TopiVert Pharma Limited: TopiVert completes TOP1630 preclinical development

LONDON, UNITED KINGDOM--(Marketwired - May 16, 2016) - TopiVert Pharma Limited

TopiVert completes preclinical development with TOP1630 for dry eye disease

• IND to be submitted in US in H2 2016
• Phase I/II study on track to commence in US in early 2017

London, UK, 16 May 2016: TopiVert Pharma Ltd ("TopiVert" or the "Company"), 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, announces that it has completed the preclinical development of TOP1630 for the treatment of dry eye disease. An investigational new drug (IND) application is being prepared for submission later in the year ahead of a planned Phase I/II study in the US which is on track to commence in early 2017.

TOP1630 is a potent, topical anti-inflammatory NSKI with minimal systemic uptake being developed for the treatment of dry eye disease, one of the most common ophthalmic diseases worldwide. In moderate to severe cases, sufferers commonly experience debilitating symptoms, including burning, irritation and blurred vision, which can have a considerable impact on quality of life. There is currently no adequate therapy available which effectively addresses both the signs and symptoms for dry eye disease sufferers.

Formulated as a simple eye drop solution for topical administration, TOP1630 has demonstrated excellent anti-inflammatory activity and shown to be at least as effective as topical steroids in preclinical models of disease. Steroids are established treatments for dry eye disease but their use is restricted, particularly in the long term, by significant safety issues. With excellent preclinical safety and minimal systemic uptake, TOP1630 promises to be a safe and effective topical treatment for dry eye disease. TopiVert is currently preparing to submit an IND to the US Food and Drug Administration (FDA) in the second half of 2016. Once approved, this would allow a planned Phase I-IIa study in dry eye disease patients to start in the US in early 2017, with results expected by mid-2017.

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