Corsair Pharma completed a first-in-human phase 1 trial of the TRX-248 transdermal system, a once-daily patch that delivers an inactive treprostinil prodrug, which is converted to active treprostinil after absorption.
The single-dose study enrolled nine female volunteers who each received a single 24-hour patch per treatment period and evaluated safety and pharmacokinetics.
The company reports steady and continuous treprostinil plasma levels over 24 hours with low peak-to-trough fluctuation, pharmacokinetic profiles comparable with published subcutaneous delivery data, dose proportionality across patch sizes to facilitate titration, and acceptable safety and skin tolerability.
The company claims these data support transdermal delivery as a potentially superior alternative to current treprostinil modalities and support advancement into further clinical development.
Prostacyclin therapies generate roughly $3.3 billion in annual U.S. sales, with treprostinil representing about $2 billion, and Corsair Pharma intends to pursue a 505(b)(2) regulatory pathway for the program.
