Leuven Belgium, 21 October 2021: reMYND NV, a clinical stage company, is pleased to announce that it has initiated the multiple-ascending-dose (MAD) phase of its Alzheimer’s program after observing no compound-related ReS19-T adverse events so far in the 58 healthy volunteers in the single-ascending dose (SAD) phase.
The Phase I study of ReS19-T, a first-in-class small molecule which aims to restore cognition in Alzheimer’s patients, is being conducted at the Medical University of Vienna in Austria and will guide the dose range selection for a Phase IIa proof-of-concept study. The multiple-ascending dose (MAD) phase has been initiated well before the maximum tolerable dose has been reached. To date, healthy volunteers in the SAD phase have been dosed up to 700 mg, and food impact has been assessed at this high dose. Dosing with food provides an excellent bio-availability, resulting in exposure well above the anticipated therapeutic levels.
“After learning how to deal with a molecule that exerts its activity only in pathological conditions in diseased tissue and not in physiological conditions in healthy tissue, it has been exciting to challenge and closely observe such a new therapeutic concept in humans,” said Prof. Wolzt from MedUni Vienna, the principal investigator of the clinical trial in healthy volunteers.
“The Alzheimer’s field is in dire need of exploring new mechanisms. Calcium dyshomeostasis is such a promising and under-explored mechanism, mainly for safety concerns: it has been known for decades to be a fast and central process in Alzheimer’s; the caution has previously been regarding potential safety concerns when interfering with such a central process. Taking into account that interfering with calcium is a very fast process, these preliminary results, even at a single dose, indicate that we might have found a safe way of engaging with this central Alzheimer’s process,” commented Prof. Cummings, Joy Chambers-Grundy Professor of Brain Science, UNLV, USA and a member of reMYND’s Clinical Advisory Board. “The preclinical studies and early clinical trials of ReS19-T provide a strong foundation for advancing this innovative treatment. With this promising data we are getting close to a pivotal test of the calcium hypothesis in patients in 2022.”
“Every test we take further confirms our hypotheses step-by-step. As we develop our novel approach with the potential to restore function in Alzheimer’s patients, we cannot just copy existing clinical approaches,” repeated Koen De Witte, Managing Director of reMYND. He added, “Therefore, it is so great to notice the growing momentum and the increasing excitement of some of the leading thinkers and first adopters."
About reMYND’s ReS19-T Alzheimer’s program
ReS19-T is reMYND’s most advanced program, an investigational compound for the treatment of Alzheimer’s, which entered the clinic in Q4 2020. The ReS19-T candidate, a first-in-class small molecule, represents a novel approach to treat Alzheimer’s Disease, aiming to address the disease at its root and restore cognition in patients by reducing the cellular damage associated with memory loss. In animal models it has shown to produce an acute response, restoring calcium homeostasis and synaptic plasticity, a process central in the disease cascade leading to neuronal demise and build-up of plaques and tangles. It is the first in a pipeline of candidates developed using reMYND’s proprietary drug discovery platform.
The Phase I randomized, double-blind, placebo-controlled study with an adaptive dose design was launched in December 2020 in Austria and is evaluating the safety, tolerability, and pharmacokinetics of ReS19-T in healthy subjects. The trial includes both young and elderly subjects and will guide the dose range selection for the Phase IIa proof of concept study.
reMYND is a clinical stage company developing novel treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction. It is backed by a proprietary drug discovery platform, which enables the identification of novel mechanisms-of-action, targets and first-in-class small molecules.
reMYND’s most advanced program is ReS19-T, an investigational compound for the treatment of Alzheimer’s, which entered the clinic in Q4 2020. In animal models it has shown to produce an acute response, restoring synaptic plasticity, a process central in the disease cascade leading to neuronal demise and build-up of plaques and tangles. The company is also developing a treatment for diabetes, ReS39. Animal models have demonstrated the compound’s efficacy to increase endogenous insulin production capacity with a sustained and durable effect on blood glucose levels and end-organ protection.
Other treatments for major health challenges are being explored using reMYND’s discovery platform, with a focus on mitochondrial dysfunction in central nervous system (CNS) disorders.
In addition, reMYND has a dedicated Contract Research Organization (CRO), which focuses on CNS disorders. The team helps clients to assess the pharmacokinetics, pharmacodynamics and efficacy of their experimental treatments in reMYND’s proprietary animal models. The CRO has a global client base, including the US, Europe and Japan.
reMYND was founded in 2002 as a spin-off from the University of Leuven, and has been substantially supported by grants from VLAIO/IWT (Flanders, Belgium). Find out more at https://www.remynd.com.