Biomica Announces Interim Positive Results from Pre-Clinical Studies in its Irritable Bowel Syndrome (IBS) Program

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07/19/2023 - 07:00 AM

The results demonstrate the efficacy of Biomica's live bacterial consortia, BMC426 and BMC427, for the treatment of IBS

REHOVOT, Israel, July 19, 2023 /PRNewswire/ -- Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), reported today interim positive results from pre-clinical studies in its IBS program. The pre-clinical work was performed in collaboration with the lab of Prof. Kara Gross Margolis, Associate Director for Clinical and Translational Research for the New York University Pain Research Center and an Associate Professor in the Department of Molecular Pathobiology in the NYU College of Dentistry and the Department of Pediatrics at NYU Grossman School of Medicine. In these studies, Biomica tested two candidate therapeutic consortia of live bacterial strains, BMC426 and BMC427. Treatment with these drug candidates effectively reduced visceral pain, a major symptom of IBS.

Irritable bowel syndrome, or IBS, is a chronic digestive system disorder estimated to affect 4.1% of the worldwide population^[1]. IBS-affected individuals suffer from abdominal pain, bloating, and abnormal bowel movements; that often affect their daily functioning and quality of life. Current standard therapies for IBS are limited, particularly in relation to IBS-associated abdominal pain. Studies have pointed to associations between alterations in the gut microbiome and IBS, suggesting microbiome involvement in developing IBS symptoms^[2].

BMC426 and BMC427 were designed based on their functional capabilities, utilizing data collected from IBS patients through research conducted at the University of North Carolina (UNC) Chapel Hill by Prof. Yehuda Ringel, Co-Founder and Chief Scientific Officer of Biomica. The data was analyzed in silico using Biomica's PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. Numerous functional capabilities of BMC426 and BMC427 have been successfully validated in relevant in-vitro models.

Today, Biomica is announcing positive results observed in its in-vivo pre-clinical work, which aimed to evaluate the potential of BMC426 and BMC427 in treating IBS. The results revealed that animals treated with either BMC426 or BMC427 displayed significantly lower levels of visceral sensitivity compared to the placebo-treated group. The study design and initial results will be presented in an oral presentation at the NeuroGASTRO conference of the European Society of Neurogastroenterology and Motility (ESNM) in September 2023.

These results lay the foundation for Biomica's advancement of its IBS therapeutics development program. In the coming year, Biomica plans to explore additional parameters related to pain reduction and the alleviation of other IBS symptoms, building upon these promising pre-clinical findings.

Prof. Kara Gross Margolis said: "The results of this study are incredibly exciting as they are the first to show that BMC426 or BMC427 may be helpful in the treatment of visceral pain in IBS and other gastrointestinal disorders, that are highly common with few effective therapies."

"We express our sincere gratitude to Prof. Kara Gross Margolis and her team at NYU, as their involvement has been instrumental in the promising results achieved in these in-vivo pre-clinical studies," said Prof. Yehuda Ringel. "By leveraging our innovative computational approach, which harnesses big data and high-resolution microbiome analysis to identify the optimal microbes for our product, we are poised to introduce a promising, microbiome-targeted therapy for this chronic and debilitating condition. We eagerly look forward to sharing further updates on the progress of this program as we continue our journey forward."

^[1] https://pubmed.ncbi.nlm.nih.gov/32294476/^[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039952/

About Biomica's IBS therapeutic candidates: BMC426 and BMC427

BMC426 and BMC427, which are Live Bacterial Products (LBPs), are rationally designed consortia designed to restore specific functionality to a microbial community with individually selected, cultured bacteria. BMC426 and BMC427 are comprised of bacterial strains selected for their multiple desired functions to achieve maximal functional activity with only 4 or 5 bacterial strains, respectively. These LBP's are aimed to result in robust metabolic and immune modulation, and affect IBS through several underlying and complementary modes of action.

About PRISM:

PRISM enables high-resolution microbiome computational analysis with specific emphasis on the functional aspects of the microbiome, host-microbe and microbe-microbe interactions, supporting a mechanistic approach to strains selection and providing the basis for Biomica's rational design of therapeutic live bacterial consortia.

About Biomica Ltd.:

Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN).

For more information, please visit www.biomicamed.com.

About Evogene Ltd.:

Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost. Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI, and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI).

Evogene uses its tech-engines to develop products through subsidiaries and strategic partnerships. Evogene's subsidiaries currently utilize the tech-engines to develop human microbiome-based therapeutics by Biomica, ag-biologicals by Lavie Bio, ag-chemicals by AgPlenus, medical cannabis products by Canonic and castor varieties, for the biofuel and other industries, by Casterra.

For more information, please visit www.evogene.com.

Forward-Looking Statements:

This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "will", "may", "could", "expects", "intends", "anticipates", "plans", "believes", "scheduled", "estimates", "demonstrates", or words of similar meaning. For example, Evogene and Biomica are using forward-looking statements in this press release when they discuss Biomica's products potential to bring a new form of therapy for chronic and devastating condition, the drug candidates' ability to reduce visceral pain in IBS and other gastrointestinal disorders, and the progress of the pre-clinical trials. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, and involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, those risk factors contained in Evogene's reports filed with applicable securities authorities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections, and assumptions.

Contacts
Rachel Pomerantz Gerber
Head of Investor Relations at Evogene
rachel.pomerantz@evogene.com
Tel: +972-8-9311901

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