reMYND NV, a clinical stage company tackling neurodegeneration, today announces that its lead Alzheimer program ReS19-T has successfully completed its Phase 1 study. Topline data has demonstrated excellent brain exposure and strong safety profile. These results support the next phase of clinical development, a Phase 2a proof-of-mechanism study slated for initiation soon.
The Phase 1 study investigated RES19-T in 77 healthy volunteers, with doses up to 2 × 700 mg/day for seven days. Cerebrospinal fluid (CSF) exposure in elderly volunteers was well above the anticipated therapeutic levels, dose-linear, stable over 24 hours, and with less than 12% variation between subjects and genders.
Based on this data, reMYND will accelerate the clinical trial application for its Phase 2a proof-of-mechanism study with leading centers in the Netherlands and Spain. The study will cover placebo, low-dose and high-dose, with the low dose already providing sustained brain concentrations throughout the day, above what would be therapeutically required. The Phase 2a results are expected by mid-2023.
reMYND’s ReS19-T program is a first-in-class small molecule with the potential to combine disease modification and fast restoration of synaptic plasticity by addressing the disease at its root.
“I have been following the reMYND program now for several years, and every test so far confirms their hypothesis. This is exactly the type of program the Alzheimer’s field needs: a novel approach, based on a sound scientific rationale to potentially restore symptoms and modify the disease in sporadic Alzheimer’s. The pre-clinical data and Phase 1 data could not look better. There are good reasons to believe that this compound could address the issue as to why previous Alzheimer treatments have failed. But in the end, the real proof will only be in the Phase 2a results, which I look forward to seeing by mid-2023.” commented Prof. Henrik Zetterberg, the leading AD biomarker expert and a member of reMYND’s Clinical Advisory Board.
“I have been pleased to see the growing enthusiasm of leading opinion leaders and clinicians to start administering our investigational treatment for the first time to their patients, after having rowed upstream for so many years,” commented Koen De Witte, Managing Director of reMYND, adding: “Knowing our extensive pre-clinical efficacy data when we entered clinical development, we considered the major hurdles to demonstrating clinical efficacy were off-target side effects and insufficient brain exposure, which now have been overcome by the compound being safely delivered into the brain.”