Shares in Switzerland's Speedel fell over 14% after the company announced that it is halting Phase III tests on a new diabetic kidney drug.
The firm said that it has stopped a pivotal Phase III clinical trial of SPP301 (avosentan) in diabetic kidney disease, on the recommendation of the independent monitoring board looking at the study after a significant imbalance in fluid retention in patients was noted.
The bad news comes just a month after Speedel said that delays in recruiting patients for the Phase III trial would slow down completion of the study, called Ascend, for three to six months. However the Basle-based firm is not overly downhearted and has not given up on the compound, saying that it will be evaluated for potential new clinical trials in diabetic kidney disease and other indications. Its plans for SPP301 will be announced in the middle of next year.
Jessica Mann, Speedel's medical director, noted that fluid retention is not unusual in patients who have severe diabetic kidney disease but "given the fragility of these patients, the company is being prudent in not continuing to expose them to any further complications." The firm’s chief executive, Alice Huxley, admitted that stopping the trial "is a setback" but "it demonstrates the potential risks linked to the pharmaceutical industry's pursuit of innovation."
Others, however, feel it is more than a setback, especially as it comes a week after Speedel's partner Novartis revealed that US regulatory approval for Tekturna (aliskiren), the firms' renin inhibitor for hypertension, will be delayed by up to three months as the Food and Drug Administration reviews new data.
Tekturna is the only drug that Speedel has left in the late-stage pipeline and a prompt launch is in its interests cash-wise as Lehman Brothers, which initiated coverage on the stock with an 'overweight rating,' noted the firm will receive estimated royalties of 11% on Tekturna sales.