Imperial Innovations Group Regulatory News (IVO)

RNS Reach

28 November 2016

Imperial Innovations Group plc

Portfolio company TopiVert receives IND approval for TOP1630 in the treatment of dry eye syndrome

Imperial Innovations Group plc (AIM: IVO, 'the Group', 'Innovations') notes that portfolio company TopiVert Pharma Ltd ('TopiVert' or the 'Company') has today announced that its Investigational New Drug (IND) application for the evaluation of TOP1630 ophthalmic solution as a treatment of patients with dry eye syndrome (DES) has been approved by the US Food and Drug Administration (FDA).

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. Approval of this IND will allow TOP1630 to enter the clinic in the US in a Phase I/IIa proof-of-concept study in DES. TOP1630 will be TopiVert's second compound to enter the clinic, following TOP1288, which has successfully completed Phase I evaluation and last month started a Phase IIa proof-of-concept study in patients with ulcerative colitis (UC).

DES is a common inflammatory disorder of the front of the eye. Currently available anti-inflammatory treatments have limited efficacy and often display side-effects that include burning and stinging in the short-term or lead to further complications with prolonged use.

TOP1630 has demonstrated an excellent activity profile in in vitro and in vivo pre-clinical inflammatory models where it was shown to be potent and have a fast onset of action. When administered as eye drops, TOP1630 is taken up and retained by target inflammatory cells in the cornea but with minimal systemic absorption, making it an ideal topical eye therapy with the potential to provide rapid symptomatic relief, together with long-term efficacy.

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 this second programme in dry eye syndrome. 

"There is major unmet medical need for an effective and well-tolerated therapy for this debilitating disorder. We are looking forward to seeing the results from this study in the second half of 2017, which is around the same time as proof-of-concept data for TOP1288 in ulcerative colitis will be published."

As at 31 July 2016, the Group had a 29.5% interest in the issued share capital of the TopiVert with such interest having a net fair value of £12.6 million.

For further information contact:

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 2016, Innovations has invested a total of £306.7 million across its portfolio companies, which have raised collectively investment of £1.5 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 a Phase IIa proof of concept study which is 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.

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 immunities. Simultaneous targeting of multiple inflammatory components leads to a synergistic activity profile with broad anti-inflammatory effects. The NSKIs are designed to have low systemic bioavailabilities, 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.