Corsair Pharma Announces Successful Completion of Preclinical Program for Its Treprostinil Prodrug Transdermal System

Preparation for Phase 1 Trial Underway with Expected Start in Q2 2025

NEWARK, Calif.--(BUSINESS WIRE)--Corsair Pharma, Inc., a private biopharmaceutical company, today announced the successful completion of the preclinical program of its TRX-248 Transdermal System, a once-daily transdermal patch for the treatment of Pulmonary Arterial Hypertension (PAH). These positive results support the initiation of a Phase 1 human trial expected to begin in the second quarter of 2025.

Prostacyclins are the standard of care drug class to treat PAH. The Corsair transdermal patch is intended to provide steady and continuous blood levels of the prostacyclin drug treprostinil. The patch, applied once daily, delivers an inactive prodrug (TRX-248), which crosses the skin, enters the blood and converts rapidly to treprostinil in the liver. Corsair also believes that the patch has the potential to treat other forms of pulmonary hypertension.

“Across several studies in minipigs, the transdermal formulations of the proprietary prodrug were optimized to demonstrate steady and therapeutically meaningful blood levels of treprostinil with acceptable skin tolerability,” said Dr. Bobby Singh, President and COO, Corsair Pharma. “Combined with the positive minipig pharmacokinetic results, the Phase 1 enabling GLP toxicology studies have been successfully completed, and we look forward to the initiation of human studies in the coming months.”

“These positive preclinical results are exciting,” said George Mahaffey, CEO, Corsair Pharma. “The prostacyclin drug class sells over $3.3 billion in the U.S., with treprostinil accounting for about $2 billion annual sales. Each current delivery system for treprostinil has drawbacks for patients. A once daily TRX-248 Transdermal System that conveniently provides steady and continuous doses in humans should be a significant improvement for the management of PAH.”

About PAH and Treprostinil

Pulmonary Arterial Hypertension (PAH) is a serious, progressive, and fatal disease that causes shortness of breath, markedly reducing quality of life. In the U.S., approximately 45,000 patients are currently under treatment. Current treatments offer some symptomatic relief, but only prostanoids, such as treprostinil, have been shown to prolong life. Treprostinil is commonly used in the treatment of PAH. It exerts its pharmacological action through vasodilation and platelet aggregation and by inhibiting smooth muscle proliferation. Treprostinil is currently marketed by United Therapeutics in different dosage forms to alleviate the symptoms, maintain or improve functional class, delay disease progression, and improve quality of life in patients suffering from PAH. The prostacyclin U.S. market for PAH is approximately $3.3 billion.

About Corsair Pharma, Inc.

Corsair Pharma is developing transformative solutions to improve the therapeutic profile of medications and provide superior treatment options for patients. The company is focused on the development of novel prodrugs of treprostinil to treat patients with Pulmonary Arterial hypertension (PAH) using a once-daily transdermal patch. The company intends to pursue a 505(b)(2) regulatory pathway, which is a streamlined process to develop new versions of approved drugs. For more information, see www.corsairpharma.com.