A small, vibrating pill designed to help people with chronic constipation cleared a clinical study and is headed to the FDA for final review.
Vibrant Gastro is putting forward its approach as a drug-free alternative for infrequent or difficult bowel movements.
Swallowed along with a glass of water, the disposable pill—about the size of an everyday multivitamin—aims to do more than simply shake up any possible blockages. The device is designed to also help reset the connection between the gut and the brain’s circadian rhythm.
As it travels through the digestive system, its vibrations help stimulate the colon’s involuntary contractions, with the ultimate goal of resyncing them with the body’s biological clock to improve regular bowel movements after one to eight weeks of use. The pill’s progress can also be tracked via a companion smartphone app.
Among 312 participants, 39% reported at least one additional complete bowel movement per week, compared to 22% of those given a placebo pill. Over 22% logged two or more, versus 11% in the control group.
The study also recorded no severe side effects, including treatment-related diarrhea or nausea, according to the company. At the same time, the data also showed improvements in stool consistency and reported quality of life.
“The goal of Vibrant is to address a significant unmet treatment problem in chronic constipation, which has made life very challenging for those who suffer from it,” said Satish Rao, M.D., Ph.D., a professor of medicine at Augusta University, who was one of the primary investigators of a phase 3 study presented at the annual Digestive Disease Week conference.
Israel-based Vibrant estimates that as many as 35 million people in the U.S. suffer from chronic constipation. The company raised $7.5 million in a March 2021 series E round led by Unorthodox Ventures.
By Conor Hale
Source: fiercebiotech.com
The company plans to pour more than $500 million in additional funds into its active pharmaceutical ingredient (API) plant in Raheen, Limerick County, the country’s Industrial Development Agency (IDA) said. The new funding brings the company’s total investment in the site to 927 million euros ($1 billion).
“If in 2005 someone told you that two-thirds of our industry would be driven on the R&D side by emerging biopharma—it would be unthinkable. If one were to project that trend forward, what it would suggest is that we could have a day when we do this talk, say in 2027 or 2028, where 80% of the industry’s pipeline is coming from emerging companies.”
The German healthcare and agrochemicals giant told Reuters that in future its pharma pipeline will focus on cardiovascular disease, neurology, rare diseases and immunology, while de-emphasizing women’s health, a field it first focused on with the acquisition of the former women’s health specialist Schering in 2006.
