BASEL, Switzerland, September 24 Nitec Pharma AG todayannounced that the US Food and Drug Administration (FDA) has accepted theInvestigational New Drug (IND) application submitted by Nitec for theinitiation of clinical development for Lodotra.
Following the positive results of a European Phase III trial (CAPRA-1;Circadian Administration of Prednisone in Rheumatoid Arthritis), Nitecsubmitted a dossier for marketing authorization in Europe. The FDA'sacceptance of the IND will now allow Nitec to start clinical development ofLodotra in the USA.
A second Phase III study (CAPRA-2), currently planned to be initiated inthe second quarter of 2008 will include about 300 patients in the US and EU.
"The new Lodotra trial is highly relevant for rheumatoid arthritispatients. Lodotra reduces IL-6 levels and has great potential to improve thesigns and symptoms of RA, such as morning stiffness," commented ProfessorKenneth G. Saag of the University of Alabama at Birmingham, member of thescientific steering group in the planned Phase III trial.
Clinical trials of Lodotra have demonstrated that it is a treatment thatcan make a difference to the lives of patients with RA. Morning stiffness isa debilitating symptom of the disease with a significant negative impact onthe lives of patients with RA and Lodotra now offer clinicians an effectivepotential treatment option.
"It was always our intention to conduct the appropriate trials in the USand to further elucidate the additional benefits which Lodotra can bring toRA patients on top of the exciting results we have seen in our CAPRA-1 study.We are therefore very pleased to have been given the go-ahead from the FDA toinitiate the clinical development of Lodotra in the USA," said AndersHarfstrand, CEO of Nitec Pharma.
Lodotra is a modified-release tablet that has been developed to optimizethe efficacy of orally administered low-dose prednisone in RheumatoidArthritis (RA). Lodotra has the additional, clinically important advantage ofreducing the morning stiffness characteristic of RA, which is combined with aconvenient dosing regimen and a comparable safety profile to standardprednisone.
About Nitec Pharma AG:
Nitec Pharma is a biopharmaceutical company specialized in thedevelopment and commercialization of optimized medicines for the treatment ofchronic inflammatory diseases and pain. Nitec is headquartered in Reinach,Switzerland, with a subsidiary in Mannheim, Germany. The Company's mostadvanced product is Lodotra(R), a circadian cytokine modulator for thetreatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004as a spin-out of Merck KGaA. The Company is financed by Atlas Venture, GlobalLife Science Ventures and NGN Capital. For further information about NitecPharma please visit http://www.nitecpharma.com
This press release contains specific forward-looking statements, e.g.statements including terms like believe, assume, expect or similarexpressions. Such forward-looking statements are subject to known and unknownrisks, uncertainties and other factors which may result in a substantialdivergence between the actual results, financial situation, development orperformance of the company and those explicitly or implicitly presumed inthese statements. Against the background of these uncertainties readersshould not place undue reliance on forward-looking statements. The companyassumes no responsibility to update forward-looking statements or to adaptthem to future events or developments.
Notes for Editors:
Lodotra provides all the benefits of standard immediate release (IR)prednisone but has the additional, clinically important advantage of reducedmorning stiffness combined with a convenient dosing regimen and a comparablesafety profile.
The diurnal rhythm in RA is characterised by elevated night time lev