by Nicholas McKeehan
[Originally published on April 16, 2015]
Last February, Symbiotic Health won “Best in Show” at Mid Atlantic Bio Angels’ 1st Pitch Life Science. The company is developing a capsule that uses bacteriotherapy to treat microbiome diseases such as Clostridium difficile (Cdiff). Symbiotic’s story is compelling, especially for such an early-stage venture with a first time CEO, and, in fact, MABA co-founder and 1st Pitch panelist, Steve Goodman said in a press release, “Dr. Honig’s (Symbiotic co-founder and CEO) pitch and responses to questions demonstrated both mastery of the competitive space and a willingness to address challenges to his analysis calmly and directly. His style, as well as his substance, exemplified the maxim that it’s not just the business plan but the management that ultimately brings a company success.” We spoke with Symbiotic CEO Dr. Honig, to find out more about how he has taken a nascent idea brought up in conversation and created a substantial company preparing to test a product in the clinic.
Gerard Honig went to graduate school at the University of California, San Francisco, where he studied the chemical effects of psychiatric drugs on levels of neurotransmitters in the brain. During post-doctoral training at NYU and the Feinstein Institute, he shifted his focus to immunology and microbiology, and began work at the Feinstein Institute looking at the relationship between bacterial infection and blood supply to the brain. As his post-doc at the Feinstein Institute came to an end, Dr. Honig began work on a side project that would eventually become Symbiotic Health.
Dr. Honig’s wife introduced him to Dr. Bruce Hirsch, MD, an infectious disease expert at Northshore LIJ Health System, and the two began to discuss the relationship between bacteria and infectious disease. Deaths from infections such as C. difficile (Cdiff) have increased 400% since 2000, and over 20% of patients do not respond to standard treatment. One prospective treatment, fecal matter transplant, has been shown to be particularly effective against CDiff infections. However, the invasive nature of the treatment limits its use. A few scientists, however – one of whom was Dr. Hirsch – had been playing around with the idea of delivering bacteria to the gut via an oral capsule. Drs. Honig and Hirsch’s conversations soon evolved from broad theoretical ideas to how to overcome specific technical challenges. Namely, how do you get an oral capsule through the stomach and into the intestines where it can deliver live bacteria?
In 2013, the NYCEDC announced the opening of a life science incubator, Harlem Biospace. The opening of the incubator and the positive reception Drs. Honig and Hirsch’s application received became an impetus for the formation of Symbiotic Health. In November, Symbiotic Health became one of the founding companies of Harlem Biospace.
Dr. Honig immediately began to build out his team. He brought on board Dr. Hirsch and two researchers he had previously trained with. Dr. Honig met another member of his team, Dr. Steve Popielarski, while taking part in ElabNYC, an NYCEDC initiative designed to teach bioentrepreneurs business skills and help develop networks.
“The single person I have learned the most from about running a business is Steve Popielarski,” Dr. Honig says. “He really engaged with me and with the company in this process and demonstrated the importance of internal critical review and taking responsibility for all of the relationships that one has to develop.”
Indeed, internal critical review and the importance of personal responsibility were two aspects of company creation that Dr. Honig struggled with early on. “We were one of the first tenants in Harlem Biospace, but we didn’t necessarily make the best use of the space initially… all of the concepts for our current business plan were there from the beginning, but what we didn’t have at the start was a step by step plan for how to get from A to B. Once we figured that out and started holding everyone accountable, things began to progress.”
Symbiotic Health is currently developing two products. Their first product is an oral capsule that uses gastrointestinal bacteria from healthy individuals to treat patients with Cdiff. One unique aspect of Symbiotic’s business model is that the company will be able to start treating patients before receiving FDA approval.
“In the special case of recurrent Cdiff, the FDA has created a particular exemption for the limited use of transplanted bacteria for treatment-resistant Cdiff therapy, and effectively what it means is that in practice it [treating patients with the oral capsules] is a medical procedure provided that we follow very specific guidelines.”
As a result, Symbiotic Health will be able to start generating early revenue and gathering early data on the effectiveness of its delivery mechanism. Although treating patients with healthy bacteria is well-established, Symbiotic’s innovation, and the basis of its intellectual property, is the development of a mechanism that can deliver healthy bacteria in a non-invasive manner.
The other arm of Symbiotic Health’s R&D strategy is to isolate which microbiome bacteria are effective therapeutics so that the company can develop a synthetic bacteriotherapy that can be put into a capsule and delivered to patients. This strategy will allow the company to forgo healthy donors and create more standardized capsules.
Symbiotic Health does much of its microbiology and chemistry research at Harlem Biospace, but the company also outsources to other small biotechs.
“It is a certain trend that as companies are developing products they have certain specific capabilities,” says Dr. Honig. “For instance, we outsource some of our work to Goddard Labs (our 1st Pitch Best in Show winner for April), and we work with another Harlem Biospace company, Girihlet.”
Over the next few months, Symbiotic Health will continue to refine its technology, develop clinical partnerships, and flesh out its team. The company recently brought on its first full time employee and is continuing to build out its scientific advisory board.
New York City has put forth a great effort over the last few years to help cultivate its biotech ecosystem, and Symbiotic Health has taken advantage of many of the programs offered. In addition to taking up residence in Harlem Biospace and taking part in ElabNYC, Symbiotic has participated in NYCEDC’s SBIR Impact program (a workshop designed to help early-stage companies write competitive SBIR grants), New York BIO’s Fellows Program for Life Science Entrepreneurs, is a member of Stony Brook’s Center for Biotechnology, and is a member of Accelerate Long Island.
So what is one of the greatest benefits these programs in New York have given Dr. Honig and Symbiotic Health?
“The major one is really frank, realistic assessment of our prospects and constructive suggestions on how to fix evident problems… the ability to subject your business plan concepts and technology to informed feedback in a setting where showing your flaws doesn’t close future doors to you is especially important.”
For aspiring bioentrepreneurs, Dr. Honig says you need four functions to build a successful startup: you need someone to decide what to do, secure resources, and to recruit the team (the CEO); you need someone to figure out what to sell (the CSO); you need someone to sell it (the commercial lead); and you need someone to make sure the product is delivered on time and within budget (the operations lead). While multiple functions may be covered by one person, all of these areas must be addressed for progress to be made.