TopiVert, 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).
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.
Ajay Duggal, Chief Medical Officer at TopiVert, 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"