Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) and (TASE: EVGN), announces the initiation of pre-clinical studies for BMC321 & BMC322, two rationally-designed microbial consortia aimed to reduce inflammation for the treatment of Inflammatory Bowel Disease (IBD).
Biomica’s program aims to develop a novel microbiome-based drug for IBD that triggers multiple mechanisms for the reduction of intestinal inflammation. This is the second program Biomica has advanced to pre-clinical studies, following the initiation of preclinical studies in its oncology program.
IBD including ulcerative colitis and Crohn’s disease are chronic, debilitating, non-infectious, inflammatory diseases of the digestive tract. The incidence of IBD is increasing and the overall response to current available treatments is limited to 40-60%.
The role of the microbiome in IBD etiology is well established and it is now recognized as an important target for development of new treatments for these diseases. Led by Prof. Yehuda Ringel (CSO) Biomica’s IBD drug development program has taken a unique scientific approach targeting multiple microbial-related mechanisms that underlay the intestinal inflammation of IBD. The discovery process implements PRISM, a proprietary high-resolution computational microbiome analysis platform based on Evogene’s CPB platform. PRISM is designed to process big data, enabling the identification of microbial functions and strains. Biomica’s computational approach allows for a thorough understanding of the functional elements of the microbiome that are relevant to the human condition and enables a rational design of live bacterial consortia based on the smallest number of strains bearing multiple desired activities. The approach is expected to yield maximal therapeutic effects while minimizing the potential for adverse effects.
Biomica’s IBD discovery campaign involved implementing a large comparative analysis of hundreds of stool samples obtained from IBD patients. This analysis resulted in the detection of an array of microbial functions associated with states of inflammation and remission as well as in the identification of specific bacterial strains carrying these functions. These strains and functions have been combined to design Biomica’s consortia BMC321 & BMC322. The tolerability and efficacy of BMC321 & BMC322 are currently being evaluated in pre-clinical studies using multiple IBD animal models.
In addition to the advancement of the IBD program, Biomica is pleased to welcome Prof. David T. Rubin, a renowned gastroenterologist who specializes in the research and treatment of IBD as a scientific and medical advisor. Prof. Rubin is Section Chief, Gastroenterology, Hepatology and Nutrition and a Co-Director of the Digestive Diseases Center at the University of Chicago. Prof. Rubin is the Chair-elect of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. In addition to numerous awards and honors, Prof. Rubin is the editor of a best-selling book on IBD, and an author or coauthor of many peer-reviewed articles on treatment and management of IBD, cancer in IBD. His current research includes a variety of collaborative studies related to the microbiome and intestinal disease, for more information please see @IBDMD on Twitter. Prof. Rubin joins Prof. Y. Ringel, Prof. B. Sartor, Prof. J. Versalovic and Prof. W. De-Vos in supporting the company’s upcoming steps towards its pre-clinical and clinical development processes.
Dr. Elran Haber, Biomica CEO, stated:
“We are very pleased our second program has advanced from the computational stage to pre-clinical studies. We believe our drug candidate consortia designed to target the underlying causes of inflammation associated with Inflammatory Bowel Disease will provide a new form of therapy for this chronic and devastating condition. Our advancement to pre-clinical trials is based on the outcomes of unique computational insights provided by Biomica’s PRISM platform. We look forward to sharing initial results in 2020. Additionally, I would like to welcome Prof. Rubin. We look forward to working together and expect his vast experience in this field will significantly contribute to this program.”
Prof. R. Balfour Sartor, Biomica Scientific Board member, stated:
“It has been well established that the intestinal microbiome and the diminished microbial diversity are implicated in the pathogenesis of IBD. I believe that Biomica’s novel approach, targeting microbial functions that impact a combination of pathways to reduce inflammation, have the potential to make a true impact on the treatment of IBD patients.”
About BMC321 & BMC322
Developed as Live Bacterial Products (LBPs), BMC321 & BMC322 are rationally-designed LBP consortia comprised of unique microbes that harbor multiple functional capabilities with the potential to reduce gut mucosal inflammation.
Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a microbial community with individually selected, cultured bacteria.