Arpida Ltd (SWX: ARPN) presented several posters containing clinical data on its late-stage investigational antibiotic iclaprim at the 45th Annual Meeting of the Infectious Diseases Society of America (IDSA). IDSA is a major conference where infectious disease specialists and clinical researchers gather to discuss the latest developments in the field of infectious diseases.
Arpida supported a symposium entitled: "Emerging Treatments for Resistant Bacterial Infections - The Concept of Pathogen-focused Therapy". The faculty consisted of key opinion leaders such as Louis Rice, John Bartlett, Donald Craven, Robert Moellering, Dennis Stevens and George Eliopoulos. Arpida also had a booth at the IDSA meeting which was very well visited and Arpida’s compound met with lively interest from the conference attendees. Arpida presented five posters on clinical aspects of iclaprim, following on the heels of the 19 presentations at ICAAC in late September 2007.
Poster 1079 described iclaprim’s efficacy in the first of two pivotal Phase III trials in complicated skin and skin structure infections (ASSIST-1). The results showed that iclaprim exhibited high clinical cure rates and achieved its pre-specified primary endpoint of non-inferiority to linezolid in this study.
Posters 432 and 1083 discussed the effect of iclaprim on the QT interval in healthy volunteers (Phase I) and in patients (Phase III; ASSIST-1), respectively. Both studies concluded that the QT prolongation is transient and rapidly reversible. In patients the QT changes observed after one day and four days of dosing with iclaprim were 6.3 ms and 3.8 ms, respectively. After correcting for comparator control a 4-5 ms QT change from pre-treatment values was observed in ASSIST-1.
Poster 1104 gave an overview of iclaprim’s safety profile in the ASSIST-1 trial. There were no treatment-related serious adverse events in this study. None of the mild-to-moderate adverse events that were possibly/probably related to treatment occurred in more than 3% of the iclaprim group.
Poster 448 summarised the results of a Phase I study investigating the pharmacokinetics of iclaprim in special populations with varying degrees of renal and hepatic impairment and obesity. The results of the study showed that iclaprim was safe and well-tolerated in all these special populations. Furthermore, the predictable pharmacokinetics observed in these populations would suggest that monitoring may not be required.
Dr Khalid Islam, President and CEO of Arpida Ltd commented: "The high level of interest at the IDSA meeting further confirms the positive reception we’ve seen at ICAAC. The clinical data that we presented at this conference shed additional light on both efficacy and safety of iclaprim. Overall, these data and their reception at the two recent conferences highlight iclaprim’s potential to become a potent novel drug with promising pathogen-focused efficacy against some of the most threatening multi-drug resistant bacteria."
Arpida supported a symposium entitled: "Emerging Treatments for Resistant Bacterial Infections - The Concept of Pathogen-focused Therapy". The faculty consisted of key opinion leaders such as Louis Rice, John Bartlett, Donald Craven, Robert Moellering, Dennis Stevens and George Eliopoulos. Arpida also had a booth at the IDSA meeting which was very well visited and Arpida’s compound met with lively interest from the conference attendees. Arpida presented five posters on clinical aspects of iclaprim, following on the heels of the 19 presentations at ICAAC in late September 2007.
Poster 1079 described iclaprim’s efficacy in the first of two pivotal Phase III trials in complicated skin and skin structure infections (ASSIST-1). The results showed that iclaprim exhibited high clinical cure rates and achieved its pre-specified primary endpoint of non-inferiority to linezolid in this study.
Posters 432 and 1083 discussed the effect of iclaprim on the QT interval in healthy volunteers (Phase I) and in patients (Phase III; ASSIST-1), respectively. Both studies concluded that the QT prolongation is transient and rapidly reversible. In patients the QT changes observed after one day and four days of dosing with iclaprim were 6.3 ms and 3.8 ms, respectively. After correcting for comparator control a 4-5 ms QT change from pre-treatment values was observed in ASSIST-1.
Poster 1104 gave an overview of iclaprim’s safety profile in the ASSIST-1 trial. There were no treatment-related serious adverse events in this study. None of the mild-to-moderate adverse events that were possibly/probably related to treatment occurred in more than 3% of the iclaprim group.
Poster 448 summarised the results of a Phase I study investigating the pharmacokinetics of iclaprim in special populations with varying degrees of renal and hepatic impairment and obesity. The results of the study showed that iclaprim was safe and well-tolerated in all these special populations. Furthermore, the predictable pharmacokinetics observed in these populations would suggest that monitoring may not be required.
Dr Khalid Islam, President and CEO of Arpida Ltd commented: "The high level of interest at the IDSA meeting further confirms the positive reception we’ve seen at ICAAC. The clinical data that we presented at this conference shed additional light on both efficacy and safety of iclaprim. Overall, these data and their reception at the two recent conferences highlight iclaprim’s potential to become a potent novel drug with promising pathogen-focused efficacy against some of the most threatening multi-drug resistant bacteria."
