Fady I. Malik, SVP, Research and Development
Thank you Robert. As Robert mentioned the lead drug candidate license done in this collaboration at CK107. Our next generation fast skeletal troponin activator. Over the last 18 months Cytokinetics, conducted a development program under Astellas’ sponsorship which evaluated CK107 and helped the volunteers 5 phase 1 clinical trials. They were trialing at safety tolerability in the pharma kinetics during single and multiple dosing. The pharma kinetics of different oral forms of CK107 were also characterized to inform formulation development. In addition, we also demonstrated the translation of the mechanism of action into CK107 into human characterizing its pharmaceutical dynamic and pharmaceutical kinetic relationship. Altogether the studies have set the stage for the further study of CK107 in phase 2 clinical trials. Colleagues at Cytokinetics and Astellas were collaboratively to oversee and review the results of these trials as well as other joint development activities to agreeing on future development plans for CK107.
Under our expanded collaboration together with Astellas, we have agreed to pursue the initial phase 2 development of CK107 in SMA. The No. 1 genetic cause of death in infant. SMA effects approximately one in 10000 babies which translates to over 45000 people who live with SMA in the United States alone. SMA manifests in progressive muscle weakness and various degrees of severity resulting in reportorial mobility in permanent. There are four types of SMA. Named for the time of initial on set of muscle weakness and related symptoms. Type 1, Infantile, type 2, Intermediate, type 3 Juvenile and type 4 Adult Offset. Life expectancies and disease severity varies by SMA type. Type 1 patients are the worst prognosis and life expectancy is often less than two years from birth. Well type 4 may have a normal life span but with gradually progressive weakness and the approximate muscle extremities resulting in mobility issues.
No treatment options exist for these patients resulting a high on net need for new therapeutic options to address symptoms and modify disease progression. The initial planned SMA phase 2 trial that we will conduct will focus on patients who are albescents or adults, living with this disease. That may benefit from a treatment then improves muscle function and delays muscle fatigue. We will provide more detail regarding our plan phase 2 clinical trial design as we approach study initiation later this year. On a research front in this collaboration Cytokinetics has combined its foremost position in the discovery and the mechanistic biology of small molecule activators a skeletal muscle contractility with Astellas’ advanced pharmaceutical discovery and development capabilities.
Companies that worked together to identify, characterize and optimize fast skeletal troponin activators and other potential novel mechanism. Skeletal muscle activators. Joint research program is designed to leverage the two company’s cutting edge capabilities and discovery technologies, medicinal chemistry, analytical chemistry, structural biology, computational chemistry and pharmacology of muscle contractility. Under our expanded collaboration we have extended the joint research program to continue until the end of 2016. We are pleased to work with Astellas and its promising novelery of research and development. Nature of our collaboration allows us to pursue the breath of potential therapeutic opportunities for activators of skeletal muscle contractility. Together we share common objective which is the pioneer development of this area across the wider ray of potential disease indications and conditions. I will now turn the call over to Sharon to discuss the financial applications related to our expanded collaboration.
