Prolong Pharmaceuticals has announced that its investigational therapy, pegylated carboxyhaemoglobin bovine (PP-007), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the treatment of acute ischaemic stroke with anterior-circulation large vessel occlusion (LVO).
In a press release, the company notes that BTD is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where preliminary clinical evidence indicates the potential to demonstrate substantial improvement over existing therapies on clinically meaningful endpoints.
“This designation from the US FDA supports the significant potential of PP-007, a novel therapeutic that improves oxygen delivery and cerebral blood flow, to be a first-in-class therapy to improve outcomes in acute ischaemic stroke patients with anterior-circulation LVOs,” said Kirsten Gruis, chief medical officer at Prolong.
“This BTD builds on PP-007’s existing fast-track designation, further strengthening Prolong’s collaborative pathway with the US FDA to bring a much-needed treatment to LVO acute ischaemic stroke patients as efficiently as possible,” added John Pakulski, the company’s senior vice president of regulatory affairs.
PP-007 is an investigational therapy designed to improve oxygen delivery in ischaemic tissue. The therapy is currently being evaluated under an active investigational new drug (IND) application, according to Prolong.
