RedHill Biopharma Ltd – ADR (RDHL) GI Topline Is Set For 2016 Release

RedHill Biopharma Ltd – ADR (NASDAQ:RDHL) just informed markets that it intends to put out topline data from its phase III trial of Bekinda in a gastroenteritis indication. Gastroenteritis is a potentially huge target market, and if the company can come out with some data that supports efficacy, there’s plenty of upside potential ahead of an NDA submission.

Here’s a look at the drug in question, and what we are looking for from the trial data.

Bekinda is a reformulation of a drug that is currently available (and widely used) called ondansetron. It’s on the WHO list of essential medicines, and is primarily used to tackle nausea and vomiting in cancer patients that have undergone chemotherapy. It’s also used in the indication in question, however, gastroenteritis. The current version is available as an oral medication, as an IV administration or a muscle injection. It’s what’s called an antiemetic, which is just the generic term used for drugs that are effective in these sorts of indications, and in this instance specifically, it’s a serotonin 5-HT3 receptor antagonist.

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We don’t need to go in to too much detail on the science of this one (there’s plenty of resources online available for those looking for some further clarity) but we will say that serotonin is thought to be responsible for the agitation of what are called vagal afferents. These are what are responsible for the initiation of the vomiting reflex. By antagonizing the serotonin 5-HT3 receptor, serotonin release is reduced, and there’s not as much vagal afferent stimulation. This, in turn, means the vomiting reflex isn’t activated.

Bekinda is an oral administration version of this particular antiemetic. But wait – if there’s already an oral generic available, why id RedHill developing its own? Well, the currently available version requires regular daily dosing (generally three times a day) in order to maintain efficacy across the waking period. RedHill is developing Bekinda as a once daily oral administration version. Patients sticking to a dosing regimen can be a big issue, and by bringing a once daily dosing version to market, RedHill Biopharma Ltd – ADR (NASDAQ:RDHL) is hoping it can compete for a decent potion of the gastroenteritis market.