BioWorld International Correspondent

Speedel Development AG, a subsidiary of Speedel Holding AG, of Basel, Switzerland, moved its oral endothelin A receptor antagonist SPP 301 into Phase II pilot studies following the successful conclusion of Phase I studies in healthy volunteers.

The company, which licensed the compound from Basel-based F. Hoffmann-La Roche Ltd. in 2000, is keeping its development plans under wraps. "We believe it is a competitive advantage not to disclose the indication we want to go into," project director Thierry Briand told BioWorld International.

The pilot trial is not a registration study, but is designed to yield further information about the compound before it proceeds to full Phase II trials. "We want to confirm some of the strategic directions we have taken," Briand said.

Another Swiss firm, Allschwil-based Actelion Ltd., has already developed an oral endothelin receptor antagonist, bosentan, which gained FDA approval for treatment of pulmonary arterial hypertension in November. Earlier this year, the same compound failed to show efficacy in Phase III clinical trials of patients with severe chronic heart failure. SPP301 differs from bosentan, Briand said, because it binds to the endothelin A receptor specifically, whereas bosentan binds to both A and B receptor subtypes.

"Versus bosentan, it's more potent and it's more selective," he said. "Otherwise, we would not have selected it."

Speedel already has another compound, Aliskiren (SPP 100), in clinical development. The compound, an oral renin inhibitor, is in Phase II studies for treatment of hypertension. "It is going to enter into Phase III [trials] soon," Briand said. The company licensed that molecule from Basel-based Novartis AG in 1999. It subsequently acquired worldwide rights to Novartis' renin inhibitor program, which covers a new class of compounds discovered by the pharmaceutical company.

Speedel, which is targeting metabolic and cardiovascular indications, was established in 1998 with a senior management team drawn from Switzerland's pharmaceutical industry. CEO and President Alice Huxley was global project manager at Novartis Pharma AG; Dieter Scholer is a former head of cardiovascular and central nervous system drug discovery at Ciba Pharmaceuticals; and Medical Director Jessica Mann has worked in academia and at both Novartis and Roche. The company has so far raised CHF44 million (US$27.9 million) in equity funding and an additional CHF38 million through a convertible loan and R&D support.