According to Arpida, the results of the second trial, called ASSIST-2, (Arpida’s Skin and Skin Structure Infection STudies), validated the results of the first phase of testing, ASSIST-1. As well as confirming that Arpida’s drug is as effective as Pfizer’s, the trial also confirmed iclaprim’s safety profile, as demonstrated in the first phase III trial, the company said.
Iclaprim targets a number of severe infections and is effective against methicillin-resistant Staphylococcus aureus (MRSA), a so-called superbug that is often contracted in hospitals. The infection is very difficult to treat and, according to Reuters, news of the antibiotic’s benefits caused Arpida’s shares to rise 27%.
Arpida said that as a result of the positive findings of the late stage trial, the company expects regulatory filing to be given before the end of 2007. Reuters also cited a spokesman for the company as saying that the drug is on target to be launched in 2008.
Dr Khalid Islam, president and CEO of Arpida, said: “We look to discuss the data with the regulatory authorities to define the path forward for the filing of a new drug application, which we expect to take place in the course of this year.”