Arpida Ltd (SWX: ARPN) presents two clinical posters on its late-stage investigational antibiotic iclaprim at the 9th annual congress for Clinical Pharmacology (Verbund Klinische Pharmakologie - VKliPha) which takes place 1-3 November in Kiel, Germany. The posters presented at the conference further expand the substantial volume of data on iclaprim that is already available. At two recent conferences in the United States, Arpida has presented a total of 24 posters on iclaprim.
Poster F-1 discusses results of Phase I studies with intravenous iclaprim in healthy volunteers. In the studies, iclaprim showed linear, predictable and gender-independent pharmacokinetic characteristics in a clinically relevant dose range. Moreover, results showed iclaprim to be safe and well-tolerated in the studies.
Poster F-25 examines the influence of ketoconazole on the pharmacokinetics and safety of intravenous iclaprim. Ketoconazole did not affect the pharmacokinetics of iclaprim. Ketoconazole is a synthetic antifungal drug used to prevent and treat skin and fungal infections, especially in immunocompromised patients. In drug-drug interaction studies, it is often used as a reference compound due to its potent inhibition of the cytochrome P450 3A4 system
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "The data presented in Kiel highlight several aspects of iclaprim’s attractive profile. In these Phase I studies iclaprim’s pharmacokinetics were shown to be predictable and unaffected by ketaconazole. Moreover, the good safety profile was confirmed. As at the previous ICAAC and IDSA conferences, we’ve encountered a lively interest in iclaprim among the congress attendees in Kiel. This again reinforces the view that there is an urgent need for new pathogen-focused antibiotics to address some of the most threatening multi-drug resistant bacteria, including MRSA. We feel iclaprim could in the future play an important role in combating life-threatening infections caused by ‘the superbug’."
The Phase I data presented in Kiel will be part of the NDA package that is expected to be submitted to the US Food and Drug Administration in the course of this year. Overall, the clinical programmes with iclaprim and the path towards the NDA filing for intravenous iclaprim in its first indication are on track. Patient enrolment into the Phase II studies with intravenous iclaprim in its second indication (HAP/VAP/HCAP) as well as into the Phase III trial with the TLT therapy in onychomycosis is expected to get underway shortly.
Arpida has a comfortable cash position, with cash and financial investments of CHF 95 million at the end of June 2007.
Arpida plans to give further updates on the progress of intravenous and oral iclaprim as well as TLT in the course of this year.
Poster F-1 discusses results of Phase I studies with intravenous iclaprim in healthy volunteers. In the studies, iclaprim showed linear, predictable and gender-independent pharmacokinetic characteristics in a clinically relevant dose range. Moreover, results showed iclaprim to be safe and well-tolerated in the studies.
Poster F-25 examines the influence of ketoconazole on the pharmacokinetics and safety of intravenous iclaprim. Ketoconazole did not affect the pharmacokinetics of iclaprim. Ketoconazole is a synthetic antifungal drug used to prevent and treat skin and fungal infections, especially in immunocompromised patients. In drug-drug interaction studies, it is often used as a reference compound due to its potent inhibition of the cytochrome P450 3A4 system
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "The data presented in Kiel highlight several aspects of iclaprim’s attractive profile. In these Phase I studies iclaprim’s pharmacokinetics were shown to be predictable and unaffected by ketaconazole. Moreover, the good safety profile was confirmed. As at the previous ICAAC and IDSA conferences, we’ve encountered a lively interest in iclaprim among the congress attendees in Kiel. This again reinforces the view that there is an urgent need for new pathogen-focused antibiotics to address some of the most threatening multi-drug resistant bacteria, including MRSA. We feel iclaprim could in the future play an important role in combating life-threatening infections caused by ‘the superbug’."
The Phase I data presented in Kiel will be part of the NDA package that is expected to be submitted to the US Food and Drug Administration in the course of this year. Overall, the clinical programmes with iclaprim and the path towards the NDA filing for intravenous iclaprim in its first indication are on track. Patient enrolment into the Phase II studies with intravenous iclaprim in its second indication (HAP/VAP/HCAP) as well as into the Phase III trial with the TLT therapy in onychomycosis is expected to get underway shortly.
Arpida has a comfortable cash position, with cash and financial investments of CHF 95 million at the end of June 2007.
Arpida plans to give further updates on the progress of intravenous and oral iclaprim as well as TLT in the course of this year.
