28 February 2017
TopiVert commences Phase I study with oral TOP1288 in the treatment of ulcerative colitis
TopiVert Pharma Ltd (“TopiVert” or the “Company”), a clinical-stage biotechnology company developing Narrow Spectrum Kinase Inhibitors (NSKI) as novel, locally-acting medicines for the treatment of chronic inflammatory gastrointestinal and ocular diseases, today announces the successful 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 is an NSKI developed by TopiVert that targets several important kinases in the signalling cascade in inflammatory cells, leading to synergistic inhibition of key pathways involved in innate and adaptive immunities. Furthermore, TOP1288 has very low systemic bioavailability such that its activity is confined to the site of active disease in UC patients and providing an improved safety and tolerability profile.
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. Results from both oral and rectal studies are expected in the second half of 2017.
Ajay Duggal, TopiVert’s Chief Medical Officer, commented: “We are delighted to have commenced the clinical evaluation of an oral formulation of TOP1288, as our intended commercial presentation. The Phase I study will evaluate the ability to deliver TOP1288 to the colon by the oral route, as well as assessing safety and tolerability of the formulation. In parallel, a rectal formulation of TOP1288 is being evaluated in a Phase 2a study to demonstrate proof of concept in UC patients. Both studies will report in the second half of this year. Given the pressing need for improved treatments in UC, we are eager to see if TOP1288’s potent anti-inflammatory properties can bring clinical benefit to UC patients.”