Round up: NR Times explores the latest business developments in the world of neurorehabilitation
US$1.04bn agreement for a novel investigational Alzheimer’s therapy
Biopharma company ADEL has announced that it has entered into an exclusive worldwide license agreement with Sanofi, a multinational healthcare company, for the development and commercialisation of ADEL-Y01.
ADEL-Y01 is a potential first-in-class antibody therapy for Alzheimer’s disease, and related backup compounds.
The total potential value of the agreement is up to $1.04 billion. ADEL will receive a non-refundable upfront payment of US$80m and is eligible to receive additional payments contingent upon the achievement of specified development and commercial milestones.
ADEL-Y01 is a humanised, monoclonal antibody that selectively targets tau protein acetylated at Lysine-280 (acK280).
Unlike therapies targeting total tau, ADEL-Y01 specifically inhibits the aggregation and propagation of toxic tau species, a key driver of Alzheimer’s pathology, while preserving the function of normal microtubule-associated tau.
ADEL spearheaded the discovery and preclinical development of ADEL-Y01 using its proprietary neural disease research and development platform.
Since 2020, ADEL has been co-developing the asset through a joint research and development agreement with Oscotec Inc.
Currently, ADEL-Y01 is undergoing a global Phase 1 clinical trial under an Investigational New Drug (IND) application approved by the U.S. FDA.
“This strategic partnership with Sanofi, a global leader in healthcare, underscores ADEL’s technological strength and highlights the therapeutic promise of ADEL-Y01,” said Seung-Yong Yoon, CEO of ADEL.
“By combining our scientific expertise with the proven development and commercialization capabilities of Sanofi, we hope to accelerate the delivery of this disease-modifying therapy to people living with Alzheimer’s around the world.”
Wearable Devices Inc. receives approval for neurorehabilitation pilot
Technology company Wearable Devices, which specialises in AI-powered touchless sensing wearables, has received a grant approval from the Israel Innovation Authority (IIA) for a total budget of US$750,000.
The funding will finance a clinical pilot program in partnership with Soroka University Medical Center.
The pilot programme will seek to validate the Company’s Mudra Link neural wristband as a rehabilitation tool for patients suffering from impaired grip-force control following motor-cortex brain injuries.
Utilising patented surface neural ElectroMyography (EMG) technology, the system provides real-time, objective biofeedback to train modulation, anticipation, and correction of grip force.
“Rehabilitation and assistive technologies were always the first go-to market of Brain Computer Interface companies where the willingness to adopt new life changing solutions is naturally high,” said Guy Wagner, president and chief scientific officer of Wearable Devices.
“The Mudra platform is uniquely positioned to deliver quantifiable, engaging, and cost-effective therapy that can be performed at home with minimal therapist supervision and at much lower costs than currently available solutions.
“This pilot at Soroka Hospital, backed by the IIA, is a critical next step on the path toward establishing Mudra as the standard of care in grip-force neurorehabilitation worldwide.”
Dr. Salman Zubedat, research and development and clinical applications scientist who is leading the clinical pilot on behalf of Wearable Devices, commented: “The current standard of care in force-control rehabilitation is often subjective, relying on improvised methods without consistent, quantitative performance tracking.
“Our pilot with Soroka Hospital represents a crucial scientific step toward clinical validation.
“By leveraging the Mudra Link’s non-invasive ability to capture objective, quantitative neuro-muscular data, Mudra Link can potentially enable standardized performance metrics that will enhance clinical tools and offer unprecedented insights, with the potential to improve treatment accessibility and accelerate recovery for patients with complex neurological motor deficits.”
Grant awarded for development of novel α-Synuclein PET imaging biomarker
Enigma Biomedical USA has received a US$2m grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF).
The grant will support the discovery and initial preclinical development of a novel α-synuclein Positron Emission Tomography (PET) Imaging biomarker.
This funding is part of MJFF’s strategic research agenda focused on supporting objective tools to biologically measure and track the progression of Parkinson’s disease (PD) to improve clinical trial design.
Misfolded α-synuclein, a protein that clumps in the brains of people who live with PD, is a fundamental hallmark of the disease resulting in its symptoms.
A new staging framework aimed at defining PD and related neuronal α-synuclein diseases based on their underlying biology places conditions such as PD and dementia with Lewy bodies (DLB) along a shared continuum of progression, from disease risk to functional impairment, and underscores a standardised biological diagnosis.
The discovery research recognised by this award will be based on Nobel Prize-winning Click Chemistry and candidate screening techniques developed by Hartmuth Kolb, chief science officer at EB USA and will be conducted at the University of Wisconsin, where Dr Kolb serves as a Visiting Professor.
Dr Kolb is widely recognized as a leading expert on biomarkers for neurodegeneration, and led the team which discovered the leading first-generation Tau PET imaging biomarker
Dr. Kolb said: “We are extremely grateful to The Michael J Fox Foundation for this recognition and generous support and are excited to begin the work, which we hope will have a significant impact on improving management of this devastating disease.”
“EB USA is very pleased with our growing partnership with The Michael J Fox Foundation, who share our commitment to addressing critical unmet needs in neurodegenerative disease as well as providing tools and technologies to support the development of disease targeted therapies,” said Rick Hiatt, president and CEO of EB USA.
Prilenia and Ferrer announce FDA clearance for Phase 3 ALS trail
Prilenia Therapeutics B.V. and Ferrer today announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, randomised, placebo-controlled Phase 3 study of pridopidine in participants with rapidly progressive amyotrophic lateral sclerosis (ALS) early in their disease course.
Recruitment is planned to begin at the first US clinical trial sites in early 2026, with sites in Europe and other regions to follow, pending local clinical trial clearance.
Early detection and management are essential for preserving function, with slowing of functional decline, maintaining speech and prolonging survival being ALS therapeutic priorities. This makes pridopidine’s S1R activation mechanism of particular interest.
The study will consist of an initial 48-week double-blind placebo-controlled phase, randomised on a 3:2 (pridopidine:placebo) basis, followed by a 48-week open-label extension phase.
The primary endpoint will be the change from baseline in ALSFRS-R adjusted for mortality at 48 weeks. Secondary and exploratory endpoints will include measures of speech, respiratory function, bulbar function, quality of life and effect of pridopidine on survival, as well as patient-reported outcomes of communication and plasma biomarkers.
PREVAiLS is predicated on subgroup analyses of data from 284 subjects with rapidly progressive ALS early in their disease course from the Phase 2 HEALEY ALS Platform trial, showing potentially clinically meaningful improvements with pridopidine in multiple domains of disease progression, speech and survival.
These subgroup analyses from the HEALY ALS Platform Trial showed a 32 per cent slowing of overall progression, a 62 per cent slowing of respiratory function worsening and slowing of decline of dyspnea by 88 per cent, with articulation and speaking rate deterioration reduced by 93 per cent and 70 per cent respectively, at 24 weeks.
These data also showed a 57 per cent improvement in survival benefit for patients taking pridopidine, prolonging median survival time from 300 to 600 days and a favorable safety profile.
