Imperial Innovations Group Regulatory News (IVO)

RNS Reach

17 March 2016

Imperial Innovations Group plc

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."

-Ends-

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Notes to editors

About Imperial Innovations - www.imperialinnovations.co.uk 

Imperial Innovations Group plc ("Innovations") creates, builds and invests in pioneering technology companies and licensing opportunities developed from outstanding scientific research from the 'Golden Triangle', the geographical region broadly bounded by London, Cambridge and Oxford. This area has an unrivalled cluster of outstanding academic research and technology businesses, and is home to four of the world's top 10 universities, as well as leading research institutions, the cream of the UK's science and technology businesses and many of its leading investors.

Innovations supports scientists and entrepreneurs in the commercialisation of their ideas, through the licensing of intellectual property, by leading the formation of new companies, by recruiting high-calibre management teams and by providing investment and encouraging co-investment. Innovations remains an active investor over the life of its portfolio companies, with the majority of Innovations' investment going into businesses in which it is already a shareholder.

Since becoming a public company in 2006, Innovations has raised more than £430 million of equity from investors, which has enabled it to invest in some of the most exciting spin-outs to come out of UK academic research. In addition, the Group has agreed £80.0 million in loan facilities from the European Investment Bank (EIB).

Between Innovations' admission to AIM (August 2006) and 31 July 2015, Innovations had invested a total of £236.8 million across its portfolio companies, which had raised collectively investment of £1.3 billion.

About TopiVert Pharma Limited - www.topivert.com

TopiVert is a clinical-stage biotechnology company developing narrow spectrum kinase inhibitors as novel, locally-acting medicines for the local treatment of chronic inflammatory diseases of the gastrointestinal tract and eye.

TopiVert's most advanced drug candidate, TOP1288 for the treatment of ulcerative colitis, has successfully completed Phase I development and a Phase IIa proof of concept study is planned to commence in the middle of this year. The Company also plans to start the clinical development of TOP1630, its candidate for dry eye disease (DED), in early 2017. Current therapies for these debilitating diseases provide inadequate long-term control in a high proportion of patients and considerable unmet medical need remains.

The Company commenced operations in early 2012 and its investors include Imperial Innovations Group plc, SV Life Sciences, NeoMed and Johnson & Johnson Innovation-JJDC, Inc.

About Narrow Spectrum Kinase Inhibitors (NSKIs)

NSKIs are novel small molecules characterised by relatively broad, potent anti-inflammatory activity and only minimal systemic exposure. Specifically, NSKIs are potent inhibitors of a select range of pivotal kinases involved in inflammatory cascades of both innate and adaptive immunity. Simultaneous targeting of multiple inflammatory components leads to a synergistic activity profile with broad anti-inflammatory effects. The NSKIs are designed to have low bioavailability to reduce their exposure to many of the body's healthy tissues, thereby enhancing their safety and tolerability profiles. Together, these attributes make NSKIs ideal treatment candidates for chronic inflammatory diseases where long term therapy demands a sustained effect accompanied by excellent safety and tolerability.