Reinach/Basel, Switzerland, 24 October 2008 – Nitec Pharma AG (“Nitec Pharma” or “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, presents 12-month safety and efficacy data for Lodotra™ in rheumatoid arthritis (RA) at the annual meeting of the American College of Rheumatology (ACR) in San Francisco (CA), USA 24 - 29 October 2008. The results show an average reduction of morning stiffness of 46% - or 84 minutes, respectively - in RA patients treated with Lodotra™ (single-pulse delayed-release (SPDR) prednisone) after 12 months.
In an initial 12 week double-blind phase, the SPDR tablet taken at bedtime was compared to immediate release (IR) prednisone, taken conventionally in the morning. The controlled double blind phase demonstrated that Lodotra™ was more effective than IR prednisone at reducing morning stiffness (mean relative reduction in the duration of morning stiffness of 22.7% vs. 0.4%, p=0.0452). A 10% difference from the baseline became apparent for the new SPDR at week two. The results also showed a pronounced reduction in serum levels of the pro-inflammatory cytokine interleukin-6 (IL-6) after 12 weeks of treatment with Lodotra™ of 28.6% compared to 0% in the conventional IR prednisone group. Following this trial, patients who had finished the three month trial started open-label treatment with Lodotra™ for a further nine months. After 12 months of treatment the mean relative reduction of morning stiffness in the SPDR prednisone group increased to 46% (p<0.001), the mean absolute change was 84 minutes. The reduction in IL-6 was maintained through the end of study at 12 months. The study was conducted in collaboration with Prof. Dr. med. Frank Buttgereit from the University Hospital Charité in Berlin (Department of Rheumatology and Clinical Immunology), Merck Serono and Nitec Pharma.
Prof. Buttgereit, Charité – Universitätsmedizin Berlin commented: “These 12-month data not only show the remarkable and clinically relevant reduction in morning stiffness, they also impressively show how Lodotra™ interferes positively with the IL-6 pathomechanism. This represents significant progress to the treatment of rheumatoid arthritis.”
Dr Anders Härfstrand, CEO of Nitec added: “Reducing morning stiffness by almost 50% will deliver great relief to people with rheumatoid arthritis. We are looking forward to bringing this important product to the market soon.”
It is well recognised that increased levels of pro-inflammatory cytokines, such as IL-6, during night-time hours are the primary cause of morning stiffness. Morning stiffness is one of the most disabling symptoms of RA and normally leads to sufferers becoming significantly immobile, unable to work and in need of home care support. Until recently there was no adequate treatment to address the circadian rhythm of morning stiffness. Lodotra™ is the only circadian cyto¬kine modulator that releases prednisone in the early morning hours and acts by reducing pro-inflammatory IL-6 levels while the patient is sleeping. Lodotra™ success¬fully completed phase 3 trials in Europe in 2006 and a dossier has been submitted for marketing approval in 15 European countries via the decentralised procedure.
The abstract “12-Month Safety and Efficacy Data of a new Night-Time Release Prednisone for the Treatment of Rheumatoid Arthritis in 288 Patients” presented at the ACR 2008 can be downloaded at www.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. Nitec’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 in Switzerland. Nitec is financed by Atlas Venture, Global Life Science Ventures, NGN Capital, TVM Capital, and a principal investing arm of Deutsche Bank AG, London. For further information about Nitec Pharma please visit www.nitecpharma.com
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