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Wednesday 07 August, 2019

Topivert Pharma Ltd

Top-Line Results from THEIA-1 Phase 2b/3 Trial

RNS Number : 1454I
Topivert Pharma Limited
07 August 2019

TopiVert Announces Top-Line Results from THEIA-1 Phase 2b/3 Clinical

Study of TOP1630 as a Treatment for Dry Eye Disease



London, UK, 7 August 2019: TopiVert Pharma Ltd ("TopiVert" or the "Company"), a clinical stage biotechnology company advancing innovative therapeutics to improve ocular health, today announces top-line results from 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, a multi-centre, randomised, double-masked, placebo-controlled phase 2b/3 study, investigated the efficacy and safety of TOP1630 0.1% Ophthalmic Solution compared to vehicle control (placebo) over a 4-week period in 202 adult patients with moderate to severe dry eye disease.


The primary endpoints of the study, the efficacy of TOP1630 0.1% Ophthalmic Solution compared to placebo at day 29 on ocular grittiness and total ocular surface staining, were not met. However, TOP1630 showed statistically and clinically relevant improvements on multiple prespecified endpoints compared to placebo including ocular discomfort, eye dryness and the Ocular Surface Disease Index (OSDI; Allergan Inc, Irvine, CA).


The study also showed that TOP1630 was safe and well tolerated with a low frequency of adverse drug reactions and a comfort profile following administration similar to placebo, as had been seen in an earlier trial.


Ajay Duggal, TopiVert's Chief Medical Officer, commented: 

"The primary endpoints for this study were selected based on the strength of data from a small single centre Phase 1/2 study. While we are disappointed that these were not met in this larger, multi-centre study, we believe that the positive and consistent effects seen on a number of the key pre-specified endpoints support efficacy with a competitive tolerability profile. As differences between TOP1630 and placebo were increasing over time from many of the assessments, it suggests that plateau has not been reached at 4 weeks and there may be greater effects to be seen with longer duration of treatment. We will be working with our scientific advisors in the coming weeks to design the next study and define our regulatory pathway going forward."


Dr Joseph Tauber, Tauber Eye Centre Kansas City, Consultant Ophthalmologist, said:

"The results from this study in patients with moderate to severe dry eye disease are encouraging with TOP1630 demonstrating clinically and statistically significant changes compared to placebo on many endpoints and a favorable tolerability profile. Given the high unmet need in moderate to severe dry eye disease, the multifactorial etiology of the disease and the heterogeneous patient population, the emerging profile of TOP1630 as a novel anti-inflammatory agent is promising."


Additional information about the THEIA-1 study, can be found at: ( Identifier: NCT03833388).





For more information, please contact:


TopiVert Pharma Ltd

Steve Webber, Chief Scientific Officer

Ajay Duggal, Chief Medical Officer

Anuj Madhok, Chief Business Officer


[email protected]

FTI Consulting

Simon Conway

+44 (0)20 3727 1000



About TopiVert

TopiVert is a clinical-stage biotechnology company advancing innovative therapeutics to improve ocular health. The Company's mission is to leverage its core expertise in inflammation to identify, develop and deliver novel therapeutics that bring meaningful benefits to patients with ocular disease. The Company's lead programme, TOP1630 for dry eye disease, has recently reported compelling results in a proof of concept study conducted in the US. The Company commenced operations in early 2012 and its investors include SV Health Investors, IP Group, NeoMed and Johnson & Johnson Innovation - JJDC, Inc.


About TopiVert's Kinase Inhibitors

TopiVert's proprietary kinase inhibitors are novel small molecules characterised by broad, potent anti-inflammatory activity with exceptional safety and tolerability. Specifically, TopiVert's kinase inhibitors target pivotal kinases that control pro-inflammatory cascades in both the innate and adaptive arms of the immune system. Simultaneous targeting of multiple inflammatory pathways leads to rapid down regulation of damaging inflammatory responses. TopiVert's kinase inhibitors are designed to have low systemic bioavailability so that exposure to the body's healthy tissues is reduced, thereby providing enhanced safety and tolerability. Together, these attributes position our candidates as ideal treatments for chronic inflammatory diseases where long term therapy requires sustained efficacy with no compromise on safety and tolerability.


About Dry Eye Disease

Dry eye disease, also known as dry eye syndrome, keratoconjunctivitis sicca or keratitis sicca, is a chronic inflammatory eye condition. It is also one of the most common ophthalmic diseases, with almost 19 million sufferers in the US alone and over 300 million worldwide2. Dry eye disease becomes more common with age, with a third of elderly people suffering from this ailment.


1 - Taylor et al; Clinical Ophthalmology 2019; 13: 261-275

2 - Market Scope®, 2013 Report on the Global Market for Dry Eye Products


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