FDA

Prolong Pharmaceuticals gains US FDA fast-track designation for novel stroke therapy

Prolong Pharmaceuticals has announced that its investigational therapy — PEGylated carboxyhemoglobin, bovine (PP-007) — has received a fast-track designation from the US Food and Drug Administration (FDA) for the treatment of acute ischaemic stroke. PP-007 is currently being evaluated for safety and efficacy in the ongoing, USA-based HEMERA-1 clinical trial.

“We are increasingly encouraged by the promising 90-day mRS [modified Rankin scale] outcome measures achieved with PP-007 treatment in combination with IVT [intravenous thrombolysis] and MT [mechanical thrombectomy], particularly as we expand enrolment to include patients with ASPECT [Alberta stroke programme early computed tomography] scores ranging from 3 to 5,” said HEMERA-1 study principal investigator Italo Linfante (Baptist Hospital, Miami, USA).

As outlined in a recent Prolong press release, more than 700,000 ischaemic strokes occur in the USA alone each year, highlighting the critical relevance of new therapies to address unmet medical needs in stroke care. While advances like IVT agents — including tenecteplase and alteplase — and the MT procedure have improved outcomes, approximately 50% of patients still experience significant disabilities, the release details, also noting that this percentage is even higher among those suffering from severe, large-volume strokes.

“Receiving fast-track designation underscores the groundbreaking potential of PP-007, backed by years of research,” said Ronald Jubin, vice president of early development at Prolong. “We believe no other stroke drug in development offers this unique combination: opening collateral vessels; selectively delivering oxygen to hypoxic neurons; reducing inflammation; and sustaining effects for 24 hours, as shown in pharmacokinetic studies with acute stroke patients. These capabilities — demonstrated in multiple PP-007 studies — are driving advances in stroke care and addressing critical unmet needs in acute ischaemic stroke.”

“Recognising annual World Stroke Day [29 October], we are excited to closely collaborate with the FDA to expedite the development of PP-007 to improve survival and quality-of-life outcomes in acute ischaemic stroke patients,” added Kirsten Gruis, Prolong’s chief medical officer.