Alexion Pharmaceuticals, Inc. (ALXN) reported disappointing data from a phase II study evaluating Soliris (eculizumab) for the prevention of antibody mediated rejection (AMR) in living-donor kidney transplant recipients requiring desensitization. We except investors to react negatively to the news.
The randomized, open-label, multi-center phase II study enrolled 102 patients receiving kidney transplants from living donors, all of whom were at risk of AMR, based on elevated levels of donor-specific antibodies. The study failed to meet its primary composite (occurrence of biopsy-proven AMR, graft loss, patient death, or loss to follow-up) endpoint. Analysis of 9-week data revealed that the primary composite endpoint rates were 9.8% and 15.7% in the Soliris arm and the control arm, respectively. The difference was not statistically significant.
As per the company press release, the historical rate of AMR in high-risk living-donor kidney transplant recipients has been observed to be as high as 41%. Currently, there are no FDA approved drugs for the prevention or treatment of acute AMR.
Soliris is currently approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Alexion is also developing Soliris for other indications including the prevention of delayed graft function in renal transplant patients, neuromyelitis optica and myasthenia gravis. Approval for additional indications would boost the drug’s sales potential.
Alexion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD), Affymetrix Inc. (AFFX) and Incyte Corporation (INCY). All three stocks carry a Zacks Rank #1 (Strong Buy).
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