Arpida Ltd today announced that it has submitted a Marketing Authorisation Application (MAA) for intravenous iclaprim for the treatment of complicated skin and soft tissue infections (cSSTI) to the European Medicines Agency (EMEA).
Iclaprim is an antibiotic drug candidate with potent bactericidal activity against MRSA and a range of important pathogens.
The iclaprim MAA contains data from 15 clinical studies, including two controlled, multinational, pivotal phase III trials. Patients enrolled in the phase III trials exhibited a high incidence of methicillin-resistant Staphylococcus aureus (MRSA) as causative pathogen.
In both of these independent phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint of non-inferiority as compared to linezolid. In the studies, iclaprim was well tolerated with a safety profile that compared favourably in the treatment of patients with cSSTI.
Dr Paul Hadvary, Head of Development of Arpida Ltd, said: “According to estimates of the European Centre for Disease Prevention and Control, about three million people per year catch a healthcare-associated infection in the EU and approximately 50,000 die. We strongly believe that iclaprim, if approved, could help to combat this serious and increasing assault by resistant pathogens causing serious and life-threatening hospital infections.”
In addition to the cSSTI indication, iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia, ventilator-associated pneumonia or healthcare-associated pneumonia suspected or confirmed to be due to gram-positive pathogens. This programme is currently in phase II clinical evaluation.