Business
Tarsus Pharmaceuticals, Inc. Announces Type C Meeting with FDA Regarding NDA Submission Requirements for Lead Candidate TP-03
The Company began enrolling patients in Saturn-1 in September 2020 and expects to initiate its second pivotal registration trial, Saturn-2, in 2021 IRVINE,
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"The Company began enrolling patients in Saturn-1 in September 2020 and expects to initiate its second pivotal registration trial, Saturn-2, in 2021\nIRVINE, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage biopharmaceutical company whose mission is to discover and deliver breakthrough treatments to transform the lives of patients with common and poorly treated diseases, starting with the eye, today announced that it received written minutes from the (Type C) meeting held on December 8 with the United States Food and Drug Administration (FDA). The meeting was held to align on specific NDA submission requirements for TP-03, a novel therapeutic in development for the treatment of Demodex blepharitis, and the Company believes it received collaborative and productive guidance. “Recently, we held a productive Type C meeting with the FDA. At this meeting, we obtained valuable feedback on the data requirements for an NDA filing consistent with our existing plans: specifically, regarding the non-clinical toxicology, clinical and CMC components,” said Sesha Neervannan, COO of Tarsus. “We are pleased to continue advancing TP-03 through its pivotal trials and towards a potential NDA filing in order to provide the more than 9 million people in the United States that suffer from Demodex blepharitis a potential therapeutic treatment option.” Recently, Tarsus completed its Io and Europa Phase 2 clinical trials, and began enrolling patients in Saturn-1, its Phase 2b/3 pivotal trial. The company plans to initiate its second pivotal registration trial, Saturn-2, in 2021, and expects for the data to support the potential submission of an NDA for TP-03 to treat Demodex blepharitis. TP-03 has the potential to be the first FDA-approved therapeutic and standard of care for the treatment of Demodex blepharitis. About TP-03TP-03 (lotilaner ophthalmic solution 0.25%) is a novel therapeutic designed to target and eradicate Demodex mites. It is a potent, non-competitive antagonist of insect and arachnid GABA-Cl channels and a highly lipophilic molecule, which may promote its uptake in the oily sebum of the hair follicle where the mites reside. TP-03 has completed four Phase 2 clinical trials in Demodex blepharitis, all of which met their respective endpoints. It was well-tolerated with no significa...