London, UK (10 February 2017) – Biosys UK Limited (“Biosys” or the “Company”), a clinical-stage microbiome company dedicated to the development of targeted oral immune therapies that modulate the gut microbiome, initially focused on the treatment of C.difficile infection (“CDI”), is pleased to announce that Axel Wiest, M.D., Ph.D., M.P.H., has joined the board of the Company.
The Centers for Disease Control and Prevention (“CDC”) has declared C.difficile one of three urgent public health threats as it causes life-threatening diarrhea. In 2011, there were almost half a million infections in the US alone and 29,000 CDI-associated deaths within 30 days of initial diagnosis. It has been report that CDI 30-day mortality rates are as high as 14% in some countries. C. difficile has become the most common microbial cause of healthcare-associated infections in US hospitals and results in up to $6.3 billion in excess health care costs annually. The Biosys group of companies (the “Group”) is harnessing the power of oral polyclonal IgA therapies to modulate gut microbiota composition and restore host–microbial symbiosis to treat CDI. Oral polyclonal antibodies have specificity for multiple epitopes and can be delivered directly to the site of infection or dysbiosys in the intestine. The secretory component of sIgA protects it from digestion which provides an advantage over IgG antibodies. The initial focus is on CDI where the Group’s oral polyclonal antibodies target both the C.difficile spores and bacteria that cause relapse and recurrence of infection, as well as the C.difficile toxins that cause clinical symptoms and disease pathologies. This is a targeted approach that eliminates specific pathogens and reduces the recolonization of C.difficile across multiple strains. Clinical data in over 100 patients has been published and shows evidence of both efficacy and safety in reducing relapse of C.difficile associated diarrhea. The polyclonal antibody platform is robust and can be tailored to generate antibodies against any target antigen to modulate the gut microbiome.
“As we progress toward the initiation of our pivotal clinical trial for the treatment of CDI, we continue to strengthen our board with experts from the biopharmaceutical industry,” said Dr. Gunnar Weikert, Chairman of Biosys. “Dr. Wiest has breadth of knowledge and years of experience across R&D, biopharma manufacturing, clinical development, regulatory approval, and marketing and sales. We are excited to welcome him to the team.”
Dr. Wiest is a senior executive with several years of experience in the biopharmaceutical and healthcare industries. He is SVP/COO R&D and Head of Global Strategy and Business Operations R&D at Merck Biopharma. Previously, he was VP for Strategy and Project Management at Boehringer Ingelheim Biopharmaceuticals (“BI”), BI’s division for Contract Manufacturing, NBE and Biosimilar process development and manufacturing. He was also COO at Fresenius Biotech GmbH and President of Fresenius Biotech North America Inc. based in Munich and Waltham, MA, respectively, focused on the development and commercialization of biopharmaceuticals in the areas of oncology, transplantation and immunology. Previously, he served as a management consultant at A.T. Kearney based in Munich and as a physician in a variety of international settings, such as Colombia, South Africa, and France. He holds an M.D./Ph.D. from the University of Heidelberg and the German Cancer Research Center, as well as a Master of Public Health from the John Hopkins School of Public Health. He is a member of several academic and non-academic advisory boards.
“Joining Biosys at such an exciting time for the Company is an honour,” said Dr. Wiest. “The positive clinical data, innovative science, platform approach and solid development plan are the right mix to tackle the ongoing suffering and death caused by CDI. I look forward to contributing my experience to the next stage of clinical development.”
The Biosys group of companies (the “Group”) is dedicated to the clinical-stage development of targeted oral immune therapies that modulate the gut microbiome for gastrointestinal, brain, and metabolic disorders. The initial focus is on the treatment of C.difficile infection where the Group’s oral polyclonal antibodies target both the C.difficile spores and bacteria that cause relapse and recurrence of infection, as well as the C.difficile toxins that cause clinical symptoms and disease pathologies. This is a targeted approach that eliminates specific pathogens and reduces the recolonization of C.difficile across multiple strains. Clinical data in over 100 patients has been published and shows evidence of both efficacy and safety in reducing relapse of C.difficile associated diarrhoea. The Group has a second mucosal healing program that is developing proprietary chitin microparticle products to modulate the immune response, enhance gut health and assist patients with Inflammatory Bowel Disease (“IBD”). Chitin microparticles are ideal for managing IBD as they both modify the immune response and provide a physical barrier effect by binding to gut receptors. This dual mechanism of action promotes mucosal healing while reducing the inflammatory response.