reMYND commences first-in-human trial of ReS19-T Alzheimer’s program

Press Release

reMYND commences first-in-human trial of ReS19-T Alzheimer’s program

• RES19-T represents a novel approach to treat Alzheimer’s at the root of the disease and restore cognition
   
• Board and Senior Leadership team strengthened; appointment of Staph Leavenworth Bakali as Chair and Hermann Russ as Chief Medical Officer

Leuven Belgium, 03 December 2020: reMYND NV, a clinical stage company developing innovative treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction, today announces commencement of a first-in-human trial of its wholly owned therapeutic candidate RES19-T.

As part of its transition into a clinical stage Company, reMYND has also strengthened its Board and senior leadership team with the appointment of Staph Leavenworth Bakali as Chair of the Board and Hermann Russ as Chief Medical Officer.

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.” 

Strengthened Board and Senior Leadership Team

reMYND has strengthened its Board and senior leadership team with the appointment of Staph Leavenworth Bakali as Chair of the Board and Hermann Russ as Chief Medical Officer.

Staph Leavenworth Bakali has over 30 years of senior executive and board level experience leading, growing, and transforming large complex and start-up organizations in the global pharmaceutical, biotechnology and not-for-profit health arenas. Mr. Leavenworth Bakali has substantial experience and a proven track record in fundraising, negotiating and concluding a wide range of public and private sector agreements and partnerships, including cross border mergers and acquisitions.

He is President & Chief Executive Officer of George Health Enterprises (GHE), a London based global healthcare company. He has held senior executive and Board positions with leading pharmaceutical and biotechnology companies, including 11 years with SmithKline Beecham, living and managing businesses in established and emerging markets.

Dr. Hermann Russ is a board-certified clinical neurologist, a professor of pharmacology and a pharmacist. He holds a Ph.D. in neuro- and bio-chemistry from the University of Wurzburg, Germany. His scientific focus is on neurodegenerative diseases, including Alzheimer's, Parkinson’s, and degenerative retina diseases. He is (co)inventor of more than 25 patents and (co)author of 50 peer-reviewed scientific publications.

Dr. Russ has over 20 years of Pharma industry experience. Before joining reMYND, he was Chief Scientific Officer of US based biotech Company Galimedix. Prior to this Dr. Russ was vice president of Neuroscience Project Leadership in Specialty R&D and Managing Officer on the Board of Directors at Teva Pharmaceuticals in Switzerland. He also worked for eight years at Merz Pharma as Head of Global R&D CNS, leading in neurology and psychiatry, spanning from early discovery to clinical development and regulatory submission. From 1999 to 2007 Dr. Russ was with Merck KGaA as Head of the Medical Center of Excellence in CNS. Dr. Russ was closely involved in 8 regulatory drug approvals, including in Alzheimer’s Disease, Huntington’s Disease and movement disorders.

About reMYND

reMYND is a clinical stage company developing 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 potential 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.