EIP Pharma announced positive results from the Phase 2 AscenD-LB study in patients with mild-to-moderate dementia with Lewy bodies (DLB). Data showed that the trial met its primary endpoint of demonstrating an improvement in cognition as assessed by the Neuropsychological Test Battery (NTB). The full results have been accepted as a late-breaking abstract and will be shared on November 7, 2020 during an oral presentation at the 13th Clinical Trials in Alzheimer’s Disease (CTAD) meeting.
AscenD-LB was a double-blind, placebo-controlled, 16-week treatment study in patients with mild-to-moderate dementia with Lewy bodies (DLB), conducted at 22 centers in the United States and two centers in the Netherlands. 91 patients were enrolled between October 2019 and March 2020 and randomized to receive 40 mg neflamapimod capsules or matching placebo capsules (randomized 1:1) for 16 weeks. The dosing regimen was based on weight, with study participants weighing less than 80 kg receiving capsules twice-daily (BID) and those weighing greater than or equal to 80 kg received capsules three-times-a-day (TID). The primary objective was to evaluate the effect of neflamapimod on cognition as assessed in a study-specific Neuropsychological Test Battery (NTB) that was designed to primarily evaluate attention and executive function.
Patients receiving neflamapimod three times daily (TID) demonstrated significant improvement on the NTB compared to those who received either placebo or neflamapimod BID. In addition, statistically significant improvements or trends were noted on multiple secondary clinical endpoints.
Neflamapimod was granted Fast Track designation from the U.S. FDA in November 2019.
Neflamapimod 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-induced synaptic toxicity, leading to impairment of synaptic function. Synaptic dysfunction is known to be a major drive of the deficits in cognitive function that are defining characteristics of many CNS diseases.
About Dementia with Lewy bodies (DLB)
Dementia with Lewy bodies (DLB) is a serious disease representing 15 to 20 percent of the dementia population, with an estimated up to 1.4 million affected individuals in the US. DLB is characterized by progressive dementia and fluctuating cognition (deficits in memory and attention), sleep disturbances, visual hallucination and parkinsonism (tremor and gait disturbances). Although it is a separate disease, it can be difficult to differentiate from the related dementias of Alzheimer’s disease (AD) and Parkinson’s disease (PD). The prognosis for DLB is even more severe than that of AD with an average time from diagnosis to death of just four to seven years. There are no approved treatments for DLB.