Date: 2016-05-16
Type of information: Completion of the trial
phase: preclinical
Announcement: completion of the development
Company: Topivert Pharma (UK)
Product: TOP1630
Action
mechanism: kinase inhibitor. TOP1630 is a topical anti-inflammatory NSKI with minimal systemic uptake being developed
for the treatment of dry eye disease. NSKIs are a novel class of small molecules targeting key kinases which play pivotal roles as signalling molecules in multiple inflammatory pathways. Inhibition of this combination of kinases leads to potent and broad anti-inflammatory effects in both innate and adaptive immune responses. The compounds are specifically designed to prevent absorption into the circulation, thereby avoiding any propensity for systemic side effects.
Disease: dry eye disease
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On May 16, 2016, TopiVert Pharma, 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, announced 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 topical anti-inflammatory NSKI with minimal systemic uptake being developed for the treatment of dry eye disease. 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 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.
