According to an article at PR Newswire, Bridge Biotherapeutics Inc., a South Korean biotechnology company, has announced the opening of three of its scheduled ten clinical study sites for the Phase 2 trial of their Ulcerative colitis drug candidate BBT-401.
About Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowl disease (IBD) affecting somewhere between roughly .008% and .246% of the population. It primarily affects the lining of the large intestine and rectum, causing enduring inflammation of the digestive tract along with the development of ulcers.
Most cases of UC are relatively mild, but severe cases can involve serious complications like bloody stool, fever, or even an inability to eat. Fatalities related to UC or other IBDs are rare, but they can occur – though these higher mortality rates seem to stem mostly from patients’ increased likelihood of experiencing complications arising from surgeries or medications that treat the underlying condition.
There is currently no cure for ulcerative colitis, though a number of treatments exist that can make living with the condition much more comfortable.
Bridge Biotherapeutics and BBT-401
BBT-401, then, represents the next stage of modern treatments – one of the many drug candidates that scientists hope might one day make it easier than ever for UC patients to manage their conditions.
If the name sounds more like a Star Wars droid than a mass-market medication, there’s a good reason why. When medications are early in their synthesis and testing, it pays not to be too attached to a given name. BBT-401 is about to enter phase II trials, which is right around where most drug candidates stall. When a pharmaceutical company slaps a name on something, it means they’re very confident about the product’s potential approval from the FDA. For BBT-401, it’s still too early to tell.
Three of the ten sites where Bridge Biotherapeutics plans to conduct its phase II trials are now open, with the remaining seven set to open early this year. With this phase of testing, Bridge scientists will attempt to discern whether or not BBT-401 produces quantifiable results in the treatment of ulcerative colitis. Most drugs that undergo clinical testing pass phase I, which merely assesses if the drug candidate is safe for human consumption. In other words, it’s been established that BBT-401 doesn’t hurt people in the intended dose – now scientists must prove that it actually helps people.
Obviously, there’s lots of work left to be done. Phase II and Phase III trials can take years to go through, and that’s assuming that everything goes according to plan for BBT-401 and Bridge Biotherapeutics. Experts remain hopeful for a more effective treatment for ulcerative colitis, but that could still be years away by any indication.
A lot of hype can evolve around drugs early in their development cycles, especially if their intended market is particularly in need. How might this help pharmaceutical development? How might it hamper it? Share your thoughts with Patient Worthy!