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."