Medera Announces Publication of Study Utilizing Machine Learning to Enhance Next-Generation Drug Screening with Human mini-Heart Technology
Medera announced the publication of a study in Pharmacological Research demonstrating how its subsidiary Novoheart is using AI and machine learning to enhance drug screening with human mini-Heart technology. The study achieved an 86.2% predictive accuracy in classifying drug effects, addressing the challenge of high failure rates (over 90%) in clinical trials that result in development costs exceeding $2 billion per drug. The innovative approach combines AI/ML with multiple human mini-Heart screening assays to improve drug classification capabilities, potentially reducing costs and enhancing safety in drug development.
Medera ha annunciato la pubblicazione di uno studio nella Ricerca Farmacologica che dimostra come la sua sussidiaria Novoheart stia utilizzando l'IA e il machine learning per migliorare lo screening dei farmaci con la tecnologia del mini-cuore umano. Lo studio ha raggiunto un 86,2% di accuratezza predittiva nella classificazione degli effetti dei farmaci, affrontando la sfida degli elevati tassi di fallimento (superiori al 90%) nelle sperimentazioni cliniche, che comportano costi di sviluppo superiori a 2 miliardi di dollari per farmaco. L'approccio innovativo combina IA/ML con più saggi di screening del mini-cuore umano per migliorare le capacità di classificazione dei farmaci, potenzialmente riducendo i costi e aumentando la sicurezza nello sviluppo farmaceutico.
Medera anunció la publicación de un estudio en Investigación Farmacológica que demuestra cómo su subsidiaria Novoheart está utilizando IA y aprendizaje automático para mejorar el screening de fármacos con la tecnología de mini-corazones humanos. El estudio logró una precisión predictiva del 86.2% en la clasificación de los efectos de los fármacos, abordando el desafío de las altas tasas de fracaso (más del 90%) en ensayos clínicos que resultan en costos de desarrollo que superan los 2 mil millones de dólares por fármaco. El enfoque innovador combina IA/ML con múltiples ensayos de screening de mini-corazones humanos para mejorar las capacidades de clasificación de fármacos, reduciendo potencialmente los costos y mejorando la seguridad en el desarrollo de medicamentos.
메데라는 자회사인 노보하트가 인공지능 및 머신러닝을 활용하여 인간 미니 심장 기술로 약물 스크리닝을 향상시키고 있음을 보여주는 연구 결과를 약리학 연구에 발표했다고 알렸습니다. 이 연구는 약물 효과를 분류하는 데 있어 86.2%의 예측 정확도를 달성하였으며, 임상 시험에서 90% 이상의 높은 실패율이 발생하여 약물당 개발 비용이 20억 달러를 초과하는 문제를 해결했습니다. 이 혁신적인 접근법은 여러 인간 미니 심장 스크리닝 분석과 함께 AI/ML을 결합하여 약물 분류 능력을 향상시키며, 비용을 줄이고 약물 개발의 안전성을 높이는 데 기여할 수 있습니다.
Medera a annoncé la publication d'une étude dans la Recherche Pharmacologique démontrant comment sa filiale Novoheart utilise l'IA et l'apprentissage automatique pour améliorer le dépistage des médicaments grâce à la technologie de mini-coeurs humains. L'étude a atteint une précision prédictive de 86,2% dans la classification des effets des médicaments, s'attaquant au défi des taux d'échec élevés (plus de 90%) dans les essais cliniques, qui entraînent des coûts de développement dépassant 2 milliards de dollars par médicament. Cette approche innovante combine l'IA/AA avec plusieurs essais de dépistage de mini-coeurs humains pour améliorer les capacités de classification des médicaments, ce qui pourrait réduire les coûts et augmenter la sécurité dans le développement des médicaments.
Medera hat die Veröffentlichung einer Studie in der Pharmakologischen Forschung angekündigt, die zeigt, wie ihre Tochtergesellschaft Novoheart Künstliche Intelligenz und maschinelles Lernen nutzt, um das Screening von Arzneimitteln mit menschlicher Mini-Herz-Technologie zu verbessern. Die Studie erreichte eine prädiktive Genauigkeit von 86,2% bei der Klassifizierung der Arzneimittelwirkungen und geht somit der Herausforderung hoher Misserfolgsquoten (über 90%) in klinischen Studien nach, die Entwicklungskosten von mehr als 2 Milliarden Dollar pro Arzneimittel zur Folge haben. Dieser innovative Ansatz kombiniert KI/ML mit mehreren Screening-Assays für menschliche Mini-Herzen, um die Klassifikationsfähigkeiten von Arzneimitteln zu verbessern, was potenziell die Kosten senken und die Sicherheit in der Arzneimittelentwicklung erhöhen könnte.
- Achieved 86.2% predictive accuracy in drug classification using AI-based algorithm
- Technology could reduce drug development costs from current $2+ billion average
- Innovation aligns with FDA Modernization Act 2.0 requirements
- Technology will be commercially available through Novoheart's platforms
- Current drug development process shows over 90% failure rate in clinical trials
Insights
This publication represents a significant technological advancement in drug screening methodology. The 86.2% predictive accuracy achieved through AI/ML integration with mini-Heart technology is particularly noteworthy, as it could substantially reduce the
The platform's ability to combine multiple cardiac assays with machine learning creates a more comprehensive and accurate drug screening process. This aligns with FDA Modernization Act 2.0 requirements and positions Medera/Novoheart favorably in the preclinical testing market. The commercial availability of this technology through Novoheart's platforms could generate significant recurring revenue streams.
For KVAC shareholders, this technological breakthrough strengthens the merger value proposition, as it demonstrates Medera's innovative capabilities and potential for market leadership in drug development efficiency tools.
- Traditional methods for evaluating therapeutic efficacy and cardiotoxicity often lead to high failure rates during clinical trials, resulting in significant development costs
- Human-specific diseases cannot be accurately modeled by animals, leading to limited medical options or advancements
- This new study leverages the capabilities of artificial intelligence (AI) and machine learning (ML) to address the challenge of achieving automated and comprehensive "smart" drug screening using Medera's mini-Heart technology platform
- Innovative AI/ML-based model combines data from multiple human mini-Heart screening assays and takes advantage of the complementary strengths to achieve superior next-generation drug classification capabilities
- The unique combination of AI/ML and human mini-Hearts can accelerate drug discovery, clinical translation and precision medicine by improving screening efficiency, reducing costs, enhancing safety and creating new opportunities for patient benefits
The present work aims to address a long-standing challenge in the pharmaceutical industry: accurately screening and classifying drug candidates for their effects on human heart function. By applying AI-driven automation, the objective is to enhance the success rates of future clinical trials and ultimately improve patient benefits by modernizing the drug development process.
Traditional methods for evaluating therapeutic efficacy and cardiotoxicity often lead to high failure rates (over
By testing three distinct proprietary engineered human mini-Heart assays, including our flagship human-heart-in-a-jar, specialized for measuring different cardiac characteristics, with a library of known compounds spanning a range of drug classes, the Novoheart research team generated a robust dataset encompassing electrophysiology and contractility parameters. The resulting ensemble AI-based algorithm achieved an impressive
"By harnessing the power of machine learning in our suite of human-based mini-Heart assays, we are advancing the frontiers of preclinical drug development," stated Kevin Costa, Ph.D., Novoheart's Chief Scientific Officer and co-founder. "This innovation simplifies and improves the cardiac screening process for both our internal teams, partners and clients utilizing Novoheart's technology."
"This innovative approach clearly outperforms traditional single-assay models and aligns with the objectives advocated in the FDA Modernization Act 2.0," stated Ronald Li, Ph.D., Medera's CEO and Founder. "The unique combination of AI/ML with human mini-Hearts can significantly accelerate drug discovery and screening, reduce costs, and improve precision by automating the analysis of very complex biological data. It can minimize the need for animal testing and enhance predictive toxicology, reducing the risk of late-stage failures, thereby increasing successes for drug developers and maximizing benefits for patients. Such a human-based AI approach also promotes precision medicine (by taking into consideration different genetic backgrounds or disease mutations) and optimization of formulations, leading to more effective and marketable therapies and improving patient safety throughout the drug development process."
This AI/ML-based automation will be made commercially available via Novoheart's software and hardware platforms. Please direct any inquiries to sales@novoheart.com.
On September 5, 2024, Medera and Keen Vision Acquisition Corporation ("KVAC") (Nasdaq: KVAC, KVACW), announced they had entered into a definitive merger agreement.
About Medera
Medera (www.medera.bio) is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, utilizing next-generation gene and cell-based approaches in combination with bioengineered human-based technology (including the mini-Heart platform). Medera operates via the two preclinical and clinical business units, Novoheart and Sardocor, respectively.
Novoheart capitalizes on the world's first and award-winning "mini-Heart" Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials.
Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart's human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases.
About Keen Vision Acquisition Corporation
Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives. EF Hutton LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are serving as Capital Markets Advisors for KVAC.
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SOURCE Keen Vision Acquisition Corporation; Medera Inc.
FAQ
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