• 18 May 2015
    Topivert starts Phase I Clinical Trial with lead compound, TOP1288, in Ulcerative Colitis

    TopiVert Pharma Ltd (“TopiVert” or the “Company”), a clinical-stage biotech focused on the local treatment of serious inflammatory diseases, today announced the start of a Phase I study with its lead compound, TOP1288, in ulcerative colitis (UC).

    TOP1288 is a Narrow Spectrum Kinase Inhibitor (NSKI). NSKIs are a novel class of small molecules with specific characteristics designed to deliver local effects in inflammatory cells whilst avoiding significant systemic exposure. 

    TOP1288 is being tested initially in a Phase I study, including volunteers and UC patients, to examine safety and tolerability of a rectal formulation as well as to explore predictive biomarkers for use in later studies.  The trial, conducted at a specialist centre in London, is the first part of a programme to deliver a novel oral and rectal anti-inflammatory treatment for patients with UC. The trial will report in 2016. 

    UC is a relatively common inflammatory disease affecting the large bowel and around 40% of patients fail to respond fully to current drug therapy, which can also be linked to significant side effects.  The disease can be serious enough to require surgery to remove the diseased colon in some patients. 

    Dr Steve Webber, Chief Scientific Officer of TopiVert, said “We are pleased to reach the clinic so quickly with our lead compound which has significant potential to help patients with this debilitating condition."