Anthera plans to reinitiate enrollment in its suspended Phase IIb lupus drug trial this month after an investigation determined cracks found in vials of the drug, A-623, were likely caused by extreme cold during transport.

The company still expects top-line data on A-623 in the first half of 2012, with interim results expected in the first half of this year, Anthera CEO Paul Truex said during a conference call last month. “The vial fracture patterns appeared consistent with those reported as stress or strain issues … at extreme cold temperatures,” Truex said.

The company has had no reports of patient-related side effects or problems with drug administration that can be attributed to the vial problem. Truex noted the FDA has responded to Anthera’s initial response, with no action indicated.
Drug GMP Report