Published 6th October 2016

First patients dosed in TopiVert's Phase IIa proof-of-concept study in moderate to severe ulcerative colitis

Imperial Innovations Group plc (AIM: IVO or 'the Group', 'Innovations') is pleased to note that portfolio company TopiVert Pharma Ltd ('TopiVert' or the 'Company') has today announced that the first patients have been dosed in its Phase IIa proof-of-concept study to evaluate the safety/tolerability and efficacy of a rectal formulation of TOP1288 in symptomatic ulcerative colitis (UC) patients with moderate to severe disease activity.

TOP1288, a potent inhibitor of key kinases involved in inflammation, is being developed by TopiVert as a topical therapy for UC, a form of inflammatory bowel disease (IBD) which affects the colon.

On 17 March 2016, TopiVert reported the successful completion of a Phase I study of a rectal formulation of TOP1288 in healthy volunteers. The clinical data support the concept that TOP1288 has the potential to produce sustained pharmacological effects in mucosal tissues after local administration, but without the undesirable side effects often seen in UC patients treated with systemically available therapies.

The new Phase II study will evaluate the efficacy, safety and tolerability of TOP1288 administered once daily for four weeks in symptomatic UC patients with moderate to severe disease activity. The study will recruit up to 60 patients at sites across eight European countries and is anticipated to report in the second half of 2017.

TopiVert will also commence a follow-on Phase I study with the oral formulation of TOP1288 in early 2017. This study is also expected to report in the second half of 2017.

Maina Bhaman, Director of Healthcare Ventures at Imperial Innovations, said:

"We are delighted by the progress that TopiVert is making, both in its ulcerative colitis trials, but also with its second programme, TOP1630, in dry eye disease, for which a first-in-human proof-of-concept study is planned for early 2017."

TopiVert is a clinical-stage biotechnology company developing Narrow Spectrum Kinase Inhibitors (NSKIs) as novel, locally-acting medicines for the treatment of chronic inflammatory diseases of the gastrointestinal (GI) tract and eye. As at 31 January 2016, the Group had a 30.6% interest in the issued share capital of the Company with such interest having a net fair value of £11.6 million.

Narrow Spectrum Kinase Inhibitors (NSKIs) are novel small molecules which specifically target a select range of kinases that mediate inflammatory disease and have topical, non-systemic availability to provide long-term safety and tolerability.