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.

Clinical Trials

Dementia with Lewy Bodies Trial, Phase 2

Study Completed

EIP Pharma conducted 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, was conducted in the United States and Netherlands. Patients in this study had a diagnosis of DLB that corresponded to mild to moderate disease and received a stable dose of cholinesterase inhibitor therapy (>3 months). Results of the study were positive and neflamapimod showed a significant and positive effect on cognition and functional mobility in patients with mild to moderate DLB. Initial results were presented at the 13th Clinical Trials in Alzheimer’s Disease (CTAD) meeting in November 2020 and final results will be presented at the 14th CTAD meeting in November 2021.

REVERSE-SD Phase 2b

Study Completed

REVERSE-SD was 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 were enrolled and randomized to either placebo or 40 mg of neflamapimod twice daily for 24 weeks. The results from this study have been published. Results of the study showed target engagement of neflamapimod by demonstrating that neflamapimod reduced tau and ptau in CSF of AD patients. In this 6-month study, no discernable effect on cognition was seen on the overall population but a positive trend on cognition was observed in patients with the highest drug concentration level suggesting that a higher dose should be explored in subsequent longer duration trials to evaluate neflamapimod as a treatment to slow disease progression in AD.

Huntington’s Disease Trial, Phase 2a

Study discontinued due to COVID19 restrictions

EIP Pharma conducted 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 was being conducted at one site in Cambridge, UK and was to evaluate 16 patients in the cross-over design. This study was discontinued because COVID19 restrictions impeded the completion of the trial, which because of its within-subject crossover design required patient participation in the study for at least nine months.

Phase 2 Clinical Results

Dementia with Lewy Bodies

Phase 2

EIP Pharma conducted a randomized double-blind, placebo-controlled clinical trial to investigate the effects of neflamapimod on reversing synaptic dysfunction and improving cognition and functional mobility in patients with mild-to-moderate dementia with Lewy Bodies (AscenD-LB). The trial was conducted in the United States and Netherlands. Patients in this study had a diagnosis of DLB that corresponded to mild to moderate disease and received a stable dose of cholinesterase inhibitor therapy (>3 months). 91 patients were enrolled and randomized to placebo or neflamapimod 40mg twice or thrice daily. Results of the study were positive and neflamapimod showed a significant and positive effect on cognition and functional mobility in patients with mild to moderate DLB. Learn more.

Alzheimer’s Disease

Neflamapimod’s activity in CNS disease has been evaluated in two phase 2a clinical studies, both focusing on early-stage Alzheimer’s disease and in a placebo-controlled phase 2b study in patients with early-stage Alzheimer’s disease.

Phase 2a
  • 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.

Phase 2b

Neflamapimod has also been studied in a placebo controlled study of 24 weeks in patients with early-stage Alzheimer’s disease (REVERSE-SD). REVERSE-SD was 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 were enrolled and randomized to either placebo or 40 mg of neflamapimod twice daily for 24 weeks. The results from this study were reported at the Clinical Trials in Alzheimer’s Disease meeting in December 2019. Results of the study showed target engagement of neflamapimod by demonstrating that neflamapimod reduced tau and ptau in CSF of AD patients. In this 6 month study, no discernable effect on cognition was seen on the overall population but a positive trend on cognition was observed in patients with the highest drug concentration level suggesting that a higher dose should be explored in subsequent trials. Learn more.

Preclinical Results

Neflamapimod has also been studied in a placebo-controlled study of 24 weeks in patients with early-stage Alzheimer’s disease (REVERSE-SD). REVERSE-SD was 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 were enrolled and randomized to either placebo or 40 mg of neflamapimod twice daily for 24 weeks. The results from this study have been published. Results of the study showed target engagement of neflamapimod by demonstrating that neflamapimod reduced tau and ptau in CSF of AD patients. In this 6-month study, no discernable effect on cognition was seen on the overall population but a positive trend on cognition was observed in patients with the highest drug concentration level suggesting that a higher dose should be explored in subsequent trials. Learn more.

Clinical Milestone Pipeline

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

Pipeline

"The demonstrated positive effects on the AscenD-LB study’s primary endpoint, cognition, and as well as on a number of secondary endpoints, establishes proof-of-concept for neflamapimod as a possible treatment for patients with dementia with Lewy bodies. If these findings are confirmed in phase 3 clinical studies, neflamapimod could potentially become the first approved therapy for this devastating disease. DLB is not only the second most common neurodegenerative dementia but is also associated with substantial reduction of patient quality of life and high caregiver burden.”

Stephen Gomperts, MD, PhD, Director, Lewy Body Dementia Unit and Assistant Professor of Neurology at Massachusetts General Hospital