reMYND NV, a clinical stage company developing innovative treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction, announces commencement of a first-in-human trial of its wholly owned therapeutic candidate RES19-T.
RES19-T, a first-in-class small molecule, represents a novel approach to treat Alzheimer’s Disease (AD), aiming to address the disease at its root and restore cognition in patients by reducing the cellular damage associated with memory loss. ReS19-T is the first in a pipeline of candidates developed using reMYND’s proprietary drug discovery platform, which identifies disease-modifying small molecule treatments and their novel target and mechanism of action to counteract the toxicity that leads to cellular dysfunction. reMYND has a broader pipeline of novel programs in development, with a diabetes program scheduled to begin in-human trials in mid-2021.
Prof. Philip Scheltens, MD, PhD, Neurologist and CEO of the Alzheimer Center Amsterdam commented “I am very pleased to see this program enter the clinic. The reMYND team has been meticulous in their research, focussing on fundamental cellular processes related to neurodegeneration in Alzheimer’s, resulting in this novel and differentiated approach.
“Our hope, backed by promising pre-clinical and animal data, is that restoring calcium homeostasis, a process central in the Alzheimer’s disease cascade, will result in a reduction in synaptic damage and translate into improvement in function and biomarkers in patients. This is an important line of enquiry into this devastating disease and we look forward to learning more as the study progresses.”
The trial, a phase I randomized, double-blind, placebo-controlled study with an adaptive dose design, will evaluate the safety, tolerability, and pharmacokinetics of ReS19-T in healthy subjects.
Studies in AD have shown that loss of memory is most closely linked to loss of synaptic plasticity, leading to neuronal degeneration. In four different preclinical models, ReS19-T has shown to robustly restore synaptic plasticity with an acute response and improve inflammation and AD pathology over a longer treatment duration, providing changes in recognized biomarkers for clinical translatability to symptomatic relief as well as disease modification.
Koen De Witte, Managing Director of reMYND commented “This is an exciting time for reMYND as we enter the clinic for the first time, representing a great step forward in our journey. Our vision is to develop new medicines which go beyond symptom relief and are able to restore function in diseases caused by cellular dysfunction, with Alzheimer’s and diabetes as our two most advanced programs. We believe our unique drug discovery platform enables us to identify novel small molecules which will allow us to address the root of these diseases, counteracting and potentially reversing the damage caused by cellular dysfunction. The exceptional group of people we have been able to rally around our platform and programs as we move into the clinic speaks volumes about the quality and potential of the work we are doing.”