October 5th, 2020, TEL-AVIV, Israel — Tarsius Pharma, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, announced today that the GADOT 20/20 trial of its novel TRS01 drug for treating Active Anterior Non-Infectious Uveitis, demonstrated significant improvement in critical measures such as ACC (Anterior Chamber Cells), pain reduction and increased visual acuity.
The GADOT 20/20 trial was a dose-ranging, randomized, double-masked, controlled phase I/II clinical trial that evaluated the safety and efficacy of TRS01 in 16 subjects with active non-infectious anterior uveitis in the U.S. The study compared two different doses of TRS01.
Results showed a statistically significant improvement in the signs and symptoms of the disease, with the high-dose usage being superior to low-dose in a few important measures. Firstly, a consistent clearing of the anterior chamber cells (ACC) from baseline was achieved. Secondly, prompt resolution of pain was present, alongside increase of visual acuity. Also, compared to rescued subjects that received steroids, a reduction of IOP (intraocular pressure) was demonstrated in patients of both treatment arms.
“The results of this clinical trial with TRS01 are truly impressive, and suggest meaningful progress towards the development of a novel and clinically important class of ocular therapeutics – topical anti-inflammatory agents with efficacy that is at least equal to corticosteroids, but with none of the known corticosteroid-associated side-effects” stated Dr. Ron Neumann, Tarsius Pharma’s CMO.
Dr. Daphne Haim-Langford, Tarsius’ CEO, said: “the results of this study bring us one big step forward in our journey to save the eye-sight of patients with uveitic glaucoma, who have no approved treatment available today for this devastating condition. Completing this trial during the COVID-19 pandemic, proves once again the emergency nature of uveitis flare-ups. On behalf of our entire Tarsius team, I thank the investigators, volunteers, and all study team members for contributing to the professional execution and evaluation of the clinical process, and to the understanding of TRS01 in humans”.
About Ocular Inflammatory Diseases
Ocular inflammatory diseases impose a significant medical and economic burden on society, affecting hundreds of million people worldwide and posing severe risks of vision loss and blindness.
In more than 50 years, corticosteroids are the most common method used to treat ocular non-infectious inflammation of any kind. Rather than treating the disease itself, however, steroids merely relieve its symptoms, and long-term use can result in life-changing consequences.
The TRS Platform Technology has the potential to effectively treat a broad array of autoimmune and inflammatory ocular diseases. After a successful PoC which demonstrated TRS01’s safety and efficacy, Tarsius Pharma is well-positioned to advance its novel platform technology in other sight threatening ocular diseases.
About Tarsius Pharma
Tarsius Pharma was established in 2016 and is focused on developing TRS, a breakthrough, bio-inspired platform technology for the treatment of blinding ocular diseases.
This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 879598.