gastrointestinal colic

BASEL, Switzerland I October 23, 2024 I AMYRA Biotech AG (“AMYRA”), 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 ( https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1425982/full ). 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. In the human gastrointestinal tract, most exopeptidases are found at the intestinal brush border membrane, which is sensitive to inflammatory damage. These exopeptidases are essential for completing protein digestion by cleaving peptides from end-to-end, generating absorbable amino acids. He added: “As single agents, exopeptidases are inefficient as they have limited substrate range, and we see this with DPP-IV supplements currently on the market. AMYRA specializes in developing unique combinations of exopeptidases with complementary and enhanced activity, designed to thoroughly break down proteolytically resistant food peptides. Ultimately, complex digestive diseases such as celiac may require a combination of treatment approaches. Given the critical role of the exopeptidase machinery in the human GI tract, and the vulnerability of the intestinal brush border membrane to chronic inflammatory damage, we’re excited to see the role that AMYNOPEP will play in digestive disease therapeutics.” “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.” About AMYRA Biotech AG AMYRA Biotech AG is a privately held biotech company developing novel therapeutic solutions for patients suffering from dietary peptide-driven disorders including celiac disease, gluten sensitivity, and other gastrointestinal disorders. The Company’s proprietary enzyme combinations have the unique capability of rapidly and systematically digesting proteolytically resistant gluten peptides from one end to the other, generating harmless and absorbable degradation products in the small intestine.  AMYRA is based in Basel, Switzerland. For further information, please visit www.amyra.com. About AMYNOPEP Several digestive enzyme supplements on the market and therapeutics under development seek to help the body break down hard-to-digest gluten peptides, which are known to trigger adverse reactions in individuals with gluten-related health disorders. The vast majority of these are endopeptidases that target gluten digestion in the stomach and generate smaller protein fragments (peptides) that may retain the ability to trigger an inflammatory response. In contrast, AMYNOPEP is a novel therapeutic enzyme principle based on specific combinations of exopeptidases that thoroughly degrade gluten peptides from end-to-end in the small intestine, generating individual, easily absorbable, and harmless amino acids and dipeptides that are incapable of triggering an immune response. AMYRA’s lead exopeptidase combination, AMYNOPEP, is capable of digesting proline-rich, hard-to-digest peptides found in foods such as gluten, which is notoriously linked to gastrointestinal distress. SOURCE: AMYRA Biotech

Researchers have identified a mechanism that causes severe gastrointestinal problems with immune-based cancer treatment, also finding a way to deliver immunotherapy's cancer-killing impact without the unwelcome side effect. Researchers at the University of Michigan Health Rogel Cancer Center have identified a mechanism that causes severe gastrointestinal problems with immune-based cancer treatment. They also found a way to deliver immunotherapy's cancer-killing impact without the unwelcome side effect. The findings are published in Science. "This is a good example of how understanding a mechanism helps you to develop an alternative therapy that's more beneficial. Once we identified the mechanism causing the colitis, we could then develop ways to overcome this problem and prevent colitis while preserving the anti-tumor effect," said senior study author Gabriel Nunez, M.D., Paul de Kruif Professor of Pathology at Michigan Medicine. Immunotherapy has emerged as a promising treatment for several types of cancer. But immune checkpoint inhibitors can also cause severe side effects, including colitis, which is inflammation in the digestive tract. Colitis can cause severe gastrointestinal discomfort, and some patients will discontinue their cancer treatment because of it. The problem facing researchers was that while patients were developing colitis, the laboratory mice were not. So researchers couldn't study what was causing this side effect. To get past this, the Rogel team, led by first author Bernard C. Lo, Ph.D., created a new mouse model, injecting microbiota from wild-caught mice into the traditional mouse model. In this model, the mice did develop colitis after administration of antibodies used for tumor immunotherapy. Now, researchers could trace back the mechanism to see what was causing this reaction. In fact, colitis developed because of the composition of the gut microbiota, which caused immune T cells to be hyper-activated while regulatory T cells that put the brakes on T cell activation were deleted in the gut. This was happening within a specific domain of the immune checkpoint antibodies. Researchers then removed that domain, which they found still resulted in a strong anti-tumor response but without inducing colitis. "Previously, there were some data that suggested the presence of certain bacteria correlated with response to therapy. But it was not proven that microbiota were critical to develop colitis. This work for the first time shows that microbiota are essential to develop colitis from immune checkpoint inhibition," Nunez said. To follow up what they saw in mice, researchers reanalyzed previously reported data from studies of human cells from patients treated with immune checkpoint antibodies, which reinforced the role of regulatory T cells in inducing colitis. The antibody they used to stop the colitis was developed by Takeda Pharmaceuticals. The Rogel team plans additional studies to further understand the mechanisms causing colitis and seeks clinical partners to move this knowledge to a clinical trial. Additional authors are Ilona Kryczek, Jiali Yu, Linda Vatan, Roberta Caruso, Masanori Matsumoto, Yosuke Sato, Michael H. Shaw, Naohiro Inohara, Yuying Xie, Yu Leo Lei and Weiping Zou. Funding for this work is from National Institutes of Health grants R01 DK121504, R01 DK095782, R01 DE026728, R01 DE030691, P30 CA046592; Takeda Millennium Pharmaceuticals, Canadian Institutes of Health, Crohn's and Colitis Foundation, National Science Foundation grant IOS-2107215. This work was supported by these Rogel Cancer Center Shared Resources: Single Cell Spatial Analysis, Tissue and Molecular Pathology

CHINO, Calif., Dec. 5, 2023 /PRNewswire/ -- A study published in the Global Journal of Microbiology and Biotechnology finds adding the probiotic, Bacillus coagulans LBSC (SEB LBSC), to food products offers promising health benefits while maintaining the food's appearance, aroma, taste and texture. The objective of the study, titled "Stability of Bacillus coagulans LBSC and Effect on Sensory Attributes in Tortillas, Tortilla Chips, and Chocolate," was to determine the stability of Bacillus coagulans LBSC in tortillas, tortilla chips and chocolate with ganache, as well as evaluating its impact on sensory attributes when compared to control products (with no probiotic added). "The findings of this research point to a significant opportunity for food manufacturers," said Vic Rathi, President of Enzyme Innovation. "They can add consumer-desired ingredients, offering real health benefits, without negatively impacting the quality of the finished product or their bottom line." Known for being heat-stable and spore-forming, Bacillus coagulans LBSC demonstrated robust stability when added to the tested food products, with a survival rate ranging from 42 to 98% (depending on the food). Results showed the test food items were rated similar in quality parameters such as aroma, taste, texture, acceptability and likeability when compared to their corresponding controls, indicating this probiotic seamlessly integrates into foods without altering their sensory appeal. Bacillus coagulans LBSC was added using conventional processes without the need for specialized equipment, making it a cost-effective option for various food items and promoting widespread accessibility. Published clinical trials on Bacillus coagulans LBSC found it offers significant gut and immune health benefits, including help recovering from digestive discomfort, and supporting microflora balance and regularity. The full research paper, authored by Sophia Leung, Malissa Keo, Amber Montes, Angel Go, Dr. Assad Al-Ammar, Dipak Roda, and Vic Rathi, can be found in Volume 11, Number 1 (2023) of the Global Journal of Microbiology and Biotechnology. Visit EnzymeInnovation.com/baking-milling/probiotics/ for more information, and contact the company to add it to your product line! About Enzyme Innovation Enzyme Innovation is a research-driven manufacturer with 60 years of manufacturing experience and unparalleled expertise in industrial probiotics and enzymes. The company provides clean-label, eco-safe solutions to more than 25 industries, including baking and milling, craft and brewing, animal nutrition and protein hydrolysis. Products are produced in Enzyme Innovation's state-of-the-art, GMP-certified manufacturing facilities, which boast a long list of elite accreditations, including NSF GMP, FSSC 22000, GFSI, NSF Gluten-Free, ISA Halal, OK Kosher and The Non-GMO Project. Products are tested in a full-service ISO-17025 certified laboratory. SOURCE Enzyme Innovation