Laguna Pharmaceuticals has initiated a phase 3 clinical trial for its lead therapeutic candidate, vanoxerine, for treatment of atrial fibrillation and atrial flutter.
The study, known as RESTORE SR, will enrol 600 patients at trial sites in the USA and other countries and will evaluate vanoxerine at a 400mg 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 with direct current 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 direct current cardioversion, an aggressive shock therapy that requires anesthesia and is resource-intensive and unpleasant for patients,” says Howard Dittrich, 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, adds, “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 US$30m Series B financing in February 2015. Proceeds from this financing are being utilised for the late stage clinical development and commercialisation preparation for vanoxerine in atrial fibrillation and atrial flutter patients.