Lodotra Shows a Sustained Reduction of Morning Stiffness in Patients with Rheumatoid Arthritis Treated with Lodotra for 12 Months
The open-label follow-up phase lasted nine months and was the continuation of a 3 month Phase III double blind controlled trial. The controlled double blind phase had demonstrated that Lodotra(TM) was more effective than immediate release prednisone at reducing morning stiffness. Following this trial, 249 patients who had finished the 3 months trial started open-label treatment with Lodotra(TM) for a further 9 months. Patients recorded the duration of their morning stiffness for the entire treatment period of 12 months. Compared to immediate release prednisone, after 3 months the study population showed a mean relative reduction in the duration of morning stiffness of 22.7% versus 0.4% (p=0.0452, two sided). After 6 months of treatment with Lodotra(TM) the reduction of morning stiffness amounted to 55.0 % (96 minutes, pless than0.0001) compared to baseline. This effect was sustained until the end of the 12 month treatment period (mean reduction 46.1 %, 84 minutes, pless than0.0001). The results also showed a statistically significant reduction in serum levels of the pro-inflammatory cytokine IL-6 after 3 month of treatment with Lodotra(TM) compared to immediate release prednisone (p=0.0322). After 12 month of treatment with Lodotra(TM) the relative change in IL-6 between start and end of open follows up was 40.1% (median). Elevated serum levels of IL-6 during the night are thought to be a contributing factor to the early morning stiffness of RA patients. The study was conducted in collaboration with Prof. Dr. med. Frank Buttgereit from the University Hospital Charite in Berlin (Department of Rheumatology and Clinical Immunology), Merck KGaA and Nitec Pharma.
Prof. Buttgereit commented on this result: "The clear results of both a sustained reduction of morning stiffness as well as significant lower IL6 levels data in this 12 month study show the benefits of the night-time release formulation of Lodotra. This therapeutic approach enhances the quality of life of patients by reducing the cumbersome morning stiffness, a symptom of the disease patients with rheumatoid arthritis are severely suffering from."
Dr Anders Harfstrand, CEO of Nitec added: "We are delighted to have such positive 12 month results confirming the results of the double-blind period of the phase III trial. Reducing morning stiffness by about 50% will deliver tangible benefit to people with rheumatoid arthritis."
The early morning symptoms of RA, such as morning stiffness are thought to be caused by a preceding peak in the levels of proinflammatory cytokines such as interleukin-6 (IL-6). Morning stiffness is one of the most unpleasant and debilitating symptoms of RA. Until recently there was no adequate treatment to address the circadian rhythm of morning stiffness, since administration of glucocorticosteroids in the early hours of the morning during the night is not a practical alternative. Lodotra(TM) is the only circadian cytokine modulator that releases prednisone in the early morning hours and this allows inhibition of pro inflammatory IL-6 levels while the patient is sleeping. Lodotra success-fully completed Phase III trials in Europe in 2006 and a dossier has been submitted for marketing approval in 15 European countries using the decentralized procedure.
About Nitec Pharma AG:
Nitec Pharma is an emerging specialty pharma company focused in the development and commercialization of innovative medicines for the treatment of chronic inflammatory diseases and pain. Nitec is headquartered in Basel/Reinach, Switzerland, with a subsidiary in Mannheim, Germany. The Company's most advanced product is Lodotra(TM), a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004 as a spin-out of Merck KGaA. The Company is financed by Atlas Venture, Global Life Science Ventures and NGN Capital. For further information about Nitec Pharma please visit www.nitecpharma.com
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.
Contact
Nitec Pharma AG
Dr. Anders Härfstrand,
CEO, +41 61 715 20 46
Mobile: +41 79 83493 20
anders.harfstrand@nitecpharma.com
or
Achim Schäffler PhD,
Managing Director, +49 621 438502-12
Mobile: +49 151 174 33001
achim.schaeffler@nitecpharma.com
Posted: November 2007
