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Munich, Germany – 15 November 2005. IDEA AG presents today the results of its first European phase III study with IDEA-033, a targeted analgesic, at the late breaking news session of the annual scientific meeting of the American College of Rheumatology, taking place in San Diego, USA.
The six-week, multi-center, randomized, double-blind, double-dummy, parallel-group study was conducted in 397 subjects, and compared the safety and efficacy of ~100 mg of ketoprofen in Transfersome® gel (IDEA-033) applied epicutaneously, twice daily (b.i.d.) with that of celecoxib (100 mg orally b.i.d.) and placebo in treating the signs and symptoms of osteoarthritis of the knee. The study was co-sponsored by IDEA AG, and McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, USA, a subsidiary of Johnson & Johnson.
Three co-primary endpoints were defined a priori. In the intent-to-treat (ITT) analysis, for the WOMAC pain subscale, both IDEA-033 (p = 0.0041) and celecoxib (p 0.0004) showed a statistically significant improvement in the least squares (LS) mean change from baseline at week 6 versus placebo. For the WOMAC physical function subscale, celecoxib showed a significant (p = 0.010) improvement in the LS mean change from baseline at week 6 versus placebo; the improvement for IDEA-033 versus placebo approached statistical significance (p =0.077). For Patient Global Assessment, both IDEA-033 (p = 0.0015) and celecoxib (p = 0.0145) showed a statistically significantly higher response to therapy at week 6 for the LS mean values versus placebo. Analysis of the primary efficacy endpoints by study week demonstrated that the therapeutic response to both IDEA-033 and celecoxib progressively improved over the six-week study period. The results of the per-protocol analysis were generally consistent with the ITT analysis, but the improvement after 6 weeks treatment with IDEA-033 was significantly (p = 0.0118) greater than with placebo also for the WOMAC physical function subscale.
IDEA-033 was well tolerated. Overall, 53.6% of subjects treated with IDEA-033, 50.0% of subjects treated with celecoxib, and 48.8% of subjects treated with placebo reported adverse events, the differences not being statistically significant (p = 0.7116).
Dr. Matthias Rother, Executive Head of R&D at IDEA, commented: "We are very delighted by the positive phase III data of our lead targeted analgesic product for the treatment of osteoarthritis, a very prevalent and disabling disease. Our data indicate efficacy similar to that of a leading oral NSAID, whilst having much lower systemic drug exposure. The end-points used follow the recommendations and guidance published by the US Food and Drug Administration (FDA) as well as the European health regulatory authorities. To our knowledge IDEA's trial is the first study with a product applied on the skin that meets these pre-defined endpoints for the comparison of a targeted NSAID, applied epicutaneously, to placebo as well as to an oral NSAID."
For further information, please contact:
IDEA AG
Matthias Rother MD PhD, Executive Head of R&D
Evert Küppers MSc., MBA, VP Business Development
Tel.: +49 89 32 46 33 0
Notes to editors:
About IDEA AG
IDEA is a privately held biopharmaceutical company with headquarters in Munich, Germany. The company develops and commercialises targeted therapeutics applied non-invasively through the skin, or nose. The products are based on a proprietary carrier, Transfersome®, and are typically applied on skin, through which they are driven by the naturally occurring moisture gradient to achieve high drug concentration at, and if desired below, the site of application. This diminishes local or systemic adverse side effects and often increases drug potency. In total, 55 patents from 8 patent families protect the core technology to date.
The Company's leading products are in the area of dermatology and pain. IDEA-033, with excellent market potential, has completed a Ph III (EU) / Ph II (US) clinical study. IDEA's further pipeline includes one therapeutic in Ph II, one entering Ph II and three earlier stage development products. In-house capabilities range from formulation and small-scale (GMP) manufacturing work to clinical testing.
Additional information can be found on IDEA's website at www.idea-ag.de
Background information:
Osteoarthritis
Osteoarthritis (OA), the clinical syndrome of joint pain and dysfunction caused by joint degeneration, affects more people than any other joint disease. It is one of the leading causes of disability, as by the age of 65 an estimated 85% of the population will have some degree of OA. Oral non-steroidal anti-inflammatory drugs (NSAIDs) are most commonly used to treat OA. Although effective, they cause serious adverse side effects, including gastrointestinal and cardiac problems or kidney and liver abnormalities. Topical NSAIDs, which are marketed in the EU but have never been approved to date in the US, may be seen as generally safer, but were shown to be ineffective for the treatment of chronic pain beyond a two-week treatment duration (Lin et al., BMJ 2004).
NSAID Market
Worldwide sales of non-steroidal anti-inflammatory drugs (NSAIDs) are estimated to be €14 billion. Globally, approximately 30 million people take oral NSAIDs on a daily basis; NSAIDs are also the golden standard for treating the majority of arthritic diseases and chronic pain. The main disadvantage is that all classical oral NSAIDs carry a risk of upper gastrointestinal (GI) side effects, with up to 30% of long-term NSAID users developing gastric ulcers, for example. Close to 20,000 osteoarthritis patients and 2,000 rheumatoid arthritis patients in the US alone die each year from GI complications associated with oral NSAID use. Newer, more selective NSAIDs (so-called COX-2 inhibitors) were developed to selectively inhibit only the COX-2 pathway, while sparing the COX-1 enzymes, which are also affected by the old NSAIDS. Until recently, COX-2 inhibitors were therefore seen by broad opinion, as a relatively safe arthritis treatment option. However, as illustrated by recent worldwide withdrawals of both Vioxx® (rofecoxib) and Bextra® (valdecoxib), COX-2 inhibitors could lead to serious adverse side effects as well, such as cardiovascular events. Consequently, the US Food and Drug Agency (FDA) has recently mandated black-box warnings on all prescribed NSAIDs and similar labelling changes for comparable over-the-counter medicines.
IDEA-033
IDEA-033 contains ketoprofen, a particularly potent, well-established non-steroidal antiinflammatory drug, in a Transfersome®-based gel. Transfersomes® are novel, ultra deformable vesicle carriers designed to deliver drugs non-invasively through the skin barrier. Furthermore, Transfersomes® can be applied to target muscles and joints below the application site without being cleared by the local cutaneous blood microcirculation. The resulting targeted drug delivery can increase product efficacy (having higher local drug concentration) and improve product safety (having lower systemic drug concentration) in comparison with existing oral and/or topical NSAID formulations. IDEA-033 is expected to become the first, truly effective, targeted analgesic on the market for treating peripheral chronic pain, such as that caused by osteoarthritis. IDEA-033 should, moreover, give the medical community an effective and safe alternative for suppressing pain associated with muscle conditions.
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