Published 28th November 2016

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.