Nuvelo Discontinues Alfimeprase After Disappointing Efficacy Results
This article was originally published in The Pink Sheet Daily
Executive Summary
After discontinuing its only late-stage drug candidate, Nuvelo is back at Phase I.
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Nuvelo halted development of its only late-stage drug, the anti-clotting medication alfimeprase, in both catheter occlusion and acute ischemic stroke after a Phase II trial in catheter occlusion failed to show sufficient efficacy, the company said March 17. As a result of the decision to discontinue development of the recombinant direct acting fibrinolytic, Nuvelo will restructure. The company plans to cut about 40 full-time equivalents, and Exec VP-R&D Michael Levy will leave the firm. San Carlos, Calif.-based Nuvelo expects to incur restructuring charges of approximately $3 million in the first quarter, primarily from severance payments. It estimates operating expenses for the year at about $47 million to $52 million. Nuvelo had $103.6 million in cash and cash equivalents on hand Dec. 31. Nuvelo faced setbacks with alfimeprase last year, but voiced confidence in the drug candidate. The company lost Bayer as its development partner after alfimeprase failed a Phase III catheter occlusion trial, SONOMA-2, and another study in patients with acute peripheral arterial occlusion (1 (Also see "For Now, Nuvelo Will Go It Alone On Thrombolytic Alfimeprase" - Pink Sheet, 27 Jun, 2007.)). Nonetheless, the firm ran a new Phase II OC study, SONOMA-3, measuring the drug at a greater dosage and higher concentration. It separately announced the initiation of a Phase II trial, CARNEROS-1, in ischemic stroke patients in December (2 (Also see "Nuvelo Begins Phase II Trial Of Thrombolytic For Ischemic Stroke" - Pink Sheet, 13 Dec, 2007.)). As it turns out, SONOMA-3 failed to show sufficient improvement in catheter opening at the higher dose and concentration to meet the targeted product profile, Nuvelo said. "Our stated value proposition for alfimeprase in catheter occlusion was to restore function with similar efficacy to Cathflo Activase , but with a much shorter timeframe," CEO Ted Love said during a same-day conference call. Genentech's Cathflo Activase (alteplase), already marketed for catheter occlusion, restored catheter function in more than 80 percent of occluded catheters within two to four hours in a study. In SONOMA-3, alfimeprase restored catheter function in about 50 percent of patients at 15 minutes and 60 percent of patients at one hour. Despite the benefit, the one-hour clearance rate fell below the company's expectations, Nuvelo noted. "What we're really trying to do at Nuvelo is make some advances that are ultimately going to be important for patients and important in the marketplace, and we just don't see [that] launching a drug that essentially does what Cathflo Activase does makes any sense," Love stated. "We set the bar high. We didn't get to the bar." The firm's decision to discontinue development in catheter occlusion also knocks out Nuvelo's development plans in stroke. "Our original development strategy with alfimeprase was to pursue the drug in multiple indications including stroke, catheter occlusion, peripheral arterial occlusion and potentially other indications," Love said. "Now that we are not moving forward in catheter occlusion or PAO, pursuing alfimeprase in stroke only is too risky and too expensive." The decision to shut down alfimeprase leaves Nuvelo with two Phase I programs. The company is on track to report top-line data from a proof-of-concept trial with NU172, a direct thrombin inhibitor in development as a short-acting anticoagulant during medical procedures, in the first half of the year. The other candidate, NU206, a Wnt pathway modulator for treatment of chemotherapy induced mucositis and inflammatory bowel disease, also is on a similar timeline for reporting data. -Jessica Merrill ([email protected]) |