Glyscend Therapeutics has concluded the Phase I clinical trial for its oral, gut-restricted, polymer therapeutic, GLY-200, to treat type 2 diabetes (T2D).
A mucin-complexing polymer (MCP), GLY-200 boosts the natural mucus barrier in the duodenum or the upper small intestine.
This improved barrier causes a pharmacologic ‘duodenal exclusion’ that could non-invasively and safely reproduce several advantageous effects of metabolic surgery in patients with various metabolic disorders, including T2D.
This approach aids in preventing the complications linked to surgeries and procedures that are invasive.
The single and multiple ascending dose (SAD/MAD) Phase I trial enrolled a total of 64 healthy adult subjects to assess the safety and tolerability of oral GLY-200.
Findings showed that GLY-200 was found to be well-tolerated across all tested dose levels without any safety signals and serious adverse events seen.
The common adverse events reported in the trial were mild dose-dependent gastrointestinal symptoms.
Based on this data, Glyscend intends to file an investigational new drug (IND) application with the US Food and Drug Administration.
The company also intends to initiate Phase II development in T2D patients in the middle of this year.
Glyscend is also using its MCP platform to broaden its pipeline to include programmes for topical GI as well as systemic, inflammatory and autoimmune ailments.
Further uses of the technology including usage in polymer-drug conjugates for new GI tract targets and to boost oral peptide therapies’ bioavailability are being analysed.
Glyscend Therapeutics president and CEO Ashish Nimgaonkar said: “Metabolic surgery can lead to immediate and significant improvements in glycemic and lipid control, but its cost and risks continue to limit widespread use.
“Our goal at Glyscend is to leverage our proprietary MCP platform and extensive insights into gastrointestinal disease to build upon the disease-modifying effects of metabolic surgery.”