Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that it has notified the US Food and Drug Administration (FDA) that the company has placed a voluntary hold on PEARL-SC, the Phase 2b study of A-623 for the treatment of Systemic Lupus Erythematosus (lupus), due to problems found with product vials. The company was recently notified by a single clinical investigator that a number of vials of clinical product had experienced structural failure ("cracking"). After a preliminary inspection of selected product inventory at the site and at a product storage facility the company determined Monday evening that the single site finding was not an isolated problem. As a result of these findings, patient enrollment in the PEARL-SC study was immediately suspended and patients currently enrolled in the study will discontinue dosing while the company conducts a complete analysis of the problem. There have been no reports of patient-related side effects or problems with drug administration that could be attributed to this problem and to date, no serious adverse events (or SAEs) have been reported to the company in the PEARL-SC trial.
"The safety of our patients and the trust of the healthcare professionals involved in our clinical trials are of the utmost importance to Anthera so we have voluntarily placed PEARL-SC on hold until we can satisfactorily address the vial cracking that has been reported," said Paul F.Truex, CEO of Anthera Pharmaceuticals. "Getting to the root of this issue and resuming the clinical program for A-623 is a top priority. We believe that A-623 represents a promising therapeutic option for patients with autoimmune diseases and remain committed to working as quickly as possible to resolve this issue and discuss our plans with the FDA. We intend to provide a further update once those plans are in place."
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