Nitec's Phase III Results with Lodotra in RA Published in Current Issue of The Lancet
BASEL, Switzerland, January 22, 2008 - Nitec Pharma AG, a Switzerland-based specialty pharma company focused on the development and commercialization of medicines to treat chronic inflammation and pain-related diseases, today announced that the 19 Jan 2008 issue of The Lancet published the positive Phase III results of its lead product Lodotra(tm).
The results of the CAPRA-1 study, a 12-week, multicenter, randomized, double-blind trial in patients with active rheumatoid arthritis (RA) demonstrated that Nitec's new modified-release prednisone tablet, LodotraTM, significantly reduced both the duration of morning stiffness of the joints as well as levels of the proinflammatory cytokine interleukin-6 (IL-6) compared to an identical dose of standard prednisone in patients with rheumatoid arthritis.
The circadian rhythm in RA is characterized by elevated night time levels of proinflammatory cytokines such as IL-6, which cause the morning symptoms such as stiffness of the joints and pain. Morning stiffness of the joints is a characteristic symptom of RA and a major contributor to morbidity and disability of RA-patients. Glucocorticoids such as prednisone are established treatments for RA. However, only when they are administered around 2am can they effectively provide relief of the early morning symptoms. Lodotra(tm) is an oral medication that ensures rapid release of the prednisone from the tablet core about 4 hours after ingestion due to its unique delivery system. The convenient administration of Lodotra(tm) at bedtime (10pm) results in release of prednisone at about 2am. This allows inhibition of proinflammatory cytokine levels while the patient is sleeping, resulting in significantly less morning stiffness of the joints. Lodotra(tm) is the only circadian cytokine modulator that releases prednisone in the early morning hours.
Prof. Frank Buttgereit, Charité - Universitätsmedizin Berlin, commented: "The publication of these results in The Lancet demonstrates the importance of Lodotra(tm) as an innovative new approach to the treatment of rheumatoid arthritis by specifically targeting the pathophysiological rhythms of the disease. The CAPRA-1 study has confirmed that Lodotra(tm) provides a significantly better relief of morning stiffness of the joints as compared to an identical dose of prednisone. In addition, the significant reduction in IL-6 levels demonstrated in the trial shows the potential for disease modifying properties."
Dr. Achim Schäffler, co-founder and Head of R&D at Nitec Pharma said: "The publication in The Lancet of our Phase III data with Lodotra(tm) in RA should be of great interest to a broad audience, since circadian cytokine modulation with modified-release prednisone is also expected to constitute a new option for the treatment of other diseases exhibiting circadian rhythms. This could include diseases such as polymyalgia rheumatica or asthma."
Lodotra(tm) successfully completed Phase III development in Europe in 2006. Nitec has filed for marketing approval in 15 European countries via the decentralized procedure.
The article "Efficacy of modified-release versus standard
prednisone to reduce duration of morning joint stiffness in
rheumatoid arthritis (CAPRA-1): a double-blind, randomised
controlled trial" is published in The Lancet, Volume 371, No. 9608
About Nitec Pharma AG:
Nitec Pharma is a Switzerland-based specialty pharma company focused on the development and commercialization of innovative medicines to treat chronic inflammation and pain-related diseases. 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 and is headquartered in Basel/Reinach in Switzerland. 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 <http://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.
Emma Thompson Senior Consultant Financial Communications
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Posted: January 2008