"We believe vurolenatide may offer a simplified regimen for SBS patients, having demonstrated rapid onset and clinically meaningful improvements in total stool output in studies to date," Dr. Patrick Griffin, chief medical officer of 9 Meters Biopharma Inc, the Raleigh, North Carolina, company that is developing the drug, said in a news release.
Dr. Griffin presented the pharmacokinetics data at the American College of Gastroenterology annual meeting.
Patients with SBS suffer from intestinal malabsorption and diarrhea, and many require parenteral support because they cannot absorb enough fluids and nutrients from their intestines.
Vurolenatide is a novel GLP-1 analog that is linked to a biodegradable protein polymer that is designed to extend its half-life. The drug slows gastrointestinal transit time and decreases gastric emptying, thereby increasing the total amount of time for fluid and nutrients to be absorbed and reducing the total stool output and diarrhea.
"This GI-transit-control mechanism is referred to as restoring the ileal brake," Dr. Griffin said in a recorded poster presentation.
In the phase-1b/2a trial, nine patients with SBS received vurolenatide by subcutaneous injection at a dose of 50 mg, 100 mg or 150 mg on day one and day 15.
Repeated blood samples were obtained for pharmacokinetics studies. Patients were followed for 14 days after the second dose for adverse events and symptoms of malabsorption and for another six weeks for safety followup.
The pharmacokinetics results show that the mean half-life ranged from 300 to 750 hours independent of dose administered. "These data support twice monthly fixed dosing or better, indicating that vurolenatide may offer a convenient therapeutic regimen for all patients with SBS regardless of their post-surgical phenotype," Dr. Griffin said.
The company previously announced positive topline safety and efficacy results from this phase 1b/2a study, which showed that vurolenatide was generally safe and well tolerated, with clinically meaningful declines in total stool output (TSO) following each dose, relative to a baseline output, in all but one patient.
The average reduction in TSO was 42% from baseline in all nine patients at 48 hours after the first dose and 46% in seven of eight patients within 48 hours of the second dose, with overall improvements in general well-being.
SBS is a "horrible" condition and with vurolenatide, "a GLP-1 replacement therapy, we really think we have a jewel on our hands," John Temperato, chief executive officer of 9 Meters Biopharma, noted in a phone interview with Reuters Health (nine meters is roughly the length of the GI tract).
Results of this trial led to the advancement of vurolenatide into a phase-2 clinical trial known as the VIBRANT study, with topline results expected by the end of the year.
Vurolenatide has received orphan drug designation by the U.S. Food and Drug Administration (FDA).
SOURCE: https://acgmeetings.gi.org/ American College of Gastroenterology annual meeting, presented October 26, 2021.
By Megan Brooks
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