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Tarsus Completes Enrollment for the Pivotal Phase 3 Saturn-2 Trial of TP-03 to Treat Demodex Blepharitis and Secures $175 Million Credit Facility
Topline data expected in April 2022 from Saturn-2, the second Phase 3 pivotal trial of TP-03 and NDA submission remains on track for this year Credit facility
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"Topline data expected in April 2022 from Saturn-2, the second Phase 3 pivotal trial of TP-03 and NDA submission remains on track for this year Credit facility with Hercules Capital and Silicon Valley Bank provides availability of non-dilutive capital IRVINE, Calif., Feb. 02, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced it has completed enrollment of Saturn-2, the company’s second pivotal Phase 3 trial of TP-03 (lotilaner ophthalmic solution, 0.25%) for patients with Demodex blepharitis and executed a $175 million credit facility with Hercules Capital, Inc. (NYSE: HTGC) and Silicon Valley Bank (NASDAQ: SIVB). Saturn-2 Enrollment Completion “We are delighted Saturn-2 has completed enrollment with 408 patients during these challenging times, which speaks to the urgent need for an effective treatment for people living with Demodex blepharitis. We are committed to developing a solution for this disease as rapidly as possible and expect to share topline results from Saturn-2 in April, which, if positive, will be followed by a New Drug Application for TP-03 planned this year,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. Saturn-2 is a Phase 3 randomized, controlled, double-masked trial evaluating the efficacy and safety of TP-03 in patients with Demodex blepharitis. The primary endpoint is the proportion of patients achieving complete collarette cure, defined as 0 to 2 collarettes per lid and secondary endpoints are mite eradication, lid margin erythema (redness) cure and a composite of collarette and erythema cures. Saturn-2 has similar powering assumptions and design to the completed pivotal Saturn-1 trial, which successfully met the primary and all secondary endpoints. Tarsus expects topline results for the Saturn-2 trial in April and if the results are positive, data from both the Saturn-1 and Saturn-2 trials will support submission of a New Drug Application (NDA) for TP-03 for the treatment of Demodex blepharitis planned for later this year. Credit Facility with Hercules Capital and Silicon Valley Bank “We are also grateful to secure this non-dilutive $175 million credit facility, providing Tarsus with signi...