Tarsius Pharma Achieves Positive Results in Proof of Concept Study for TRS01 Targeting Uveitis
Tarsius Pharma announced that the GADOT 20/20 trial of its novel TRS01 drug for treating active anterior noninfectious uveitis, demonstrated significant improvement in critical measures such as Anterior Chamber Cells, pain reduction and increased visual acuity.
The GADOT 20/20 trial was a dose-ranging, randomized, double-masked, controlled phase 1/2 clinical trial that evaluated the safety and efficacy of TRS01 in 16 subjects with active noninfectious anterior uveitis in the United States. 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. Second, prompt resolution of pain was present, alongside increase of visual acuity. Also, compared to rescued subjects that received steroids, a reduction of IOP 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,” Dr. Ron Neumann, Tarsius Pharma’s CMO, said in a company news release.
“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,” Dr. Daphne Haim-Langford, Tarsius’ CEO, said in the news release. “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.”