First patients dosed in TopiVert's Phase IIa study

RNS Reach

6 October 2016

Imperial Innovations Group plc

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.

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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 £440 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 - www.topivert.com

TopiVert is a clinical-stage biotechnology company developing narrow spectrum kinase inhibitors as novel, locally-acting medicines for the treatment of chronic inflammatory diseases of the gastrointestinal tract and eye. The Company's most advanced drug candidate, TOP1288 for the treatment of ulcerative colitis, is currently in Phase 2 development, with a Phase 2a proof of concept study due to report in the second half of 2017. TopiVert also expects 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, SV Life Sciences, NeoMed and Johnson & Johnson Innovation-JJDC, Inc.