PERSIST, a Phase 2 clinical study with the oral formulation of levosimendan in the continued treatment of about 300 patients with severe chronic heart failure, has been completed in the pharmaceutical research of Orion Corporation, and results are reported as anticipated in the Interim Report 1-3/2006. The study results are not sufficient for starting Phase 3 clinical trials.
In the pharmaceutical research process, Phase 2 clinical trials are the first stage where new investigational compounds are given to patients, although to a limited population, with a purpose to find sufficient evidence for determining the so-called proof-of-concept, i.e., whether the compound has the prerequisites for progressing to the large and expensive Phase 3 trials. The purpose of the PERSIST study was to show whether the orally administered formulation of levosimendan has the qualifications for being taken further to Phase 3 trials in the treatment of severe chronic heart failure. The patients who were eligible to the study had to meet the criteria of having symptoms of severe chronic heart failure despite traditional treatment. They were studied in three groups, two of which were treated with different doses of levosimendan while one of the groups received standard medication. The primary endpoints of the study included an assessment of symptoms, the need of hospitalisation, and mortality. The results did not show clear enough significance level for the primary endpoints.
Orion points out that high uncertainty and risks are always related to pharmaceutical research. This is why it is justifiable to follow a deliberate and low-profile policy in communications concerning the early phases of the research portfolio. Accordingly, Orion will continue to follow its main policy of not issuing separate releases on the results of Phase 2 clinical trials or earlier research phases. When relevant, the company will communicate the progress of such projects in the context of its regular financial reporting.
Jukka Viinanen Olli Huotari
President and CEO General Counsel
Orionintie 1A, 02200 Espoo