Arpida reports progress in pivotal Phase III Trial with TLT treatment in onychomycosis
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®) formulation. The comparator is 8% ciclopirox lacquer (Penlac®) 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."
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 ® (terbinafine) and J&J’s Sporanox® (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® in EU; Penlac® in the US) and amorolfine lacquer (Galderma’s Loceryl®; 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® is the current market leader with revenues of USD 978 million in 2006.
Evolva Holding SA
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 has authorisation to commence 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.
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