Arpida Ltd (SWX: ARPN) announced the results of a Phase I trial
investigating the possible interaction between intravenous iclaprim and
warfarin. Warfarin is widely used for the prophylaxis of thrombosis and
embolism and its dosing needs to be well-controlled.The drug-drug
interaction study comprised 24 healthy volunteers and was performed in
Germany. Dosing of warfarin with and without pre- and co-administration of
iclaprim (1.6 mg/kg infused over 60 minutes) was investigated.
Administration of intravenous iclaprim at this supra-therapeutic dose
was assessed to be safe for clinical applications. It had no significant
effect on the pharmakonetics and pharmacodynamics of warfarin. Moreover,
the trial results again confirm the good safety and tolerability profile of
iclaprim.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "The
results of this Phase I study are very positive, showing that iclaprim has
no significant effect on the pharmacokinetics of warfarin, which is widely
used in the targeted patient population. The results expand the experience
gathered in an earlier Phase I study in which the interaction between
ketaconazole and iclaprim was investigated. In summary, iclaprim's
drug-drug interaction profile looks favourable. This is of great importance
as iclaprim is expected to be administered to patients with significant
co-morbidities and receiving several other medications. These Phase I data
add substantial weight to the NDA package that we intend to file shortly
with the U.S. Food and Drug Administration for intravenous iclaprim in its
first indication: complicated Skin and Skins Structure Infections (cSSSI)."
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities near Basel, Switzerland and in the USA. It focuses on the
discovery and development of novel drugs that seek to overcome the growing
problem of microbial resistance. The most advanced compounds include an
antibacterial close to NDA-filing and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent,
pathogen-focused, late-stage antibiotic that targets severe infections
requiring hospital treatment, including those caused by
methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug
Administration has granted fast track status to intravenous iclaprim. In
March 2007, Arpida completed patient enrolment in the second pivotal Phase
III trial in complicated skin and skin structure infections. The top-line
data of the second trial were reported in July 2007. An NDA filing is
expected to take place in the second half of 2007.
In June 2007, Arpida announced that it has received approval from the
US FDA to initiate Phase II trials with intravenous iclaprim in the
treatment of patients with hospital-acquired pneumonia (HAP),
ventilator-associated pneumonia (VAP) or healthcare associated pneumonia
(HCAP).
An oral formulation of iclaprim has successfully completed three Phase
I trials: an ADME study (absorption, distribution, metabolism and
excretion) with radiolabelled compound, a Phase I bioavailability trial
with a solution and one with a capsule formulation. Iclaprim could be
offered not only as an intravenous therapy for hospital use in acute
situations, but also as an oral formulation, allowing early patient
discharge followed by outpatient treatment. This switch should be a
valuable instrument in reducing healthcare costs and enhancing patient
comfort.
Arpida's fourth most advanced antibiotic programme, AR-709, targets
upper and lower respiratory tract infections acquired in the community
setting. AR- 709 exhibited potent activity against a large panel of
pneumococcal clinical isolates including those resistant to currently used
drugs. Promising results of "first-in-man" studies with AR-709 were
published in March 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept.
AR-2474 has been shown to be highly effective in eradicating pathogens in
preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative
antifungal therapy (TLT) which is about to enter Phase III clinical trials
in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and
additional discovery programmes derived from its own discovery platform at
various research stages.
This press release contains specific forward-looking statements, e.g.
statements including terms like believe, assume, expect or similar
expressions. Such forward-looking statements are subject to known and
unknown risks, uncertainties and other factors which may result in a
substantial divergence between the actual results, financial situation,
development or performance of the company and those explicitly or
implicitly presumed in these statements. Against the background of these
uncertainties readers should not place undue reliance on forward-looking
statements. The company assumes no responsibility to update forward-looking
statements or to adapt them to future events or developments.
Arpida Ltd.
arpida.ch
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