TopiVert Pharma, a clinical-stage biotechnology company developing Narrow Spectrum Kinase Inhibitors (NSKIs) for chronic inflammatory gastrointestinal (GI) and ocular diseases, has announced results from its Phase 1/2a proof of concept study of TopiVert’s TOP1630 ophthalmic solution.
TopiVert’s TOP1630 is a treatment for the dry eye syndrome (DES) which improved multiple symptom and sign endpoints in both an environmental setting and in the Controlled Adverse Environment challenge. Furthermore, the company said that TOP1630 showed excellent safety and placebo-like tolerability and comfort profiles.
TopiVert said that, in the study, TOP1630 delivered statistically significant results across multiple signs and symptoms endpoints in DES starting at day 15, the first study assessment point. All analyses reported are pre-specified. Symptoms showing significant improvements for TOP1630 versus placebo included improvement in worst DES symptom, ocular discomfort, grittiness/foreign body sensation and ocular pain. All regions of ocular surface, corneal sum and conjunctival sum staining improved with TOP1630 compared to placebom with each p<0.05.
There were no safety findings, with TOP1630 shown to be safe and very well tolerated with a placebo-like profile. Importantly, this included no noticeable instillation site pain and discomfort.
Professor John Sheppard, Professor of Ophthalmology, Eastern Virginia Medical School said that the study showed consistent effects across both signs and symptoms, with placebo-like tolerability. He said that those characteristics define “a very promising benefit-risk profile, and therefore highly likely to prove beneficial to patients and desirable for prescribing eye care providers.”
Ajay Duggal, TopiVert’s Chief Medical Officer, said that TOP1630, the company’s lead NSKI in ophthalmology, has delivered compelling data in a Phase 1/2a proof of concept study for the treatment of dry eye syndrome. “We believe that the consistency of effect demonstrated across a range of sign and symptom endpoints, from multiple assessment scales and all from pre-specified analyses, coupled with the placebo-like tolerability profile sets a new benchmark for DES treatments. This exciting programme is now ready for late stage development in an area of high unmet medical need.”
What is DES
DES is a common inflammatory disorder of the front of the eye associated with considerable morbidity. A major unmet medical need remains for a more effective and better tolerated therapy for this debilitating disorder which affects over 300 million worldwide. TOP1630 has the potential to provide rapid symptomatic relief together with long term efficacy in the treatment of the signs and symptoms of DES.