Our focus turns to biofilms and with the expertise of Scioto Biosciences, a preclinical stage company devoted to having a transformative impact on the delivery of microbiome therapeutics; we discuss their role, characteristics and future potential in developing novel therapeutics.
Scioto describe biofilms as communities of bacteria covered by a self-forming matrix. They explain that bacteria in a biofilm are better able to survive stress from the environment including immune clearance as well as antimicrobial compounds:
Bacteria in the human microbiome are often in a biofilm state, including healthy commensally bacteria that reside in the mucosal barrier, which makes improving the microbiome with beneficial probiotic bacteria difficult.
The Scioto Platform offers a novel formulation that primes the colony-forming mechanisms of probiotic bacteria by combining beneficial bacteria with polysaccharide microspheres. These natural mechanisms induce ‘biofilm’ formation, enhance probiotic function and allow for non-spore forming bacteria to survive passage through the gastrointestinal system, potentially enhancing efficacy when probiotics are used, making them better suited to colonize and provide lasting beneficial effects.
We caught up with Steve Goodman, Ph.D. and Gail Besner, M.D., two of Scioto’s scientific founders for an exclusive interview. Joe Trebley, CEO of Scioto, also contributed to this interview.
MT: What are the discoveries that lead up to your current work?
SB: We have researched for many years bacterial pathogens that cause periodontal disease. It was critical that these bacteria form a biofilm in order to colonize and persist as a pathogen in those disease states. Our key insight was that live bacterial therapeutics also form biofilms. It was our hypothesis that formulating live bacteria in biofilm form would lead to better, persistent bacterial therapeutics. In that case, we could apply everything we had learned about biofilm formation to come up with superior formulations of live bacterial therapeutics. We then set out with Mike Bailey, Ph.D. and Lauren Bakaletz, Ph.D., the two other Scioto scientific founders, to evaluate the hypothesis in some key proof-of-concept studies.
MT: How accurate is your data & how sure are you of your conclusions?
SB: Our data have been reproduced on many hundreds of prematurely delivered rat pups, across multiple different lab members, providing confidence in the data.
MT: How did you feel when you first understood the positive outcome of your research?
SB: Nationwide Children’s Hospital (NCH) in Columbus, OH, provides the first data demonstrating the value of the platform. The data came in the form of a successful animal study in a well-characterized gut injury model for necrotizing enterocolitis (NEC). Over the past 2 1/2 decades our Scientific founder Dr Gail Besner, Chief of Pediatric Surgery at NCH, performed basic science research on necrotizing enterocolitis. Her lab has done intensive investigations of growth factors, stem cells, and stem cell-derived microvesicles in the protection of the intestines from NEC.
Dr. Besner affirmed that ‘’the live bacterial therapeutic platform delivery system provided the best protection against NEC that I have seen in all of my years doing this type of research. In addition, the components are well-characterized and readily available, and the therapy is much more likely to be safe. When I first saw the positive results we were getting I could hardly believe it. Now I am really excited to bring this cutting-edge therapy to the bedside.”
MT: What got others interested in your findings?
SB: This proof-of-concept data caught the attention of a Midwest Venture Accelerator called Monon Bioventures. Through the technology transfer office at NCH, Monon Bioventures, were introduced to the scientific founders. The talent of the research team and the remarkably convincing data motivated both sides to seek additional support from the National Institutes of Health through their small business technology transfer (STTR) granting mechanism. We were awarded $330,000 in a Phase I STTR and an additional $50,000 in a grant from the State of Indiana. Using those funds the team was able to further validate the technology and to demonstrate manufacturability. With those data in hand, we went out to seek investment.
MT: What is needed to turn your findings into a true benefit to your company?
SB: These funds will take us through to an investigational new drug application with the FDA.
MT: What do you expect to be the future implications of applying your findings?
SB: Many, if not most, bacteria have some ability to form a biofilm. Therefore, this platform technology could potentially improve the colonization and persistence of many potential live bacterial therapeutics. There are several companies pursuing ‘bugs as drugs’ for a number of indications including diabetes, metabolic disease, neurological disorders and cancer among many others. We like to say that we make ‘bugs as better drugs’. Our platform could play a significant role in enhancing the pipelines of our colleagues in this space. We are also pursuing our own pipeline developing preventative approaches to limit complications arising from antibiotic use in the elderly and in paediatrics. We are also looking to apply our therapeutics to limit complications like cachexia resulting from cancer, chemotherapy and radiation. In addition to those human health applications, we are also pursuing a significant interest in developing the platform for use in animal health, both in livestock and companion animals.
MT: And there is always the question of; will it be of Rx or of Food Supplement status?
SB: We are developing live bacterial therapeutics and plan to seek approval for use from the appropriate regulatory bodies like the Food and Drug Administration and the European Medicines Agency.
Scioto believe that by enabling colonization in the gut their novel technology will revolutionize probiotic interventions for other pathological states where there is erosion of the mucosal barrier. Erosion of the physical mucus barrier leads to breaches and penetration of toxins, proteins and microbiota to enterocytes of the intestine. The result is collectively termed “leaky gut” and often associated with low levels of chronic GI and systemic inflammation. Thus, Scioto suggest that their technology will serve several unmet medical needs when applied as an intervention to fortify the mucosal barrier in states where breaches are documented.
We thank Dr. Goodman, Joe Trebley and Dr. Besner for their time and contribution and also LaVoieHealthScience.
For more information, contact Scioto Biosciences on: http://sciotobiosciences.com