Two independent TechBio companies, Indivi and Clouds of Care, announced a strategic partnership to advance precision medicine tools in early-phase neuroscience drug development, specifically targeting Alzheimer's and Parkinson's disease. The collaboration addresses one of medicine's most challenging areas, where neurodegeneration research faces historically low probability of technical and regulatory success (PTRS).
Addressing Critical Drug Development Challenges
The field of neurodegeneration presents significant hurdles for pharmaceutical development, with the highest attrition occurring between First-in-Human and Proof-of-Concept studies. According to the companies, conventional endpoints lack the sensitivity needed to detect early treatment effects during these critical phases.
"Age being the principal risk factor for neurodegenerative diseases, we are facing a global pandemic," said Michel Vounatsos, Chair of the Board of Directors of Clouds of Care. "Deep phenotyping technologies will be essential to improve drug development success in Alzheimer's and Parkinson's Disease and extend healthy brain ageing across the lifespan."
Integrated Technology Platform
The partnership will integrate world-class expertise in neuro-electrophysiology, including resting-state EEG, event-related potentials, and polysomnography, with digital health technology tools. Together, the companies aim to establish a unified R&D framework for multimodal deep phenotyping that combines biological (electrophysiology-based) and functional (cognitive and motor behavior) measures.
This technology-integrated approach is designed to deliver earlier, more definitive Proof-of-Biology (PoB) and Proof-of-Concept (PoC) signals in early drug development trials. The collaboration creates a value proposition that de-risks early clinical development by increasing the signal-to-noise ratio of PoB-PoC endpoints, thereby enhancing PTRS and potentially improving risk-adjusted Net Present Value (rNPV) while accelerating time-to-market for biopharmaceutical partners.
Regulatory Alignment
The initiative aligns with the European Medicines Agency's (EMA) recent call for updated guidelines on early Alzheimer's trials, which emphasizes the need for more responsive and clinically meaningful endpoints in early clinical phases.
"It is not just about bringing deep phenotyping technologies together," explained Shibeshih Mitiku Belachew, Chief Medical Officer of Indivi. "It is about creating a true symbiosis between clinical development and the science of enabling technologies to design smarter, faster, and more successful trials."
Company Capabilities
Indivi's Digital Health Technology Platform
Indivi, an ISO 13485 and ISO 27001-certified TechBio company headquartered in Basel, Switzerland, develops functional biomarkers derived from Digital Health Technology (DHT) tools measuring motion and cognition for neuroscience drug development trials. The company has developed the most comprehensive suite of smartphone-based assessments (N=20) of motor and cognitive functions, including Konectom, a digital biomarker platform in-licensed from Biogen in 2024.
CoGames represents Indivi's proprietary battery of smartphone-based gamified and user-adaptive cognitive assessments (ACA). The platform features a unique system of dynamic difficulty adaptation to individual performance, enabling personalized difficulty adjustment for each cognitive assessment per subject at trial baseline.
Clouds of Care's Electrophysiology Solutions
Clouds of Care NV, an ISO 13485 and ISO 27001-certified TechBio company based in Ghent, Belgium, houses CE-marked and FDA-cleared electrophysiology applications for clinicians and provides tailor-made clinical development solutions for biopharmaceutical companies. Through its comprehensive CNS platform and strategic network of partners, the company focuses on revolutionizing care for people with Central Nervous System disorders.
The company's resting-state EEG technology measures direct and indirect effects of active compounds on brain activity during wakefulness and sleep, serving as a pharmaco-dynamic readout of therapeutic response at the neuronal biology level. Event-related potentials (ERPs), recorded using scalp EEG, offer a non-invasive, high-temporal-resolution method for assessing cognitive and socio-emotional neuronal activity in response to sensory and cognitive stimuli.
Clouds of Care's proprietary Electrical Source Imaging (ESI) estimates the 3D spatial distribution of brain activity source localization using an electromagnetic model built from subject-level brain MRI. This capability is essential for capturing spatially heterogeneous disease signatures observed in Alzheimer's and Parkinson's diseases, with ERPs' sensitivity to subtle neural changes making them valuable PoB endpoints for early-stage clinical trials.
