Ward Peterson joined Symberix in late 2013 after realizing that the company had potential to make unprecedented strides in the field of biopharmaceuticals.
Symberix, based in Durham, is a preclinical stage company working toward the development of original pharmaceutical treatments for lower gastrointestinal disorders. Still in its early stages, the company hopes to pioneer the discovery of a new class of drugs designed to safely and selectively target the microbiome.
The company’s website explains the significance involving targeting bacteria in the microbiome.
“The microbiome contributes fundamentally to both human health and illness. Until now the only way to control a disease-causing component of microbiome activity is with antibiotics, but antibiotics also harm the beneficial bacteria essential for human health.” the site says. “We plan to discover and develop what may be the first examples of bacteria-targeted drugs that are not antibiotics.”
Symberix is co-founded by Peterson, a pharmaceutical scientist, and Matthew Redinbo, a professor at UNC-Chapel Hill and former chair of the university’s chemistry department. Through the Office of Technology Commercialization, Peterson connected with principal investigators that had technology ready to be advanced. A microbiome-focused company caught his attention. That company later became Symberix.
Peterson and Redinbo met through UNC Kickstart Ventures in 2010, where Peterson was sent documents that disclosed the overall technology. Sparking his interest, Peterson joined Redinbo in co-founding Symberix.
Grants help company’s kickstart
Initially, both Peterson and Redinbo worked pro bono. The company had no staff members besides its two founders. In order for the business to take the next step, they decided to finance the company through government grants, particularly through the Small Business Innovation Research program, or SBIR, for the purpose of focusing on research and development.
SBIR was the ideal program to help fund Symberix because it encourages domestic small businesses to engage in research and development that has the potential for commercialization. Symberix has been awarded eight SBIR grants, which has gone primarily toward hiring Symberix’s staff of five scientists.
Additionally, the company has raised about $2 million to date, with the majority of going to salaries for the staff of scientists along with lab supplies and agents to run experiments. Property costs were not an issue for the company; Symberix took part in a facility user agreement with UNC-CH, allowing the company’s staff to take shop in the university’s labs for nearly three years.
About a year and a half ago, Symberix relocated to BioLabs in Durham.
Peterson explained that Symberix is far from a finished product, and because it is developing something is first in its class, there’s no model for running a business such as Symberix.
“The company is very early stage — there’s no precedence for what we’re doing,” Peterson said. “There’s not even a word to describe drugs that control bacteria but don’t kill them, and so we don’t call any of our drugs symbiotic drugs.”
The product, which would be branded, would prevent serious side effects of certain pain and cancer medications in the lower gastrointestinal tract such as diarrhea, anemia and intestinal bleeding caused by a bacterial enzyme in the microbiome.
The process of reaching a branded product is a long one, however.
The road to FDA approval
Ultimately, the drug will have to go through U.S. Food and Drug Administration approval. Before that, Symberix will have to file an investigational new drug (IND) application, partake in clinical and preclinical studies, file a chemistry, manufacturing and controls (CMC) application so the product can be manufactured, and then file a new drug application.
Typically, the average time it takes to go from preclinical stages to FDA approval is around 11 to 13 years.
Filing applications and clinical studies are certainly an obstacle in Symberix’s path to pioneering a drug that surpasses the effectiveness of antibiotics.
“What makes it difficult is that we have a rudimentary understanding of what it means to drug the microbiome,” Peterson said. “Basically all FDA approved drugs can be classified in one of two camps. One is targeting human genomes, the other is killing pathogens like antibiotics.”
When asked the biggest obstacle, Peterson explained that it’s the unprecedented nature of their start-up and its scientific complexities.
“There’s no example of something where you target bacteria but don’t kill it,” he said. The biggest obstacles are “lack of precedent and the enormous complexities of the microbiome. There’s about 20 to 30,000 genes in the human genome; the human microbiome has over 8 million genes.”
Seeing as this is a time-consuming process, Peterson has gradually increased the amount of time he spends on Symberix. While Redinbo works full-time as a professor at UNC-CH, Peterson now works nearly full-time on Symberix.
He began spending 25 percent of his work hours at Symberix, before raising that amount to 50 percent, then 75 percent, and now Peterson says he works on the company about 80 to 90 percent of the time. Redinbo, on the other hand, mainly does consulting for Symberix.
In the near future, however, Peterson, Redinbo and the employees of Symberix are focused on identifying a clinical candidate and filing an IND application, which would give them authorization to begin their first phase of clinical trials.
It takes about a year between the time of identifying the candidate and the filing IND application. From there, Peterson says it will be about five years until the company files a new drug application, which is followed by waiting for the FDA’s review and approval of the product.
The process is timely, but upon its completion, Symberix would provide a revolutionary biopharmaceutical drug capable of making antibiotics a thing of the past.
