Speedel Starts Human Testing With SPP 301, Its Endothelin A Receptor Antagonist
BASEL, Switzerland, and BRIDGEWATER, N.J., July 6 /PRNewswire/ -- The Speedel Group, a cardiovascular and metabolic drug development company based in Basel, Switzerland, announced today the initiation of Phase I testing of SPP 301, an optimized endothelin A receptor antagonist. This first phase I study is based on a randomized, double blind, placebo-controlled design. Ascending oral doses of SPP 301 are to be given to healthy male volunteers and tolerability and drug levels are assessed.
``This first study with SPP 301 in man becomes possible only a few months after an exclusive option agreement was signed with Roche for this interesting development candidate,'' states Thierry Briand, M.D., Speedel's Project Director for SPP 301. ``Speedel has been able to complete within a few months all necessary pre-clinical activities, elaborate comprehensive documentation, establish the Phase I protocol and obtain the Ethical Review Committee approval, demonstrating again its fast-track development capabilities. Hence, we can start the first human study swiftly, and explore stepwise the potential of this compound in man.''
Alice Huxley, President and CEO commented: ``Initiation of the first human study with SPP 301 is a significant event for Speedel. It means that Speedel now has two compounds in active clinical and technical development: the oral renin inhibitor SPP 100, licensed from Novartis Pharma AG and brought by Speedel into Phase II, and SPP 301, an optimized oral endothelin A receptor antagonist from Roche, now promoted by Speedel into Phase I. In both cases, Speedel was able to honor the confidence received from its partners and translate its ambitious plans into action and progress.''
The clinical potential of combined (A and B) as well as of selective (either A or B) endothelin receptor antagonists is currently being evaluated by several pharmaceutical companies. Evidence from in vitro and animal testing, as well as from clinical studies suggests that endothelins may play a pivotal role in several cardiovascular diseases. Speedel has the opportunity to benefit from Roche's pioneering position in the research/drug discovery of selective and optimized endothelin receptor antagonists, and is excited to contribute to the clinical investigation and development of a selective endothelin A receptor antagonist.
Speedel was established in 1998 in Basel, Switzerland, and focuses on the development of drugs for the treatment of cardiovascular and metabolic diseases. |
