Laboratorios SALVAT S.A. (SALVAT) and Kwang Dong Pharmaceutical Co. Ltd (Kwang Dong) today announced the successful completion of the Phase IIb clinical trial for Tarafenacin, a new drug under development for the treatment of Overactive Bladder syndrome (OAB).
In this Phase IIb trial, Tarafenacin, at doses of 0.2 mg and 0.4 mg, proved superior to placebo after 4 weeks in reducing the number of micturitions per day, the main endpoint of the study. Promising results were obtained in secondary endpoints (volume voided per micturition, urinary urgency episodes and quality of life related endpoints).Tarafenacin showed the expected dose-efficacy response and confirmed the excellent safety profile described in previous trials due to its selectivity. Remarkable data on the low incidence of constipation was also obtained.
The clinical trial included 234 patients with OAB and was conducted in 8 sites in South Korea: Asan Medical Center, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Seoul St. Mary's Hospital, Cheil Medical Center, Ajou Medical Center and Pusan National University Hospital.
These encouraging results allow SALVAT and Kwang Dong to move forward to Phase III in patients suffering this debilitating disease.
Tarafenacin is the most potent and selective M3 vs. M2 yet developed. In earlier Phase I clinical trials, Tarafenacin proved to be safe both in healthy young and elderly volunteers. In the Phase II clinical trials in OAB patients, Tarafenacin showed an excellent efficacy and tolerability profile. This profile is expected to give Tarafenacin improved efficacy and tolerability, increasing the benefit/risk ratio compared to current treatments.
Overactive Bladder syndrome is characterized by urinary urgency, with or without urgency-associated urinary incontinence and often associated with urinary frequency and nocturia. The prevalence of OAB ranges from 10 to 17% in adult population, depending on sex and age. The OAB market has been growing rapidly for the past few years.
SALVAT entered into a licensing and co-development agreement with Kwang Dong for South Korea in November 2010. After the completion of this Phase IIb clinical trial, SALVAT has initiated the design of the Phase III and discussions with potential regional partners to continue the development of Tarafenacin at a global scale.
Based in Barcelona, Spain, SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, SALVAT has presence in over 60 countries worldwide in collaboration with well-reputed pharmaceutical partners. SALVAT is working to strengthen its international presence by licensing its own developments. SALVAT is now developing a new combination of an antibiotic and steroid for the treatment of Ear Infections. The new combination is under phase III clinical trials in USA. More information at www.salvatbiotech.com
About KWANG DONG
Kwang Dong is one of the major pharmaceutical companies in Korea and is highly experienced in introducing and developing late-stage drugs for the Korean market. Kwang Dong’s main focus lies in the development of drugs within oncology and QOL. Kwang Dong expects that Tarafenacin will reinforce the company’s presence in urology together with its existing products and pipelines in development. More information at www.ekdp.com
Cristina Viayna - Business Development