Closely-held Glyscend Therapeutics reported that Phase 1 and Phase 2a clinical trials demonstrated that the novel mechanism of its lead candidate, GLY-200, offers significant and clinically relevant reductions in postprandial glucose and body weight, and support its advancement into a Phase 2b clinical trial.
In the Phase 2a study, 51 patients with Type 2 diabetes received oral GLY-200 or placebo twice-daily for 14 days with one week follow-up. Data from the study showed that GLY-200 treatment resulted in statistically significant reductions in postprandial glucose in response to standardized meals; statistically significant reductions in body weight; reductions in food intake during ad libitum meals; and improvements in appetite assessments during ad libitum meals.
In addition, GLY-200 was well-tolerated with no treatment-related safety signals, and pharmacokinetic data were consistent with a gut-restricted non-absorbed polymer drug.
“These Phase 2a data provide clinical evidence that duodenal exclusion may be possible with a non-invasive, orally administered, pharmaceutical treatment,” Ashish Nimgaonkar, M.D., founder and CEO of Glyscend, said in a statement.
“We believe GLY-200 has first-in-class potential to offer patients and physicians an additive or alternative option in their diabetes and obesity treatment toolboxes, and we look forward to advancing into Phase 2b.” he added.
