Saturn-2 Phase 3 trial to evaluate safety, efficacy of TP-03 for treatment of Demodex blepharitis

David Hutton

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OT Staff Reports

Tarsus Pharmaceuticals kicks off Saturn-2, trial, which is designed similar to Saturn-1, first pivotal trial for TP-03. Topline data from Saturn-1 is expected in July.

Tarsus Pharmaceuticals Inc. has commenced enrollment in Saturn-2, its second pivotal trial evaluating the company’s novel investigational treatment, TP-03, in patients with Demodex blepharitis.

According to the company, up to 25 million Americans may be affected by Demodex blepharitis, which is caused by an infestation of Demodex mites.

TP-03 is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent designed to target and eradicate Demodex mites.

Tarsus also recently completed full enrollment for the Saturn-1 pivotal trial, with 421 patients. Topline results of the trial are expected to be announced this July.

Demodex blepharitis is a common, yet often overlooked or misdiagnosed, ocular disease that is characterized by inflammation of the eyelid margin, redness and ocular irritation.

The disease is associated with significant clinical, functional and psychosocial burdens, with the recently presented Atlas study revealing that the majority of patients (80%) say the disease negatively affects their daily life.

Currently, there is no FDA-approved therapy for the disease.

“We are pleased to complete first patient visits in Saturn-2, our second pivotal trial of TP-03 in Demodex blepharitis,” Bobak Azamian, MD, PhD, president and CEO of Tarsus, said in a statement. “Fully enrolling the Saturn-1 trial in a timely manner underscores patients’ significant need for a safe and effective therapy, and we look forward to sharing the topline results this July.”

Azamian explained that Demodex blepharitis can have a major impact on patients as evidenced by the Atlas study of participants pre-screened for Saturn-1.

“We are committed to progressing TP-03 with the goal of potentially providing the first FDA-approved drug treatment for this disease,” Azamian said in the statement.

According to the company, the Saturn-2 trial has a similar design to Saturn-1, and is a randomly assigned, controlled, multicenter, double-masked trial studying the safety and efficacy of TP-03, lotilaner ophthalmic solution 0.25%, in adults with Demodex blepharitis.

The trial’s primary endpoint is the proportion of patients achieving collarette cure, defined as 0 to 2 eyelashes with collarettes.

Secondary endpoints include the eradication of Demodex mites and the proportion of patients achieving a cure based on a composite of collarette cure and erythema cure (eyelid redness). We expect Saturn-2 to enroll approximately 418 participants who will administer TP-03 or vehicle twice daily for 42 days.

Tarsus has completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation.

According to the companies, the positive results from these trials guided the design of the Saturn-1 and Saturn-2 pivotal trials. If the Saturn-1 and Saturn-2 trials are positive, we expect they will support the submission of a New Drug Application (NDA) to the FDA for TP-03 for the treatment of Demodex blepharitis.

TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational 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.

Tarsus has completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation.

According to the company, TP-03 is currently being evaluated in the Saturn-1 and Saturn-2 pivotal trials. If approved, TP-03 may offer treatment for millions of patients around the world with Demodex blepharitis.