Theravance Biopharma recently proudly announced the results of a successful Phase 2b trial for their gastroparesis treatment, Velusetrag.
The results showed that this treatment safely and effectively improved symptoms and normalized gastric emptying in patients with diabetic and idiopathic gastroparesis.
Gastroparesis is a condition in which the stomach can not empty itself in a normal way.
The cause of gastroparesis is usually unknown, though it could be caused by a damaged vagus nerve. This will cause the muscles in the stomach and intestines to stop functioning properly. Thus, food will subsequently not be able to move through the body normally.
There are many unpleasant symptoms of gastroparesis, including heartburn, nausea, vomiting undigested food, feeling full quickly, abdominal bleeding, poor appetite or weight loss, and poor blood sugar control, but at the moment, there are few gastroparesis treatments out there to manage and control these symptoms.
Theravance Biopharma’s treatment, Velusetrag, is an oral 5-hydroxytryptamine receptor 4 agonist that was developed to treat gastrointestinal motility disorders. Back in December of 2016, the FDA fast-tracked this drug for the treatment of gastroparesis.
The hopeful Phase 2b study showed not only that Velusetrag aided gastric emptying, but also that the treatment significantly improved gastroparesis symptoms. The Chief Medical Officer of Theravance Biopharma is Dr. Brett Haumann, and he is very excited about Velusetrag.
In a press release, Dr. Haumann addresses the treatment and its effectiveness. He cited that the study found even a 5-mg dosage sufficient to help the symptoms of gastroparesis, which is clear evidence of the drug’s benefit.
So here’s how they did the 12-week study: study-conductors randomly assigned 232 patients to take placebo or 5 mg, 15 mg or 30 mg of the study drug in a once daily oral dose.
At the 4-week checkpoint, patients who were assigned 5 mg a day showed drastic symptom improvements compared to those who received the placebo. The improvement was measured on the Gastroparesis Cardinal Symptom Index and the Gastroparesis Rating Scale.
Additionally, patients assigned to the 5 mg dose showed significant gastric emptying improvement compared to those with the placebo. The higher doses, as well, showed meaningful improvements in gastric emptying compared with the placebo.
However, patients who received the two high doses (15 and 30 mg) did not see substantial improvement in symptoms. According to the Theravance Biopharma press release, this could have been caused by rapid emptying of the stomach in increased gastrointestinal side effects at these doses.
Regardless, the findings within the 5 mg dosage group are highly encouraging and Theravance Biopharma is looking forward to announcing these results in many upcoming scientific meetings. They are also looking towards their next phase of treatment development.
To read more about this possible new gastroparesis treatment in Healio, click this link.