One hundredth Patient Enrolled in Clinical Trial of World's First 2-in-1 Anti-Diarrheal/Oral Rehydration Solution

NORWOOD, Mass., Nov. 16, 2021 /PRNewswire/ -- Nuvara Therapeutics, a clinical stage biotech company pioneering a new modality of protein regulation, announced the enrollment of the one hundredth patient in a Phase II, randomized double blind clinical trial for infectious diarrhea at the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR-B). The ICDDR-B is a world-renowned institution, long known for ground-breaking diarrheal disease research.

Stephen Gatto, Executive Chairman, discussed the significance: "Diarrheal disease is the second leading cause of death in children under five years old, and is responsible for killing around 525,000 children every year.¹ In the past, severe dehydration and fluid loss were the main causes of diarrhea deaths. Now, other causes such as septic bacterial infections account for an increasing proportion of all diarrhea-associated deaths. Children who are malnourished or have impaired immunity due to malabsorption and gut-barrier defects are most at risk of life-threatening diarrhea, yet there have been only modest advancements in treatment methodologies over the last 40 years and virtually all of them begin with a glucose-based solution." Gatto explained that glucose based oral rehydration solutions (ORS), the current standard of care, has been shown to exacerbate diarrhea and, while effective at treating dehydration, does nothing to reduce the incidence or length of the diarrhea itself. "We believe VP-002 can become the first dual action anti-diarrheal/oral rehydration solution, which can address both the need for fluids as well as an ability to shorten the duration of the diarrhea itself." Nuvara's proprietary formula developed with Gastroenterologists may also provide protection against the chronic effects of diarrhea and malabsorption leading to improved health and wellness. "We can and need to do better for these kids," he continued. "This has a life-time impact on health…you can't go back in time and undo the damage."

Sr. Vice President of Research & Development Dr. Robert Kenefick believes that a successful trial would "transform the standard of care by treating the diarrhea, shortening its duration, and replacing lost fluids better than traditional ORS."  Dr. Kenefick explained that COVID-19 has presented many challenges, including patients afraid to travel and the closure of public transportation systems. Despite these challenges, Nuvara was able to accrue patients 3 times faster than planned. "To me, this speaks to the prevalence and the huge unmet need," said Kenefick. "Not only do we want to save lives, but we also want these children to have better lives–that's what drives us." He added that the formula would have potential to be used for other age groups and other conditions.

When successful, the formula would be the world's first 2-in-1 non-glucose, anti-diarrheal/oral rehydration solution. The first data readout is expected in June 2022, and the final readout is expected in March 2023. A successful clinical outcome would deliver a major demonstration of Nuvara's protein modulation platform's successful translation to humans, according to Gatto. "Many children in developing nations are at grave risk from infectious diarrhea. We can help."

About Nuvara Therapeutics
Nuvara Therapeutics is a next generation, clinical stage therapeutics company targeting epithelial transmembrane protein (ETP) dysregulation that causes serious gastrointestinal and respiratory diseases. The company is the first to discover that novel combinations of prescription amino acids (RxAAs™) can modulate ETPs via cell signaling to treat disease. With its highly customizable platform, Nuvara Therapeutics is leading the way in addressing serious disease states with high unmet needs, including potentially groundbreaking treatments for Cystic Fibrosis—Class 1 Mutation, ARDS, Asthma, COPD, Diarrheal Diseases, and constipation.

Nuvara's technology originated from a $40M NASA | BARDA grant to study GI toxicity effects during long duration space travel.  The company was created to leverage technology in-licensed from Entrinsic Bioscience to focus on novel drug development.

http://nuvararx.com/

¹ World Health Organization. (2017, May 2). Diarrhoeal Diseases. Newsroom. Retrieved fromhttps://www.who.int/new-room/fact-sheets/detail/diarrhoealdisease. 

Contact: Joe Del Regno, [email protected]

SOURCE Nuvara Therapeutics