Abbott Laboratories has decided not to exercise a license-back option on SPP200, a drug for patients undergoing chronic haemodialysis in development at Swiss firm Speedel.
Abbott acquired the option on the direct thrombin inhibitor as part of its takeover of Knoll in 2002 and licensed it to Speedel the following year in order for the Swiss company to undertake proof-of-principle development.
Speedel said it would now have discussions with the US Food and Drug Administration to explore taking SPP200 forward under its own banner. The drug has positive Phase II results in the bag, and would join Speedel’s renin inhibitor Rasilez (aliskiren) – partnered with Novartis and already filed for approval – as well as SPP301, and endothelin A receptor antagonist licensed to Roche, which is in Phase III trials in diabetic nephropathy patients.
The Phase II trial of SPP200 was conducted in the US in 127 patients to assess the safety profile of the drug and the reduction of vascular graft occlusion in patients undergoing chronic haemodialysis for end- tage renal disease.
The study compared the safety and efficacy profile of SPP200 to that of unfractionated heparin (UFH) which, in the USA, is the gold standard anti-coagulant in haemodialysis.
The results showed that the frequency of vascular graft occlusions was significantly lower with SPP200 than with UFH, and the probability of patients having a vascular graft occlusion was around three times lower with Speedel’s drug. Major bleeds were rare with either treatment, although there were more minor bleeds with SPP200 than UFH.
Meanwhile, the Swiss firm reported an increase in second-quarter net losses to 25 million Swiss francs, up from 18 million francs a year ago, resulting from higher research and development and financing costs. Speedel has close to 150 million francs in liquid assets, which should take it through to the first quarter 2008, regardless of whether it decides to press on with the development of SPP200 in-house.