22 February 2017
TopiVert commences proof of concept study for TOP1630 in the treatment of dry eye syndrome
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 gastrointestinal (GI) and ocular diseases, today announces the successful dosing of the first patients in a Phase 1/2a proof of concept study in the US of TOP1630 ophthalmic solution for the treatment of dry eye syndrome (DES).
NSKIs target several important kinases in the signalling cascade in inflammatory cells, leading to synergistic inhibition of key pathways involved in innate and adaptive immunities. TOP1630, the Company’s lead NSKI for ophthalmology, has demonstrated an excellent efficacy in in vitro and in vivo pre-clinical inflammatory models where it was potent and had a fast onset of action. When administered as eye drops, TOP1630 is absorbed and retained in target inflammatory cells in the cornea and with only minimal systemic exposure, making it an ideal topical eye therapy.
TopiVert is initially developing TOP1630 in DES, a common inflammatory disorder of the front of the eye. Currently available treatments for DES have only limited efficacy in treating both the signs and symptoms of the disease and they often display side effects that include burning and stinging in the short term or lead to further complications in the long term. A major unmet medical need remains for a more effective and better tolerated therapy for this debilitating disorder. TOP1630 has the potential to provide rapid symptomatic relief together with long term efficacy in the treatment of the signs and symptoms of DES. The current study is expected to report in the second half of this year.
Ajay Duggal, TopiVert’s Chief Medical Officer, commented: “Advancing our second NSKI into the clinic is a major step forward for TopiVert. TOP1630, our lead NSKI in ophthalmology, is being developed for the treatment of dry eye syndrome, one of the most common inflammatory eye diseases. We expect results from this proof of concept study in the second half of 2017, around the same time as proof of concept data for TOP1288 in ulcerative colitis. This is an exciting time for TopiVert as it seeks clinical validation of its NSKI technology in two different inflammatory diseases.”