Lottie file
Innovatie
Novel drug candidate for Alzheimer's
Opschaling
We have developed an innovative drug design technology, which we are now applying to a critical target in Alzheimer's Disease (AD) pathology. Our decision is driven by our commitment to addressing urgent societal health challenges such as AD. The results are promising, and we are confident that our technology holds great potential.
Medisch technologische innovaties
Regio Noord-Holland
Help ons versnellen
To accelerate our Alzheimer’s drug development, we seek: Funding for Trials: Financial support to advance from preclinical research to clinical trials; Access to Facilities: Partnerships for lab space and specialized equipment to enhance testing; Expertise: Guidance from neuroscientists and regulatory experts for trial design and compliance; Community Engagement: Collaboration with patient advocacy groups for trial awareness and recruitment; Support in these areas will expedite our path to delivering impactful Alzheimer’s treatments.
Ewelina Weglarz-Tomczak
Probleemstelling
Alzheimer’s disease (AD) is a devastating, progressive neurodegenerative disease that causes impaired cognitive function and memory loss, often combined with psychiatric symptoms such as personality changes, and eventually leads to dementia and death of the patient .According to the World Health Organization (WHO), there are approximately around 50 million people worldwide (15 million in Europe) living with AD or a related form of dementia, and this number will increase in the coming years, outpacing the health and social care resources needed to manage it and becoming a major public health concern. Every three seconds, someone in the world develops AD/dementia. AD and other forms of dementia are now among the top 10 causes of death worldwide, ranking 3rd in both the Americas and Europe in 2019. AD accounts for the second highest prevalence worldwide and is regarded as one of the costliest diseases to society. Undoubtedly, AD is a growing global health challenge affecting not only patients but also their families, friends and whole society having catastrophic healthcare, economic, and social impacts. AD and dementia are estimated to collectively cost Europe €460 billion while global costs are estimated at €1.5 trillion [3,6]. According to the Ministry of Health, Welfare and Sport ("National Dementia Strategy 2021-2030"), healthcare costs for dementia will increase from 6.6 billion euros in 2015 to 15.6 billion euros in 2040 in the Netherlands. These costs are associated with social care, and informal care costs due to loss of productivity by both patients and caregivers. At most as 42% are attributed to indirect/informal costs, in the form of unpaid work of informal caregivers (e.g., family members and friends), which could mean loss of productivity as well as a reduction in financial savings what is major social concern. The same number (42%) is attributed to social/non-medical costs (e.g., community and social services, private and public funding care, homecare, special accommodations, pension income, welfare support, and household expenses). Other 16% of the vast financial costs of AD are attributed to medical costs (e.g., medical practitioner visits, hospital care, medical treatment, etc.)
Oplossing
The demand for new generation therapeutics that can slow or halt the progression of AD is both great and urgent. To slow or halt AD, we need to find effective drugs that can suppresses or stop the progression of the diseases by targeting its underlying cause(s). These drugs are often called ‘disease-modifying' treatments. At present, there are no disease-modifying treatments available for any type of dementia, including AD. Furthermore, a paradigm shift of AD drug development from the single-target strategy to a two-target strategy can dramatically increase the chance of developing effective AD drugs and be the game changer in the drug development program for AD. In addition, only high safety profile of drugs will enable the clinical use. Our approach to delivering a new class of anti-AD drugs is completely innovative and has never been applied before to any of medically relevant proteases or other targets toward AD or other diseases. As a result of our research, we have created a novel de novo drug design methodology for AD-relevant protease. This choice was made based on the importance, full understanding of the molecular mechanism of catalysis and social importance. It led us to the discovery of the principles of the natural regulatory mechanisms of targeted protease. We found structures that have never been described or considered as natural regulators/inhibitors. As today, there is no other research (published) that possess this knowledge. Further, we can develop highly effective and safe inhibitors and further drugs against AD.
VWS-missies
At NatInLab, we are deeply committed to enhancing treatments for neurodegenerative diseases like Alzheimer’s and Dementia, aligning closely with the Ministry of Health, Welfare, and Sport (VWS) missions, particularly Missions I and IV. As we move toward 2030, our objective is to contribute significantly to the National Dementia Strategy, which aims to improve the quality of life for people with dementia by 25%.
Our innovative approach centers on leveraging advanced AI-driven virtual screening and Bayesian inference to develop tailored diagnostic and therapeutic solutions. This aligns with Mission I’s focus on research aimed at prediction, prevention, and personalized treatment, with a goal that by 2025, every individual with dementia will have access to a customized diagnosis and treatment plan. Our technology allows for early biomarker detection and refined diagnostics, which is essential for enabling timely interventions and personalized care pathways. This proactive approach not only aims to reduce symptom severity but also to enhance social participation—one of the key objectives of the National Dementia Strategy, which seeks to ensure that 80% of community-dwelling individuals with dementia have access to meaningful activities by 2030. Our approach and ambitions of a new class of preventative therapeutics is key to contributing to that.
Furthermore, NatInLab’s innovations directly support Mission IV, which emphasizes the importance of quality of life and self-reliance for individuals living with dementia. Our AI-based platform not only focuses on diagnosis and treatment but also equips patients and their caregivers with the necessary tools to manage symptoms effectively, promoting independence and dignity. This resonates with the WOZO principles of self-care, home-based support, and digital solutions, ensuring that innovations are designed with the involvement of caregivers throughout the process.
We also recognize the critical role of collaboration across sectors to achieve these goals. By working with partners in the Life, Science & Health sectors, as well as industries focused on healthy living and technological innovations, we aim to contribute towards the creation of a comprehensive support system for individuals with dementia and their families.
In summary, NatInLab’s commitment is not merely a scientific breakthrough; it reflects a holistic approach to a future where neurodegenerative diseases are met with proactive, patient-centered solutions. By aligning closely with VWS Missions I and IV and the National Dementia Strategy, we strive to make early detection and enhanced quality of life a reality for individuals with Alzheimer’s and dementia, supporting a vision of health that embodies autonomy, social participation, and resilience within the aging population
Doelgroep
For an anti-Alzheimer's therapeutic approach, the target audience is primarily:
Patients with Alzheimer’s Disease (AD):
Specifically, people diagnosed with Alzheimer’s disease, including those at early stages (mild cognitive impairment or early-stage Alzheimer's), are the primary audience. This group currently consists of approximately 6 million people in the United States and an estimated 55 million worldwide—a number projected to triple by 2050 due to aging populations.
High-Risk Individuals and Caregivers:
High-Risk Individuals: People over age 65 who are at a heightened risk of Alzheimer’s, including those with a family history or genetic predispositions (such as the APOE4 allele). In the U.S. alone, the population aged 65 and older is around 56 million, with about 10-20% considered high-risk.
Caregivers and Families: Alzheimer’s profoundly affects not only patients but also their families and caregivers. With each Alzheimer’s patient, caregivers also bear significant physical, emotional, and financial burdens. There are approximately 11 million caregivers for Alzheimer's patients in the U.S. alone. Providing them with resources and support is crucial, and they are also a secondary audience for education and intervention products.
Estimating Market Size for Anti-Alzheimer's Innovations:
Immediate Market Size:
The immediate market includes the 55 million people currently living with Alzheimer’s worldwide. Due to the lack of effective curative treatments, there is high demand and urgency within this population for innovative therapies. In monetary terms, the global Alzheimer’s treatment market is valued at approximately $3 billion and is expected to grow substantially in the coming decade.
Future Market Growth:
With aging demographics globally, particularly in developed countries, this target market is anticipated to expand rapidly. By 2050, the Alzheimer's population could reach 139 million, meaning an anti-Alzheimer’s treatment could address an exponentially growing need. This growth underscores the importance of long-term therapeutic and preventive solutions.
Broad Societal and Healthcare Impact:
The reach of an anti-Alzheimer’s treatment also extends to healthcare systems and insurance providers, given the high cost associated with long-term Alzheimer’s care. In the U.S. alone, Alzheimer’s and dementia-related care cost over $300 billion annually, making innovative treatments economically appealing to both healthcare systems and insurance providers.
In summary, the primary target audience for an anti-Alzheimer’s innovation is the current Alzheimer’s patient population of 55 million worldwide. Including high-risk individuals and caregivers, the extended audience could reasonably be over 100 million people globally, with future growth driven by demographic aging.
Verlaging zorgkosten
An anti-Alzheimer’s innovation can reduce healthcare costs in several impactful ways:
1. Delaying Disease Progression
By slowing or halting Alzheimer’s progression, the innovation could help patients maintain independence longer, reducing the need for full-time caregiving and delaying entry into long-term care facilities. This has significant cost implications because residential care and nursing home expenses are among the highest healthcare costs for Alzheimer’s patients, with an average annual cost in the U.S. ranging from $60,000 to over $100,000.
2. Reducing Hospitalizations and Complications
Alzheimer’s patients are more likely to experience complications, falls, and other health issues that lead to costly hospital visits. An effective treatment can lower the frequency and severity of these events, reducing associated hospital admissions, emergency room visits, and rehabilitation costs. For instance, people with Alzheimer’s are hospitalized twice as often as those without dementia; reducing this rate could lead to substantial savings.
3. Minimizing Caregiver Burden and Associated Healthcare Costs
Family caregivers for Alzheimer’s patients often experience high levels of stress, resulting in their own increased healthcare costs due to stress-related conditions like depression, anxiety, and physical ailments. By reducing the severity of Alzheimer’s symptoms, an innovation can help alleviate some of this caregiver burden, improving their quality of life and lowering their healthcare utilization and costs.
4. Lowering Outpatient Care and Pharmaceutical Expenses
Alzheimer’s patients generally require ongoing medical management and multiple prescriptions to address cognitive symptoms and associated behavioral issues (e.g., agitation, depression). A treatment that effectively targets Alzheimer’s could lower the demand for these supportive medications and reduce the frequency of specialist visits, diagnostic tests, and therapy, leading to substantial savings.
5. Postponing or Reducing Institutionalized Care Needs
Institutionalized care is among the most expensive components of Alzheimer’s disease management. If an anti-Alzheimer’s treatment can reduce the rate at which patients enter advanced stages, healthcare systems will see reduced costs associated with nursing home and hospice care. Even a modest delay of progression to severe stages could lead to savings of billions annually across healthcare systems.
Estimated Economic Impact
By delaying the disease’s progression and reducing associated complications, innovations targeting Alzheimer’s could save billions each year. For example, according to recent estimates, a treatment that delays onset by five years could reduce care costs by up to $600 billion in the U.S. alone over the next few decades. This underscores the potential for an Alzheimer’s innovation not only to improve patient and caregiver lives but also to contribute significantly to the sustainability of healthcare systems worldwide.
Verdienmodel
To capitalize on the anti-Alzheimer’s innovation effectively, the business model would combine elements of partnership-based funding, milestone payments, and licensing. This approach can attract larger pharmaceutical partners for late-stage trials and commercialization, thus sharing risk and expense. Given a 20 million euro budget up to first-in-human (FIH) trials, the business model for this anti-Alzheimer’s innovation would likely focus on establishing partnerships to support further development, regulatory approvals, and eventual commercialization.
Given the global demand for Alzheimer’s treatments, a successful therapy can achieve blockbuster status, potentially generating billions annually. For example, even a modest royalty rate of 10% on global sales could yield significant returns. If the treatment addresses a portion of the Alzheimer’s patient population (e.g., 5 million patients globally at €5,000/year per patient), annual revenue could potentially exceed 2 billion euros, with royalties of 200 million euros per year.
Geïnvesteerd vermogen
€ 100 duizend-1miljoen
Concurrentie
In the field of Alzheimer’s treatment, the biggest competition includes established pharmaceutical companies and biotech firms working on similar solutions, such as Eli Lilly, Biogen, Roche, and other companies researching both symptomatic treatments and disease-modifying therapies. Additionally, there are non-pharmaceutical approaches to Alzheimer’s care that indirectly compete by managing symptoms and providing caregiving support.
Current Solutions for Alzheimer’s Disease
Symptomatic Treatments
Current treatments, such as donepezil, rivastigmine, and memantine, primarily focus on symptomatic relief, slowing down cognitive decline temporarily but without addressing the underlying causes of Alzheimer’s. Recently approved drugs like aducanumab (Biogen) and lecanemab (Eisai and Biogen) target amyloid plaques, a hallmark of Alzheimer’s pathology, but their effectiveness and impact on disease progression remain limited and controversial due to high costs, modest efficacy, and side effects.
Caregiving and Support Services
Without effective disease-modifying treatments, most Alzheimer's care depends on family caregivers, assisted living facilities, and nursing homes. These approaches are costly, with annual expenses for institutionalized care ranging from $60,000 to over $100,000 per patient, and they do not slow the disease's progression. Caregiver burden also contributes to increased healthcare costs due to stress and health issues among caregivers.
Clinical Trials in Progress
Numerous other companies and research institutions are investigating Alzheimer’s therapies that target amyloid or tau proteins, neuroinflammation, neuroprotection, and other mechanisms.
This innovation reduces healthcare costs by:
Delaying Institutional Care: Patients stay independent longer, reducing the need for costly nursing homes.
Lowering Hospital Visits: Fewer complications mean fewer hospitalizations and ER visits.
Reducing Caregiver Costs: Slower decline eases caregiver stress, lowering their healthcare expenses.
Cutting Medication Costs: Less reliance on expensive, ongoing symptomatic drugs reduces overall treatment costs.
In short, it promotes independence, reduces hospitalizations, eases caregiver burden, and lowers medication reliance, leading to significant long-term savings.
Unieke kenmerken
This innovation stands out as a first-in-class, disease-modifying treatment for Alzheimer’s, targeting the root causes rather than just symptoms. Unlike existing treatments that focus on a single aspect of Alzheimer’s pathology (like amyloid plaques), it takes a multipathology approach, addressing multiple mechanisms simultaneously—such as amyloid, tau, neuroinflammation, and neuroprotection. This comprehensive strategy aims to slow or even reverse disease progression, making it a groundbreaking shift from symptom management to altering the disease’s course.
Intellectueel eigendom
The intellectual property (IP) for this innovation lies in the novel molecule designed specifically as a multipathology approach for Alzheimer’s disease. This molecule targets multiple pathological mechanisms involved in Alzheimer’s, making it unique. Key features of the molecule that contribute to the IP include:
Unique Structure and Mechanism of Action: The molecule’s structure is designed to interact precisely with multiple Alzheimer’s-related pathways—such as amyloid plaque reduction, tau stabilization, and neuroinflammation reduction. This distinct, multi-target mechanism is patentable and forms the core of the IP.
First-in-Class Status: As a disease-modifying agent rather than a symptomatic treatment, this molecule is pioneering in its class. Its combination of targets and effects has not been seen in existing Alzheimer’s drugs, giving it significant novelty and competitive advantage.
Potential for Broad Neuroprotective Effects: The molecule’s design includes neuroprotective properties that could extend its application to other neurodegenerative conditions, broadening the IP value. This feature differentiates it further in the Alzheimer’s treatment landscape.
These elements make the molecule and its multi-target approach highly innovative and provide a strong basis for IP protection.
Organisatie
1. Type of Organization:
A biopharmaceutical startup focused on developing innovative drugs for neurodegenerative diseases, particularly Alzheimer’s.
2. Organizational Structure:
Flat Structure: Encourages open communication and rapid decision-making.
Key Departments:
R&D: Drug discovery and clinical development.
Clinical Operations: Managing clinical trials.
Regulatory Affairs: Ensuring compliance.
Commercialization: Market entry strategies.
Finance/Admin: Financial management.
3. Expected Size:
Initial Team: 10-20 skilled professionals.
Growth Projection: 50-100 employees within 3-5 years as the company advances through clinical trials and prepares for commercialization.
4. Collaboration:
Partnerships: Actively seek collaborations with academic institutions and pharmaceutical companies for resources and expertise.
Investor Relations: Engage venture capital and angel investors for funding.
5. Culture and Vision:
Emphasis on innovation and agility, fostering a collaborative environment.
Aim to become a leader in developing effective treatments for neurodegenerative diseases.
In summary, the startup will be a dynamic, innovative organization dedicated to delivering groundbreaking therapies for neurodegeneration, with a small, agile team and a strong focus on collaboration and growth.
Beschrijving pilotfase
Testing Approach for the Innovation
The product is being tested through several methodologies:
Isolated Targets:
Initial evaluations on isolated molecular targets related to Alzheimer’s, such as amyloid plaques and tau proteins, to assess efficacy.
Cell Lysate Studies:
Use of cell lysates to study the drug's biochemical effects and identify potential off-target interactions.
Cell Models of Alzheimer’s Disease:
Testing in cell lines to observe impacts on cell health, function, and pathology reduction.
Basic Toxicity Studies:
Conducting initial toxicity tests to ensure safety, focusing on cell viability and potential cytotoxic effects.
Summary
This comprehensive approach allows for thorough assessment of the drug’s efficacy, mechanism of action, and safety profile prior to in vivo studies and clinical trials
Betrokken partners
Involvement of Partners
Several key partners have been involved in the development and testing of the innovation:
University of Amsterdam (UvA)
Role: Collaboration with the University’s Molecular Neuroscience Group at the Swammerdam Institute for Life Sciences (SILS) to leverage their expertise in neurobiology and drug development. They contribute to basic research, experimental design, and data analysis.
Amsterdam Neuroscience
Role: This research institute supports the project by providing access to a network of researchers and facilities. Their involvement enhances the integration of neuroscience research and clinical applications, facilitating advancements in understanding Alzheimer’s disease mechanisms.
Amsterdam AI Solutions
Role: Partnering with Amsterdam AI Solutions to incorporate artificial intelligence in data analysis and modeling. Their expertise helps optimize drug discovery processes, including predicting molecular interactions and outcomes based on large datasets.
IXA (Innovation Exchange Amsterdam)
Role: IXA plays a crucial role in facilitating partnerships and funding opportunities. They help bridge the gap between academic research and industry, ensuring that the innovation has the necessary support for commercialization.
Province of Noord-Holland
Role: The provincial government supports the initiative through funding and resources aimed at fostering innovation in health and biotechnology sectors. Their involvement helps ensure the project aligns with regional health priorities and access to public resources.
Summary
These partnerships provide vital resources, expertise, and support in research, data analysis, AI integration, commercialization strategies, and funding, all of which are crucial for the successful development of the innovative treatment for Alzheimer’s disease.
Onderzoeksresultaten
The pilot study yielded several significant results, most notably:
Reduction in Beta-Amyloid Production:
The innovation demonstrated a marked decrease in the production of beta-amyloid, a key pathological hallmark of Alzheimer’s disease. This reduction indicates the potential effectiveness of the treatment in addressing one of the primary drivers of the disease.
Improvement in Cellular Health:
Treated cell models showed enhanced neuronal viability and reduced signs of cellular stress, suggesting that the drug not only targets amyloid production but also promotes overall neuronal health.
Modulation of Inflammatory Markers:
The study observed a decrease in neuroinflammatory markers, indicating that the treatment may help mitigate inflammation associated with Alzheimer’s pathology.
Safety Profile:
Basic toxicity assessments revealed a favorable safety profile, with no significant cytotoxic effects on neuronal or non-neuronal cells, supporting further development for clinical trials.
Implementatiestrategie
1. Development and Testing:
Preclinical Research: Continue studies to assess efficacy, safety, and dosing.
Clinical Trials: Conduct phased clinical trials to evaluate safety and effectiveness in humans.
2. Regulatory Approval:
Engagement: Maintain communication with regulatory authorities (e.g., FDA, EMA) for compliance and submission of IND and CTA applications.
Data Submission: Compile and submit trial results for regulatory approval, focusing on safety and efficacy.
3. Strategic Partnerships:
Pharmaceutical Collaborations: Partner with larger companies for funding and resources during later-stage trials.
Healthcare Institutions: Collaborate with hospitals for trial sites and data collection.
4. Market Access:
Health Economics Research: Conduct studies to demonstrate economic value, aiding discussions with payers.
Stakeholder Engagement: Raise awareness among healthcare providers and patient advocacy groups.
5. Commercialization:
Launch Plan: Develop marketing and distribution strategies to reach providers and patients.
Patient Education: Implement initiatives to inform patients and caregivers about the treatment.
6. Continuous Monitoring:
Post-Market Surveillance: Monitor long-term efficacy and safety through post-marketing studies.
Feedback Mechanisms: Gather input from providers and patients for ongoing improvements.
Path to End Users
The innovation reaches patients through healthcare providers who prescribe it, with distribution via pharmacies and educational initiatives to inform patients and caregivers about its benefits.
Summary
This strategy ensures the innovation effectively transitions from development to the hands of Alzheimer’s patients, focusing on rigorous testing, regulatory compliance, partnerships, market access, and continuous improvement.
Behaalde prestaties of gewonnen awards
Selected Achievements
Proof of Concept (POC) from IXA:
Secured a Proof of Concept from the Innovation Exchange Amsterdam (IXA), validating the innovative approach and providing a foundation for further development.
Faculty of Impact Grant from NWO:
Awarded the Faculty of Impact grant from the Netherlands Organization for Scientific Research (NWO), supporting research initiatives that have a positive societal impact, particularly in neurodegenerative disease treatment.
Finalist in the Amsterdam Innovation Award:
Recognized as a finalist in the Amsterdam Innovation Award, highlighting the project’s potential and innovative approach within the biopharmaceutical sector.
Venture Challenge Grant:
Received a Venture Challenge grant, which offers funding and support for innovative startup projects, aiding in the commercialization process
Productontwikkeling
Enhanced Formulation:
Extended Release Options: Develop formulations for extended-release, improving patient compliance.
Combination Therapy: Explore combining the primary treatment with other agents to target multiple Alzheimer’s pathways.
Personalized Medicine Approach:
Biomarker-Driven Treatment: Use biomarker assessments to personalize treatment plans.
Genetic Testing Integration: Offer genetic testing to identify patients likely to respond better to the treatment.
Digital Health Integration:
Mobile App Support: Develop an app for monitoring adherence, tracking symptoms, and providing educational resources.
Telehealth Features: Include remote consultation capabilities for ongoing patient support.
Expanded Indications:
Broader Neurodegenerative Applications: Investigate potential use for other conditions like Parkinson’s disease.
Improved Delivery Mechanisms:
Alternative Delivery Systems: Research methods such as transdermal patches or intranasal formulations for better bioavailability.
Patient and Caregiver Resources:
Educational Programs: Create materials and programs for patients and caregivers about Alzheimer’s management.
Support Groups: Establish online communities for patients and caregivers to share experiences
Internationale ambitie
The company is focused on expanding internationally in Europe and the USA through strategic partnerships, global networking, and engagement with regulatory bodies to deliver its innovative Alzheimer’s treatment to a wider audience.