Positive Ph III results with Cubist’s Sivextro in ABSSSI

USA-based Cubist Pharmaceutical (Nasdaq: CBST) saw its share rise 3.1% to $70.80 in morning trading Friday, after the company announced that The Lancet Infectious Diseases has published online the positive results from ESTABLISH-2, a pivotal Phase III clinical trial of the investigational antibiotic Sivextro (tedizolid phosphate).

The drug is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI). The authors note that ESTABLISH-2 was the first prospectively designed clinical trial consistent with the fundamental elements outlined in the final US Food and Drug Administration  ABSSSI Guidance released in 2013.

Sivextro is a once daily oxazolidinone being developed for both intravenous (IV) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The published data are based on one of the two global Phase III clinical studies of Sivextro (ESTABLISH-1 and ESTABLISH-2), which met the primary and secondary endpoints defined by the FDA and European Medicines Agency. The clinical trials enrolled 1,333 people in the USA, Europe and other regions worldwide.