Laguna Pharmaceuticals Initiates Phase 3 Study of Vanoxerine in Atrial Fibrillation and Atrial Flutter
RESTORE SR to study efficacy and safety of vanoxerine in atrial fibrillation (AF) and atrial flutter (AFL) patients, results expected in the second half of 2016
LA JOLLA, Calif., September 14, 2015 -- Laguna Pharmaceuticals announced today the initiation of a Phase 3 clinical trial for its lead therapeutic candidate, vanoxerine, for treatment of atrial fibrillation (AF) and atrial flutter (AFL).
The study, known as RESTORE SR, will enroll 600 subjects at trial sites in the U.S. and other countries and will evaluate vanoxerine at a 400 mg dose. In the Phase 2b COR-ART study, this dose was effective in restoring sinus rhythm in greater than 80% of patients, a level approaching that of the leading intervention – delivery of electrical shock to the heart in a procedure known as direct current (DC) cardioversion. RESTORE SR is similar in design to the COR-ART study, including an identical primary efficacy endpoint and inclusion of patients with structural heart disease, for whom existing therapies may be contraindicated. Laguna expects results from the study in the second half of 2016.
“Patients suffering with atrial fibrillation currently face few attractive choices in dealing with their condition, and often resort to DC cardioversion, an aggressive shock therapy that requires anesthesia and is resource-intensive and unpleasant for patients,” said Howard Dittrich, M.D., chief medical officer of Laguna. “If successful, vanoxerine has the potential to be a transformative therapy in this field by offering a safe and highly effective acute pharmaceutical treatment for patients.”
Bob Baltera, chief executive officer of Laguna, added, "Initiating this trial is a significant milestone for Laguna as we look to evaluate the full potential for vanoxerine. In a short amount of time we will be able to complete this Phase 3 study and demonstrate the benefit of vanoxerine for those patients who suffer from atrial fibrillation or flutter."
Laguna completed a $30 million Series B financing in February 2015. Proceeds from this financing are being utilized for the late stage clinical development and commercialization preparation for vanoxerine in AF and AFL patients.
Vanoxerine is a therapeutic candidate currently being evaluated in a Phase 3 clinical study for treatment of atrial fibrillation, the most common form of heart arrhythmia, and atrial flutter. These conditions are often treated through direct current cardioversion, an aggressive procedure that delivers electrical stimulation to the heart. In a Phase 2b clinical study, vanoxerine demonstrated statistically significant improvement in converting from atrial fibrillation to normal sinus rhythm – with response rates for a 400 mg dose approaching those typically achieved with direct current cardioversion. In clinical studies conducted to date, vanoxerine has demonstrated positive safety and tolerability.
About Laguna Pharmaceuticals
Laguna Pharmaceuticals is a biopharmaceutical company advancing vanoxerine for treatment of atrial fibrillation and atrial flutter. For more information, visit www.lagunarx.com.