Zealand Pharma has reported positive topline data from the Phase III EASE 1 clinical trial of glepaglutide to treat short bowel syndrome (SBS) patients.
The double-blind, randomised trial analysed the safety and efficacy of 10mg of subcutaneous glepaglutide given once or twice a week versus a placebo.
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It enrolled up to 106 SBS patients with intestinal failure dependent on perenteral support (PS) for a minimum of three days each week.
The absolute variation in weekly parenteral support volume from baseline at 24 weeks was the trial’s primary endpoint.
According to the findings, subjects who received glepaglutide twice and once weekly had an average decline in parenteral support from baseline of 5.13L/week and 3.13L/week at 24 weeks, respectively.
The company noted that the once-weekly dose of glepaglutide offered a numeric decline in weekly parenteral support but did not meet statistical significance.
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By GlobalDataClinical response, as described by a subject having a minimum of 20% decline in weekly parenteral support volume from baseline at 20 and 24 weeks, was substantially greater for a twice-weekly dose of glepaglutide versus a placebo.
In the trial, 65.7% of subjects in the twice-weekly glepaglutide arm had a clinically meaningful response.
Glepaglutide was also reported to be safe and well-tolerated in the study.
A long-acting GLP-2 analogue, glepaglutide is being developed for subcutaneous delivery using an auto-injector to treat SBS.
Zealand Pharma chief medical officer David Kendall said: “We are particularly encouraged that a number of patients treated with glepaglutide were able to significantly reduce the burden of parenteral support, both reducing the number of days and completely eliminating the need for parenteral support in a substantial number of patients.
“We believe the outcome of this trial supports the potential of glepaglutide as an effective treatment for people living with SBS and intestinal failure and can reduce the burden of both parenteral support and daily dosing of GLP-2 treatment.”
A complex, chronic, and severe ailment, SBS is linked to lowered or complete intestinal function loss.
In March 2019, the company began treating subjects in a Phase III trial of dasiglucagon to treat congenital hyperinsulinism in children.
