Tarsus completes enrollment in Saturn-2 Phase 3 trial of TP-03 for patients with Demodex blepharitis

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The company is expecting topline data in April from Saturn-2, the second Phase 3 pivotal trial of TP-03, with NDA submission on track for this year.

Tarsus Pharmaceuticals Inc. 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.

According to the company, it also has executed a $175 million credit facility with Hercules Capital Inc. and Silicon Valley Bank.

Saturn-2 Enrollment Completion
In a news release, Bobak Azamian, MD, PhD, president and CEO of Tarsus, noted that 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,” Azamian said in a statement.

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.

According to the company, 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
Azamian said the company secured a non-dilutive $175 million credit facility, providing Tarsus with “financial flexibility to drive our business growth as we continue to pioneer the treatment landscape for patients with Demodex blepharitis and other important diseases.”

“With these developments, we are on track to advance and expand our pipeline, including delivering pivotal Phase 3 data from Saturn-2, submitting the TP-03 NDA for Demodex blepharitis, and if approved, be well-positioned for our expected commercial launch of TP-03 next year,” Azamian said in the statement.

According to the company, availability under this credit facility potentially extends cash runway well into the anticipated commercialization of TP-03.

Armentum Partners served as Tarsus’ financial advisor in connection with this credit facility.