Corsair Pharma Reports Phase 1 Results for TRX-248 in PAH

Key Takeaways

• After single-dose patch use, treprostinil plasma levels remained steady over 24 hours with limited peak-to-trough variation.
• Corsair reported acceptable safety and skin tolerability, and exposure increased proportionally across patch sizes.
• Corsair said the pharmacokinetic pattern was comparable to published subcutaneous treprostinil data; separately, the company said the findings support further development and that it intends to pursue a 505(b)(2) pathway.

Corsair Pharma has reported completion of its first-in-human Phase 1 trial of the once-daily TRX-248 transdermal system for pulmonary arterial hypertension. The study enrolled nine female volunteers and evaluated treprostinil after single-dose patch administration, with one application worn for 24 hours during each treatment period. Treprostinil plasma exposure was steady across that interval, with limited fluctuation between peak and trough concentrations.

The Phase 1 trial examined single-dose safety and pharmacokinetics of treprostinil delivered through the TRX-248 transdermal system in a small volunteer cohort. Each treatment period used one patch application, and the protocol focused on systemic exposure after administration rather than on clinical response measures.

Corsair describes TRX-248 as an inactive prodrug absorbed through the skin, entering circulation and rapidly converted by the liver to active treprostinil.

The pharmacokinetic profile showed continuous delivery with modest peak-to-trough variation and exposure that increased proportionally across the tested patch sizes. Safety, skin tolerability, and application-site tolerability were described as acceptable in the same early study population.