TEL AVIV, Israel, June 22, 2020 – Tarsius Pharma, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics for treatment of ocular inflammation, today announced the completion of patient enrollment in the company’s Phase I/II trial of TRS01 in patients with active anterior non-infectious uveitis.
TRS01 is a Potential First-in-Class topical immune-modulator agent with a novel mechanism of action for treatment of ocular inflammation. This phase I/II trial (GADOT 20/20) is a dose ranging trial to evaluate the safety and efficacy of TRS01 in patients with anterior non-infectious active uveitis. After meeting the enrollment timeframe for the planned 10 patients in this trial, the enrollment window was prolonged to enable more patients to participate. At the end of the extended enrollment timeframe, thanks to the very dedicated study investigators, 16 patients were enrolled to the GADOT 20/20 trial. Tarsius Pharma expects to announce topline results from the trial in 2H 2020.
“The completion of enrollment for this trial marks yet another important milestone for Tarsius Pharma. Exceeding the enrollment target, despite the COVID-19 pandemic, proves again the emergency nature of uveitis flare ups and the urgent need to find better and safer treatment modalities for patients struggling with non-infectious uveitis,” said Daphne Haim-Langford, Ph.D, Chairwoman and CEO at Tarsius Pharma.
The GADOT 20/20 trial is the first step in transforming the way ocular inflammation is being treated. The company expects to complete all requirements toward commencing the Phase III trial early 2021.
“As an ophthalmologist who sees firsthand the disabilities and pain inflicted upon patients with anterior uveitis, I am excited to see TRS01 achieve this milestone, since it brings this innovative treatment option one step closer to the patients who need it,” said Ron Neumann, M.D. CMO at Tarsius Pharma, “I believe TRS01 could represent an important advancement in the treatment choices for non-infectious uveitis. My hope is that I, along with my colleagues, will have access to this novel topical therapy in the future.”
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.
Tarsius Pharma Ltd.
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.
The company’s investors include Sun Pharmaceuticals, a global pharmaceutical company, BioLight Life Sciences Ltd, as well as private investors and family offices. This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 879598.
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