AlveoliX and AMYRA report breakthroughs

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31.10.2024
Alveolix Lung on a Chip system

A new study demonstrates how AlveoliX’ Lung-on-Chip model offers a more accurate and predictive approach to investigating respiratory diseases and testing potential treatments. AMYRA successfully demonstrates a new therapeutic paradigm for Gluten-Related Disorders in a first-in-human study.

AlveoliX, in collaboration with Vitrocell Systems, the University of Bern, and the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) announced the publication of a landmark study in Bioengineering & Translational Medicine. The study, titled “A stretchable human lung-on-chip model of alveolar inflammation for evaluating anti-inflammatory drug response”, was made possible through the AIM-4-Doc grant from Eurostars.

Key Findings of the Study

AlveoliX’s Lung-on-Chip model accurately mimics the human alveoli’s microenvironment, simulating breathing dynamics and disease conditions. Such cutting-edge technology enables high-fidelity disease modeling, drug screening, and toxicity testing, empowering researchers to explore therapies for complex lung diseases such as chronic obstructive pulmonary disease (COPD), asthma, pulmonary fibrosis and acute respiratory distress syndrome (ARDS).

One of the standout features of this system is the integration of patient-derived cells, enabling personalized treatment strategies tailored to individual responses. The Lung-on-Chip model not only bridges the gap between preclinical and clinical outcomes but also reduces reliance on animal testing, aligning with the 3R principle (Replace, Reduce, Refine).

This study is the result of a strong collaboration between two industry entities, AlveoliX and Vitrocell Systems, and two academic partners, the University of Bern and the University of Saarland. The Eurostars AIM-4-Doc project brought together expertise from industry and academia to push the boundaries of Lung-on-chip technology. Through this collaboration, the Alexis Technologies spin-off was later initiated, further driving innovation in the field by providing these unique systems that combine inhalation exposure systems with breathing Organs-on-Chip technology, opening up broad applications in toxicological assessment of new chemicals, pesticides, cosmetic safety evaluations, and environmental pollutant studies.

AMYRA’s lead product achieves proof of principle

AMYRA Biotech, a company developing novel, oral digestive enzyme therapeutics for gastrointestinal diseases announced the peer-reviewed publication of its clinical proof-of-principle study with its lead product AMYNOPEP in Frontiers in Immunology - Nutritional Immunology. AMYNOPEP is the first and only gluten-digesting enzyme combination that supports and enhances the activity of critical endogenous enzymes on the lining of the small intestine. AMYNOPEP is designed to break down hard-to-digest gluten peptides into harmless and absorbable single amino acids and dipeptides, thereby supporting individuals with gluten-related health disorders in avoiding exposure to inflammatory peptides. AMYRA’s first-in-human clinical study assessed gluten-digesting enzyme efficacy using high-resolution analytics and demonstrated in near-real-time that AMYNOPEP swiftly and significantly enhanced the digestion of proteolytically-resistant, immunogenic gluten peptides in healthy volunteers.

A team of researchers from AMYRA and the University of Greifswald (Germany) evaluated AMYNOPEP’s digestive efficacy on the degradation of a long, proteolytically resistant gluten peptide known as the 33-mer, which has been associated with an adverse immune response in celiac disease. The digestion efficacy of AMYNOPEP on the 33-mer was first assessed in vitro, demonstrating end-to-end degradation of the gluten immunogenic peptide into single amino acids and dipeptides. These in vitro results were then validated in a crossover study of 14 healthy volunteers who received stable isotope-labelled 33-mer with and without AMYNOPEP. The study clearly showed that AMYNOPEP enhanced 33-mer digestion kinetics within minutes, significantly increasing levels of stable isotope-labelled amino acids detected in blood. Strikingly, AMYNOPEP improved 33-mer digestion even under “stress-test” conditions that included competing food substrates such as hydrolyzed whey protein and wheat gluten, revealing up to 3 times higher maximum concentrations of labelled amino acids in blood with AMYNOPEP compared to control.

“The positive results of this proof-of-principle study pave the way for a new therapeutic enzyme paradigm leveraging specific exopeptidase combinations that support, enhance, or even replace the activity of critical endogenous enzymes lining the small intestine,” said Dr. Sulay Mourabit, CSO of AMYRA and co-lead author on the study.

“This is an encouraging and far-reaching proof-of-principle study demonstrating the validity and therapeutic relevance of our approach,” said Dr. Werner Tschollar, CEO and founder of AMYRA and senior author of the study. “As a next step, AMYRA is planning further clinical studies to investigate AMYNOPEP’s enzyme efficacy, immune response suppression, and symptom relief in patients with celiac disease. We strongly believe that supplementing the body with specific exopeptidases will prove to be a valuable adjunct therapy to the gluten-free diet, which alone represents a suboptimal solution.”

(Press release / SK)
Picture: AlveoliX’ Lung-on-Chip model

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