It's only completed phase I so far...
4SC SUCCESSFULLY CONCLUDES PHASE I STUDY FOR PRODUCT CANDIDATE FOR THE TREATMENT OF AUTOIMMUNE DISEASES
24 March 2005 - 4SC AG, a drug discovery and development company specialising in research and development of therapeutic agents, announced today that they have successfully concluded phase I studies for the small molecule product candidate SC12267 for treatment of autoimmune diseases such as rheumatoid arthritis and multiple sclerosis.
A safe and well tolerated dose was determined in these studies, which did not cause any relevant side effects after 14 days of once daily application of SC12267. Furthermore, the substance demonstrated a very good pharmacokinetic profile, suitable for once daily dosing.
In May 2004, 4SC AG announced a global agreement on the development and commercialisation of SC12267 and back-up compounds with a biopharmaceutical company (Serono). Both companies have now agreed that all rights for further clinical development and marketing will be returned to 4SC AG.
The clinical stipulations for beginning phase II have been fulfilled with the successful conclusion of Phase I. 4SC AG has already begun preparations for a Phase IIa study in rheumatoid arthritis.
Dr. Ulrich Dauer, CEO of 4SC AG commented: "The promising results of clinical phase I create ideal conditions to tap the enormous potential of this project for the therapy of autoimmune diseases with their high medical need. Commercially, it is a very attractive project."
SC12267 is a novel, small molecule agent from the class of DMARDs (disease modifying anti-rheumatic drug) for the therapy of autoimmune diseases such as rheumatoid arthritis or multiple sclerosis. Through highly selective inhibition of pyrimidine biosynthesis, it controls the growth of rapidly proliferating cells, especially of lymphocytes, which are important for the immune response.
SC12267 shows excellent effects in animal studies of rheumatoid arthritis and multiple sclerosis, which demonstrates a high potential of this substance for the treatment of autoimmune diseases. Further pre-clinical studies have demonstrated the good tolerability and favourable pharmacokinetic properties of this immunomodulator. These results could be confirmed in two placebo-controlled clinical phase I studies, with escalating single doses and multiple doses applied for 14 days in volunteers. SC12267 is orally bio-available and demonstrates a half-life in man which allows a once daily dose in therapeutic use. The substance was tested in 90 volunteers. SC12267 did not cause liver toxicity nor diarrhoea as adverse events. Such side effects have been described for an approved anti-rheumatic drug with the same mode of action as SC12267.
In the Phase I study, a dose with good tolerability was identified. Based on the results from the animal studies conducted, a high probability of therapeutic effectiveness of this dose can be postulated.
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