TopiVert Pharma Ltd, focused on creating solutions for diseases such is dry eye syndrome, announced today 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 of the gastrointestinal (GI) tract and eye. NSKIs target several important kinases involved in the signalling cascade in inflammatory cells, leading to synergistic inhibition of key pathways involved in innate and adaptive immunities. TOP1630, TopiVert’s lead NSKI for ophthalmology, 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 has minimal systemic absorption, 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, TopiVert has said.
Furthermore, TOP1630 has the potential to provide rapid symptomatic relief together with long-term efficacy in the treatment of the signs and symptoms of DES. Following this IND approval, TopiVert is on schedule to commence a Phase 1/2a proof-of-concept study in the US in January 2017 to assess the safety and efficacy of TOP1630 in DES patients.
Steve Webber, TopiVert’s Chief Scientific Officer, commented: “The FDA approval of this study, enabling us to advance our second NSKI into the clinic, is a significant step for TopiVert. TOP1630 is our lead NSKI compound in ophthalmology and which 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 that we expect 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.”