• 26 June 2017
    TopiVert completes three clinical studies which will deliver proof of concept data for its two lead NSKI programmes in ulcerative colitis and dry eye syndrome

    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 completion of three clinical studies TV02, TV03 and TV04, which are all on course to report later in the year. 

    TV02 is a Phase 2a study designed to demonstrate proof of concept (POC) for TOP1288 in the treatment of patients with moderate to severe UC when administered as an enema. This topical enema formulation has been developed to ensure the drug is presented directly to the site of the disease in the colon to demonstrate POC. The primary efficacy endpoint is endoscopic remission. TV03 is a Phase 1 study assessing the safety, pharmacokinetics and pharmacodynamics of TOP1288 delivered orally in healthy volunteers. The results from these studies will help guide the forward development of an oral formulation of TOP1288 as the intended commercial presentation in the treatment of inflammatory bowel disease (UC and Crohn’s disease).

    TV04 is a Phase 1/2a proof of concept study of TOP1630 ophthalmic solution (eye drops) conducted in patients with dry eye syndrome (DES). The study is evaluating the safety and tolerability of the formulation along with multiple assessments of efficacy for both signs and symptoms of the disease. Results from this study are also expected later this year.

    Ajay Duggal, TopiVert’s Chief Medical Officer, commented: “We are delighted with the progress made in delivering all three clinical studies for TOP1288 and TOP1630, our lead NSKI programmes in IBD and ophthalmology respectively. These studies will report later this year and the results will guide the further development of these exciting NSKI programmes as potent topical, anti-inflammatory treatments. This is an exciting time for TopiVert as it seeks clinical validation of its NSKI technology in two different indications both with high unmet medical needs.”