Basel, Switzerland, 12 June 2008 – Nitec Pharma AG (“Nitec”), a Switzerland-based specialty pharmaceutical company focused on the development and commercialisation of innovative medicines and effective treatment solutions for chronic inflammation and pain-related diseases, will today present 12 month treatment data on LodotraTM in rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology (EULAR) in Paris.
Patients who completed the 12 week, randomised, double-blind phase of the circadian administration of prednisone in RA study (CAPRA-1) could elect for continued treatment with modified release (MR) prednisone for an additional 9 months. The study was open-label, non-randomised treatment with LodotraTM.
The controlled double-blind phase had demonstrated that Lodotra™ was more effective than immediate release prednisone at reducing morning stiffness[1]. Compared to immediate release prednisone, after 3 months the study population showed a significant reduction in the duration of their morning stiffness of the joints of 22.7% versus 0.4% (p=0.0452) and a statistically significant reduction in serum levels of the pro-inflammatory cytokine IL-6 after 3 months of treatment with LodotraTM.
Subsequently, 249 patients who had completed the 3 month trial continued with open-label treatment with LodotraTM for a further 9 months. After 6 months of treatment with LodotraTM the reduction of morning stiffness amounted to 54% (103 minutes) compared to baseline. This effect was sustained until the end of the 12 month treatment period (mean reduction of 44.9%, 88 minutes). The reduction of IL-6 levels after treatment with LodotraTM was also sustained throughout the treatment period and was 45% (median) after 12 months. 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 Charité – Universitätsmedizin Berlin (Department of Rheumatology and Clinical Immunology), Merck KGaA and Nitec and follow-up results were first presented at the annual meeting of the American College of Rheumatology (ACR) in November 2007. The results of the 3 month phase III double-blind controlled trial were published in The Lancet in January 2008 (The Lancet 2008; 371: 205-214).
Dr Anders Härfstrand, CEO of Nitec: “We are proud to present long-term data on LodotraTM at the EULAR congress today. Morning stiffness is one of the debilitating symptoms of RA and reducing this by approximately 50% delivers great relief and benefit to RA patients. We look forward to bringing LodotraTM to the market.”
Nitec is awaiting marketing approval of LodotraTM in 15 European countries via the decentralised procedure.
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[1] Buttgereit et al. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomized controlled trial. The Lancet 2008; 371: 205-214
Further Information:
Dr. Anders Härfstrand
CEO
Nitec Pharma AG
Tel: +41 61 715 20 46
Mobile: +41 79 83493 20
E-mail: anders.harfstrand@nitecpharma.com
Achim Schäffler PhD
EVP R&D
Tel: +49 621 438502-12
Mobile: +49 151 174 33001
E-mail: achim.schaeffler@nitecpharma.com
About Nitec Pharma AG:
Nitec Pharma is a Switzerland-based specialty pharmaceutical company focused on the development and commercialisation of innovative medicines and effective treatment solutions for chronic inflammation and pain-related diseases. The Company’s most advanced product is Lodotra™, 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 and is headquartered in Reinach, Basel-Landschaft in Switzerland. The Company is financed by Atlas Venture, Global Life Science Ventures and NGN Capital. For further information about Nitec 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.
