RTP’s KNOW Bio Forms Digestive Health Therapeutics Subsidiary

KNOW Bio, LLC, a Durham life science incubator, is merging its gut instinct with the scientific method.

It’s pursuing a belief that its nitric oxide-based (NO) platform has therapeutic applications for conditions of the gastrointestinal tract.

It is already developing a therapy from the platform of NO-based work of Mark Schoenfisch, Ph.D., to treat lung infections through its subsidiary Vast Therapeutics. Now it has created a new operating subsidiary to extend that work into gastroenterology.

Formation of Digestive Health Therapeutics, Inc., culminates almost a year of successful testing in vitro (laboratory) and in vivo (animals) with a large pharmaceutical partner, according to an exclusive NCBiotech interview with John Oakley, chief financial officer. He would not disclose the name of the pharma partner yet, however.

Oakley said the therapy in development will initially target achalasia, a rare but serious condition with no cure. It involves a constriction of the lower esophagus where it joins the stomach, as a result of nerve damage from an autoimmune condition. Suffers experience backups of food and liquids because the material cannot pass from the esophagus into the stomach. According to the Cleveland Clinic, about 3,000 people each year suffer from achalasia and the cause is not fully understood.

“Achalasia is known to be associated with nitric oxide deficiency,” said Oakley. So the company is pursuing the theory that its NO technology may help dilate esophageal constriction.

Nitric oxide has far-reaching therapeutic possibilities

NO is instrumental in successful therapies already where dilation of blood vessels is needed. The Nobel Prize for Medicine and Physiology 1998 was awarded to three American pharmacologists: Robert Furchgott, Louis Ignarro and Ferrid Murad for their work on NO as a signaling molecule in the cardiovascular system. It is what makes nitroglycerin the lifesaving vasodilator. The drug Viagra similarly prompts the vasodilation mechanism of NO within the body to increase blood flow in the treatment of erectile dysfunction.

Oakley went on to explain the additional benefit of using NO as an anti-infective to bolster the effectiveness of existing antibiotics, because it does not harm the good bacteria in the digestive tract that are so necessary for good health. This makes the company’s NO therapies promising as an adjuvant (add-on) treatment for staphylococcus (staph) infections in the gut, which are increasingly becoming more antibiotic resistant.

"KNOW Bio's strategy is to expand our technology into therapeutic areas based on the likelihood nitric oxide can benefit patients with unmet or underserved medical needs,” said Neal Hunter, managing director and CEO of KNOW Bio.

“Conditions and dysfunctions of digestive health impose a significant burden on human health, as they tend to broadly impact the overall well-being of patients,” added Stephen DeCherney, M.D., MPH, professor of medicine in the Division of Endocrinology at the UNC School of Medicine and a director of KNOW Bio. 

Experienced team of business, scientific experts

Schoenfisch is both a professor of chemistry at the University of North Carolina at Chapel Hill and a director of KNOW Bio. He is the inventor of multiple macromolecular NO-release systems and an active entrepreneur. He has spent 20 years working with NO chemistry and published more than 100 peer-reviewed articles on the synthesis, characterization and application of NO-modified biomaterials. He co-founded Novan, which leverages NO to treat dermatological and oncovirus-mediated diseases, and helped to guide it to an IPO.

Hunter was a co-founder of Cree, Inc., the LED lighting and technology giant, and served as its CEO and chairman from 1994-2001 and chairman until 2005. Prior to joining the UNC faculty, DeCherney, who also has authored or co-authored over 100 publications, served as president of global clinical research and chief innovation officer at Quintiles, which is now IQVIA.

Vast Therapeutics, which is developing an NO-based therapy to address serious lung infections common to sufferers of cystic fibrosis, recently closed $15 million in Series A financing and received a $300,000 grant from the Cystic Fibrosis Foundation to continue its work.

Oakey said Digestive Health will remain lean in terms of employee size in the near term, hiring perhaps two scientists in the next six months and growing total employees to “the high single digits within the next year.” Vast currently has nine employees. KNOW Bio has no plans to expand its local facility, but rather to spread into currently unused laboratory space.