Xeris Pharmaceuticals Inc (NASDAQ:XERS) announced on Friday last week that it observed positive results from a proof-of-concept phase 2 study involving its ready-to-use (RTU) glucagon. The latter has been in the pipeline as a developmental treatment for patients with postprandial hypoglycemia after going through bariatric surgery.
“Post-bariatric hypoglycemia (PBH) is a rare complication of bariatric surgery that can significantly diminish the quality of life for those affected,” stated Dr. Helen Lawler
The phase 2 study featured an in-clinic stage, an outpatient stage that lasted 12 weeks, and 12 patients were involved in it. The results of the phase 2 trial indicated that patients experienced over 200 postprandial hypoglycemia episodes in the two treatment cohorts. The episodes reportedly occurred between 90 minutes and 120 minutes after meals, and the subjects managed to administer themselves with the RTU glucagon when the episodes occurred.
The findings from the outpatient stage were also consistent with the findings from the in-clinic stage. This means that 300 µg RTU glucagon proved to be an adequate dose for patients to restore their blood glucose to normal levels in less than 15 minutes after the dose is administered. The findings also demonstrated the ability to maintain normal levels up to two hours.
Subjects that were in the placebo division of the study were given glucose tablets before and after the placebo was administered. The glucose tablet administration resulted in rebound hypoglycemia, and this was not observed in the subjects that were administered with the RTU glucagon.
Some adverse effects were observed in the clinical trial. Nausea was one of the most common adverse effects that were observed in the study. Some of the subjects also experienced vomiting, but there were no serious adverse effects. Nevertheless, the findings from the clinical study are a step in the right direction and especially for the patients. If the drug is approved and it reaches the commercial stage, it will be of great advantage for postprandial hypoglycemia patients because it will introduce more treatment options in an underserved area.