Arpida Reports Progress in Pivotal Phase III Trial With TLT Treatment in Onychomycosis

Arpida Reports Progress in Pivotal Phase III Trial With TLT Treatment in
Onychomycosis

REINACH, Switzerland, January 22 /PRNewswire-FirstCall/ -- Arpida Ltd.
(SWX: ARPN) announced today that patient screening for enrolment into the
pivotal Phase III study with the TLT treatment in onychomycosis has been
initiated and is progressing at a very good rate.
Approximately 220 patients in total will be enrolled in this study. A
substantial number of patients had already expressed their interest to
participate well in advance of the trial.
The open label Phase III study will evaluate the efficacy, safety and
tolerability of the TLT therapy in the treatment of patients with
mild-to-moderate toenail onychomycosis. The TLT therapy consists of a
one-time laser pre-treatment, followed by daily application of a topical
terbinafine (the active substance of Lamisil(R)) formulation. The comparator
is 8% ciclopirox lacquer (Penlac(R)) applied daily to nails that have not
undergone a prior laser pre-treatment. The treatment duration will be 48
weeks in both arms.
The primary efficacy endpoint is complete cure, which is defined as 100%
clear nails, negative fungal culture results and negative KOH microscopy.
Arpida aims to demonstrate superiority of the TLT therapy over the
comparator. Secondary endpoints include time to complete cure as well as
safety and tolerability of the TLT treatment.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are
very pleased with the high level of interest displayed by patients for
enrolment in this study and we expect a rapid progression of the TLT
treatment along its development path. The TLT therapy as a targeted approach
could offer significant advantages by providing effective treatment while at
the same time avoiding systemic exposure and bypassing the potential side
effects of oral therapies. We are on track to complete this trial by early
2009."
About onychomycosis
Onychomycosis (OM) is a fungal infection affecting mainly toenails and,
to a lesser extent fingernails. It can cause pain, discomfort, and
disfigurement and may produce serious physical and occupational limitations.
It is one of the most common dermatological diseases, affecting an estimated
30 million people in the USA alone while prevalence is steadily increasing
for various reasons, e.g. the aging of the population, diabetes etc.
Oral therapies that are effective for treating OM include Novartis's
Lamisil (R) (terbinafine) and J&J's Sporanox(R) (itraconazole). However,
patients are reluctant to adopt this systemic modality for an essentially
superficial disease particularly in view of lengthy treatment times and
concerns regarding potential toxicity and side effects.
Approved topical treatments for OM include ciclopirox lacquer
(Sanofi-Aventis's Batrafen(R) in EU; Penlac(R) in the US) and amorolfine
lacquer (Galderma's Loceryl(R); EU), however, both drugs show low efficacy
primarily due to the poor bioavailability in the nail bed. A safe and
effective topical treatment would be expected to gain a significant market
share as it would satisfy a medical need coupled with a strong patient demand.
Total revenues in this indication are ca. USD 2 billion per year and are
forecast to grow based on the increasing prevalence of OM. Moreover, due to a
lack of effective topical treatments and issues inherent to long term use of
oral treatments, a large proportion of patients remain untreated and
consequently the addressable potential market is much larger. Novartis's
Lamisil(R) is the current market leader with revenues of USD 978 million in
2006.
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities in Reinach, 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 in an NDA-filing process and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent
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. The NDA-filing process is ongoing and expected to be completed by
the end of February 2008.
In December 2007, Arpida announced the enrolment and dosing of the first
patients in a Phase II clinical study with intravenous iclaprim in the
treatment of patients with hospital-acquired pneumonia (HAP),
ventilator-associated pneumonia (VAP) or healthcare associated pneumonia
(HCAP).
In January 2008, the US FDA granted authorisation to progress oral
iclaprim into a Phase II 'intravenous-to-oral' switch trial. 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 in 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 contacts:

Dr Khalid Islam,
President and CEO,
Tel: +41-61-417-96-60

Harry Welten, MBA,
CFO and Senior Vice President,
Tel: +41-61-417-96-65

Paul Verbraeken,
Head of Corporate Communications,
Tel: +41-61-417-96-83

SOURCE Arpida Ltd

Arpida contacts: Dr Khalid Islam, President and CEO, Tel: +41-61-417-96-60;
Harry Welten, MBA, CFO and Senior Vice President, Tel: +41-61-417-96-65; Paul
Verbraeken, Head of Corporate Communications, Tel: +41-61-417-96-83