeles, part of Parexel International.

Results from both studies demonstrated that neflamapimod is well tolerated, crosses the blood brain barrier and is pharmacologically active in the brain. We also obtained preliminary evidence that the drug improves the outcome of patients, as tested by episodic memory assessment.

Preclinical Results

EIP Pharma has conducted preclinical studies of neflamapimod in several mouse and rat models of neurological disease, including an aged rat model, an induced ischemia rat model, and a transgenic amyloid plaque-producing mouse model. In these models, neflamapimod improved neurological outcomes, supporting its use to treat neurological disorders in human patients. Learn more.

Clinical Milestone Pipeline

See the milestones reached and the clinical trial timetable for each of EIP Pharma’s areas of focus.

Pipeline

"Neflamapimod treatment showed improvement in memory tests that assess immediate and delayed recall in two phase 2a studies, strongly suggestive of reversal of synaptic dysfunction. With the demonstration of proof-of-mechanism and the definition of an optimal dose, neflamapimod is well positioned to demonstrate proof-of-concept on clinical cognitive endpoints in a subsequent study in patients with early Alzheimer's disease."

Professor Philip Scheltens, principal investigator for Study 302 and Director of the Alzheimer's Centre at the VU Medical Center