Published 17th March 2016

Innovations portfolio company TopiVert reports successful Phase I clinical study for the treatment of ulcerative colitis

Imperial Innovations Group plc (AIM: IVO, 'the Group', 'Innovations') is pleased to note that portfolio company TopiVert Pharma Ltd ("TopiVert" or the "Company"), has today announced positive Phase I study results for TOP1288, its lead compound for the treatment of ulcerative colitis (UC).

TopiVert will present the Phase I study data at the 11th Congress of ECCO in Amsterdam on Friday 18 March 2016.

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 tract and eye. NSKIs are small molecules characterised by broad, potent anti-inflammatory activity together with minimal systemic exposure. These attributes make NSKIs ideal candidates for treatments in inflammatory diseases where long-term therapy demands a sustained effect accompanied by excellent safety and tolerability.

The Phase I study results reported today demonstrate that a rectal formulation of TOP1288, a potent inhibitor of key kinases involved in inflammation, has an excellent safety and tolerability profile in healthy volunteers and with only minimal systemic exposure. These results support the concept that NSKIs have the potential to produce sustained effects in mucosal tissues after local administration, but without the undesirable side-effects often seen in UC patients treated with systemically available therapies.

TopiVert now plans to start a Phase II proof of concept study with a rectal formulation of TOP1288 in UC patients in mid-2016, with results anticipated by mid-2017. This study is designed to determine if TOP1288 provides a clinical benefit in UC patients with active disease while avoiding significant exposure to healthy tissues outside the gastrointestinal tract.

TopiVert is also planning to start a Phase I study of an oral formulation of TOP1288 in the second half of this year. This is also anticipated to report in mid-2017. An oral product offers greater patient acceptability and convenience over a rectal formulation.

At 31 July 2015, the Group had a 30.6% interest in the issued share capital of TopiVert, with such interest having a net fair value of £7.5 million.

Maina Bhaman, Director of Healthcare Ventures, Imperial Innovations added:

"We are delighted with the progress the TopiVert team has made since commencing operations in 2012.

"These Phase I results represent a key clinical milestone and we are looking forward to seeing whether the potent anti-inflammatory effects observed with TOP1288 in preclinical testing translate into clinical benefits for patients."

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