Pharma and business round up: Advancing treatment for dementia, phase 2 trial for Alzheimer’s treatment and more
NR Times explores the latest pharma and business developments in business in the world of neuro-rehab.
Roche to advance Phase III development for early-stage Parkinson’s disease treatment
Roche has confirmed it will be advancing to the Phase 3 development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson’s disease.
Multiple endpoints from the previous PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease.
The treatment showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance.
Roche says that positive trends towards reduced motor progression at two years were observed and that these effects appear to be sustained over longer treatment periods based on additional OLE data.
The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology.
The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson’s disease, are ongoing.
Partnership to advance preclinical modeling of treatment for frontotemporal dementia
Biopharmaceutical company Psilera is joining with organ-on-a-chip technology company, Hesperos, to advance Psilera’s lead compound – PSIL-006 – into preclinical development.
The compound targets frontotemporal dementia (FTD).
FTD is a progressive neurodegenerative disorder with limited treatment options.
The integration of next-generation neuroplastogen, PSIL-006, with Hesperos’ advanced biological platform aims to develop targeted treatments to address this unmet medical need.
The partnership leverages Hesperos’ proprietary human-on-a-chip platform, which integrates patient-derived induced pluripotent stem cells (iPSCs) into interconnected, multi-organ systems.
This advanced modeling approach enables precise evaluation of drug efficacy and safety, recently touted by the FDA to reduce reliance on animal testing and expedite clinic-ready datasets.
Hesperos’ platform replicates human physiological responses, providing data on drug interactions across multiple organ systems.
The platform has so far supported multiple Investigational New Drug (IND) and Orphan Drug Designation (ODD) applications.
Results from Psilera’s preclinical modeling are expected in Q3 2025.
Jazz Pharmaceuticals presents Phase 4 data on narcolepsy treatment at SLEEP 2025
Jazz Pharmaceuticals has shared Phase 4 data evaluating the treatment benefits of Xywav – an oral solution of calcium, magnesium, potassium, and sodium oxybates – in people with narcolepsy.
According to the company, Xywav is the only low-sodium oxybate approved by the US Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy and for adults with idiopathic hypersomnia.
Richard Kovacs, chief medical officer at Jazz Pharmaceuticals says the results from its XYLO study reinforce the importance of monitoring cardiovascular indicators, including blood pressure, and the need to minimise exposure to excess sodium in this at-risk population.
Global Phase 2 trial launched for first drug targeted at autolysosome pathway for Alzheimer’s Disease
Biotechnology company Merry Life Biomedical Company has confirmed the launch of its global Phase 2 clinical trial for TML-6 – a novel oral small molecule drug targeting early-stage Alzheimer’s disease (AD).
The drug combines multiple mechanisms, including anti-oxidative effects (Nrf2 activation), melioration of autophagy function (autolysosomal activation), anti-amyloid accumulation (β-amyloid clearance), and anti-inflammatory effects (through NF-κB inhibition) through autolysosome pathway in neurons and microglia to remove intraneuronal and extracellular amyloid accumulation.
Merry Life Biomedical says the treatment represents the first in human multi-target strategy for AD treatment.
According to the company, the Phase I trial showed positive safety, tolerability, and pharmacokinetics results at 100 to 200 mg in both healthy and elderly adults.
TML-6 will now advance to a Phase II 19 site trial across the United States, Sweden, and Taiwan after FDA approval.
The 12-month study will enroll 210 patients with mild cognitive impairment (MCI) or mild dementia.
US$80m raised to advance sleep apnoea nasal spray
Mosanna Therapeutics has raised US$80m to advance its sleep apnoea nasal spray – an easy-to-use nighttime nasal spray that aims to restore the body’s natural airway control.
The financing was led by EQT Life Sciences and Pivotal bioVenture Partners, along with Forbion, Broadview Ventures and Norwest as co-lead investors. Returning investors included founding investor Forty51 Ventures as well as Supermoon Capital and High-Tech Gründerfonds (HTGF).
Daniela Begolo, managing director at EQT Life Sciences, who will be joining the board of directors, said: “What sets Mosanna apart is its fundamentally different approach to sleep apnea, treating it as a neurological and muscular dysfunction rather than a purely mechanical issue.”
“MOS118 is the first therapy with the potential to restore the body’s natural airway reflex with the simplicity of a nasal spray. MOS118 has the potential to dramatically improve adherence and outcomes in a patient population that has long been underserved.”
MOS118 targets the upper airway muscles that are responsible for maintaining airway patency.
Research has shown that in OSA patients, the natural airway reflex becomes less active at night, leading to a loss of airway patency and the occurrence of apnoea.
The new funding will support the advancement of MOS118 through Phase 2 development while also supporting the expansion of Mosanna’s pipeline.
PoNSTEP study results presented at Consortium of Multiple Sclerosis Centers Annual Meeting
Neurotech company Helius Medical Technologies has presented positive results from the PoNS Therapeutic Experience Program (PoNSTEP) study for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
The presentation highlighted the importance of treatment adherence as a key requirement for achieving a clinically meaningful improvement in gait disability over 14 weeks of therapy and its sustained therapeutic effect well into six months after the end of treatment.
The study results confirm controlled and real-world clinical evidence of PoNS Therapy’s long-term benefits already reported in people with balance deficit due to traumatic brain injury (TBI).
Antonella Favit-Van Pelt, Helius’ chief medical officer, said: “The results from this study were received with great interest as they provide the first clinical trial evidence of the long-term therapeutic benefits of PoNS Therapy for functional rehabilitation in the MS population.
“We were excited to engage with both US healthcare professionals and Canadian MS specialists and offer additional insights on the body of clinical and mechanistic evidence of PoNS Therapy’s effect in MS.
“We are encouraged by the growing recognition of the importance of PoNS’ direct effect on the central nervous system and its targeted mechanism of action as well as how it correlates with a lasting and sustained effect on gait rehabilitation, especially when comparing PoNS Therapy to other interventions limited to peripheral neuromuscular or transcutaneous stimulation.”
Collaboration to advance translational research in Alzheimer’s Disease
A new collaboration between Alamar Biosciences,, the Alzheimer’s Disease Data Initiative and Gates Ventures aims to generate one of the largest proteomic datasets linked to clinical outcomes in Alzheimer’s Disease (AD).
The international project will profile over 40,000 plasma samples representing AD and related dementias using Alamar’s ultra-sensitive NULISA technology, with the goal of accelerating biomarker discovery and driving new insights into the progression and treatment of AD.
As part of the initiative, Alamar’s NULISAseq CNS Disease Panel 120 and Inflammation Panel 250 will be implemented at research centers in the United States, Sweden, United Kingdom, and India.
These panels deliver unparalleled sensitivity and specificity, enabling the accurate measurement of hundreds of brain- and immune-related proteins from just a small volume of blood or cerebrospinal fluid.
A key feature of the CNS panel is its unique ability to distinguish brain-derived phosphorylated tau from total phosphorylated tau in blood, a critical advancement for the development of community-based screening programmes.
The resulting proteomic data will be integrated with clinical and longitudinal outcome measures and shared with the global research community by leveraging the Global Neurodegeneration Proteomics Consortium’s (GNPC) secure data-sharing processes.
Leveraging AI for Alzheimer’s Disease research
AI tech company Tempus AI is embarking on a multi-year collaboration with The Abrams Research Center on Neurogenomics at Northwestern University Feinberg School of Medicine which aims to harness AI for rapid discovery and innovation in Alzheimer’s disease research.
The collaboration will leverage Tempus’ AI-powered data analytics platform, Lens, to analyse and restructure the Center’s repository of genomic data.
The Center and Tempus teams will work to uncover genomic patterns that have the potential to advance the understanding of Alzheimer’s disease, investigate the gene and cell types affected, enable the development of new therapeutics, and accelerate the creation of novel clinical applications.
The collaboration aims to generate actionable insights that drive the discovery of targeted therapies and significantly improve patient outcomes.
