TopiVert Pharma announced that the first patients have been dosed in the THEIA-1 phase 2b/3 clinical study evaluating TOP1630, a novel anti-inflammatory kinase inhibitor, as an ophthalmic solution for the treatment of dry eye disease.
THEIA-1 is a multicenter, randomised, double-masked, placebo-controlled phase 2b/3 study that will enrol approximately 200 adult patients with moderate to severe dry eye disease. The objective of the study is to assess the efficacy of TOP1630 0.1% ophthalmic solution, compared to placebo at day 29 on primary endpoints of ocular grittiness and total ocular surface (all-regions) lissamine green staining. TopiVert expects topline data to be available from THEIA-1 during H2 2019. The study has been designed to serve as the first US registrational study for TOP1630 in dry eye disease.
The initiation of THEIA-1 follows the recent publication of results from the positive proof of concept phase 2 clinical study of TOP1630 in dry eye disease in the peer reviewed journal Clinical Ophthalmology.1
“We are pleased to achieve this important milestone of dosing our first patients in the THEIA-1 phase 2b/3 clinical study,” Ajay Duggal, TopiVert’s Chief Medical Officer, said in a company news release. “We hope the study will build on the results from our clinical proof of concept study, which demonstrated encouraging evidence of TOP1630’s efficacy in treating both the symptoms and signs of dry eye disease along with placebo-like tolerability and a favorable adverse event profile. Importantly, this study is the first of two US pivotal trials that will potentially support US registration of TOP1630 as a treatment in this indication.”
“Despite the availability of several treatments for dry eye disease, there remains a substantial unmet medical need based upon the limited efficacy and significant tolerability issues experienced by many patients prescribed currently available therapies. TopiVert is focused on leveraging its core expertise in inflammation to identify, develop and deliver novel therapeutics that bring meaningful benefits to patients with ocular disease.”
Additional information about the THEIA-1 study can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03833388).
1 – Taylor et al; Clinical Ophthalmology 2019; 13: 261-275