Tarsier Pharma’s Positive End-of-Phase 2 Meeting with the U.S. FDA Sets Stage for TRS01 ...
TEL-AVIV, Israel, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Tarsier Pharma (doing business as Tarsius Pharma Ltd.), a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and received important feedback on its trial design and program for its TRS01 Phase 3 program in uveitis, including feedback on its nonclinical and CMC plans supporting submission of a New Drug Application (NDA) in the U.S. TRS01, the Company’s first clinical development candidate, is a novel immunomodulator drug for treating Active Anterior Non-Infectious Uveitis.
The pivotal Phase 3 study will be a randomized, active control, double masked, multi-center study of TRS01 1.0% in patients with noninfectious anterior uveitis, including patients with Uveitic Glaucoma. The Company anticipates initiating the trial in 2021.
“Our path forward for TRS01 to a future NDA submission is clear, and we are thrilled to be on track to initiate the first pivotal clinical trial next year,” said Zohar Milman, Chief Operations Officer at Tarsier Pharma. “We have begun preparations for our pivotal trials already and are manufacturing GMP batches to support our registrational trial. We look forward to further demonstrating the potential of TRS01 as the first and best-in-class molecule for treating the inflammation in Uveitic Glaucoma patients in our Phase 3 program.”
Tarsier previously announced positive results from its U.S. multicenter Phase 1\2 clinical trial (GADOT 20\20) of TRS01which demonstrated statistically significant improvement in signs and symptoms of Uveitis, such as decrease in ACC (Anterior Chamber Cells), achieving zero cells and prompt pain resolution, thus presenting efficacy similar to corticosteroids without any of the known negative corticosteroid-associated side effects.
About Tarsier Pharma
Tarsier 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 a wholly-owned subsidiary company of Sun Pharmaceutical Industries Limited, BioLight Life Sciences Ltd, as well as private investors and family offices. The company has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 879598.
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