TopiVert Pharma has finished dosing of the first subjects in a Phase 1 study of its oral formulation of TOP1288 for the treatment of ulcerative colitis (UC).
UC is a form of inflammatory bowel disease (IBD) affecting the colon. As many as 40% of patients fail to respond to current drug therapy, which is often poorly tolerated, and approximately 20% of patients require surgical removal of the colon to manage the disease.
TOP1288, as the company explained, targets several important kinases in the signalling cascade in inflammatory cells, leading to synergistic inhibition of key pathways involved in innate and adaptive immunities.
The Phase 1 study is designed to assess the safety, pharmacokinetics and pharmacodynamics of TOP1288 when delivered orally in healthy volunteers. A Phase 2a proof of concept study of a rectal formulation of TOP1288, which is ongoing in Europe, aims to demonstrate the efficacy and safety of the compound in the treatment of UC when the drug is delivered directly to the site of disease in the colon. This POC study with a rectal formulation is intended to guide the development of an oral formulation of TOP1288 as the intended commercial presentation, the company said.
Results from both oral and rectal studies are expected in the second half of 2017.