Cracked Vials Lead to Suspension of Dosing in Anthera Lupus Trial

Cracked vials may set back Anthera Pharmaceuticals’ development plans for its lupus candidate, A-623. The company decided to suspend enrollment and dosing in the Phase IIb PEARL-SC trial after a site in the U.S. reported a number of cracked vials of the study product. A preliminary inspection of the site’s inventory and product storage facilities revealed the cracking was not an isolated problem, Anthera CEO Paul Truex said in a conference call.
Clinical Trials Advisor