The Biosys Health group of companies (Biosys Health) is developing oral immune therapies that target and modulate the gut microbiome for gastrointestinal, brain, and metabolic disorders.
The gut microbiome is involved in intestinal immune responses during health and disease, and IgA antibodies play a critical role in the defense against pathogens and maintenance of intestinal homeostasis. Biosys Health is harnessing the power of oral polyclonal IgA therapies to modulate gut microbiota composition and restore host–microbial symbiosis.
Antibody platform : 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 polyclonal antibody platform is robust and can be tailored to generate antibodies against any target antigen to modulate the gut microbiome.
Products: The Centers for Disease Control and Prevention (CDC) has declared C.difficile infection (CDI) 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 use of broad‑spectrum antibiotics is associated with an increased incidence of CDI. Antibiotic-mediated disruption of gut microbiota depletes primary bile acid converters, which enables C. difficile sporulation and growth. Antibiotics also deplete competing sialic acid and succinate consumers, liberating an energy source for C. difficile. Biosys Health’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.