Arpida Reports Progress in Trial With TLT Treatment In Onychomycosis
Patient screening for enrolment into Arpida's 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."
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.