Cardiome Pharma Corp. and partner Fujisawa Healthcare Inc. are starting a third Phase III trial of RSD1235 for the acute treatment of atrial fibrillation.
Fujisawa, of Deerfield, Ill., will conduct the trial as per the $68 million development and marketing agreement the firms signed in October. The deal gave North American rights to the intravenous formulation of RSD1235 to Fujisawa, which also agreed to pay 75 percent of development costs. Cardiome retains rights elsewhere for the intravenous version, and global rights for the oral version of the product. (See BioWorld Today, Oct. 17, 2003.)
RSD1235, a candidate discovered by Cardiome, selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation (AF), a condition in which the atria of the heart beat rapidly and erratically.
RSD1235 continues to be studied in two ongoing Phase III trials, Don Graham, director of corporate communications for Vancouver, British Columbia-based Cardiome, told BioWorld Today.
Collectively, the trials, known as ACT (Atrial arrhythmia Conversion Trial) 1, 2 and 3, will enroll about 1,000 people.
ACT 3, designed to include about 350 patients, will measure the safety and efficacy of RSD1235 in recent onset atrial arrhythmia patients, Cardiome said. The placebo-controlled study is being conducted in more than 50 centers throughout the world.
Meanwhile, ACT 1, a 400- to 420-patient study initiated last August, is a placebo-controlled study being conducted at 45 centers in the U.S., Canada and Scandinavia.
Graham said ACT 1 and 3 are similar, while ACT 2, a 200- to 220-patient study, is designed evaluate the efficacy and safety of the candidate in patients who have developed transient atrial fibrillation following cardiac surgery.
ACT 2, also a placebo-controlled trial, is being conducted at 25 centers in the U.S., Canada and Europe. ACT 2 and ACT 3 should be finished next year. Data from ACT 1 is expected to be ready by the end of the year, Graham said.
Nevertheless, Graham would not speculate as to when the company would file a new drug application. However, he did say the firms likely will seek U.S. regulatory clearance first.
Data from a Phase II study of 56 new-onset patients demonstrated that RSD1235 terminated AF in 61 percent of patients vs. 5 percent with placebo within 30 minutes of the end of infusion (p=0.0003).
Cardiome expects to initiate clinical studies for the chronic oral therapy of AF by the end of the year.
Outside of RSD1235, Cardiome hopes to win FDA approval of oxypurinol for gout. In late June, the FDA issued an approvable letter on the candidate, saying it wanted additional clinical and manufacturing data before it could clear oxypurinol for marketing. (See BioWorld Today, June 25, 2003.)
Oxypurinol, a xanthine oxidase inhibitor, is in a Phase II trial for congestive heart failure.
Cardiome's stock (NASDAQ:CRME) Wednesday closed at $5.60, up 10 cents.