Not good news IMO...
Another psoriasis candidate bites the dust...
Tuesday May 14, 4:07 pm Eastern Time
Press Release
SOURCE: Abgenix
Phase 2B ABX-IL8 Study in Psoriasis Does Not Meet Primary Efficacy Endpoint
FREMONT, Calif.--(BW HealthWire)--May 14, 2002--Abgenix, Inc. (NASDAQ:ABGX - News) today released results of a Phase 2b study in patients with moderate to severe psoriasis that showed treatment with ABX-IL8 did not result in a significant improvement in PASI scores, the primary efficacy end point of the trial. Based on these findings, Abgenix is discontinuing clinical development of ABX-IL8 in psoriasis. In addition, the company will not proceed with a previously planned clinical study of ABX-IL8 in melanoma and will wind down its ongoing Phase 2a study in chronic obstructive pulmonary disease (COPD). Abgenix currently has no plans to conduct further clinical studies involving ABX-IL8.
As a result, Abgenix does not expect to receive revenue from an ABX-IL8 commercial collaboration this year and is now less likely to achieve its previously announced revenue target for 2002, although alternative sources of revenue are being explored. Despite this, Abgenix maintains its current operating loss guidance, before depreciation and amortization of intangibles, of $105-$120 million. Abgenix intends to achieve this from the reduced expense of clinical trials for ABX-IL8 and, if sufficient replacement revenue is not generated, by slowing previously planned headcount growth as needed.
"We are surprised and disappointed that we were unable to replicate the efficacy results shown in the phase 2a study, but we believe it is a prudent decision to curtail the ABX-IL8 program," said Ray Withy, Ph.D., president and chief executive officer of Abgenix. "We will continue to execute on our strategy of building a broad portfolio of antibody products along with the required development and manufacturing infrastructure to support such a pipeline."
The double-blind, placebo-controlled Phase 2b study randomized 256 patients to placebo, 200 mg or 300 mg of ABX-IL8 at 32 sites in the U.S. ABX-IL8 was administered every three weeks for a total of five doses. Patients were assessed at each visit and observed for up to 24 weeks after the last dose. The study's primary endpoint was the proportion of patients achieving greater than or equal to 75 percent improvement in their Psoriasis Area Severity Index (PASI) scores at Week 15 compared to baseline.
The study found ABX-IL8 was well tolerated and demonstrated an excellent safety profile. The incidence of adverse events was similar in both ABX-IL8 and placebo-treated patients. To date, no human anti-human antibodies were detected at any time point in any patient. The results showed that 3 percent of placebo-treated patients experienced greater than 75 percent improvement, compared with 2 percent of patients treated with 200 mg ABX-IL8, and 6 percent of patients treated with 300 mg. Although a retrospective analysis of study results found that ABX-IL8 reduced a measure of plaque thickening (a secondary endpoint) in the most severe patients, this result was not clinically significant. The complete findings of this study will be presented tomorrow at the 63rd Annual Meeting of the Society for Investigative Dermatology in Los Angeles, California |
