Prolong Pharmaceuticals has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS). PP-007 is currently being evaluated for safety and efficacy in an ongoing U.S.-based clinical trial, HEMERA-1.
"Receiving Fast Track designation underscores the groundbreaking potential of PP-007, backed by years of research. We believe no other stroke drug in development offers this unique combination: (1) opening collateral vessels, (2) selectively delivering oxygen to hypoxic neurons, (3) reducing inflammation, and (4) 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 ischemic stroke," stated Ronald Jubin, Ph.D. Vice President of Early Development at Prolong Pharmaceuticals.
Each year, over 700,000 ischemic strokes occur in the United States alone, highlighting the critical need for new therapies to address unmet medical needs in stroke care. While advances such as intravenous thrombolytic agents—TNKase® (tenecteplase) and Activase® (alteplase)—and the mechanical thrombectomy (MT) procedure have improved outcomes, approximately 50% of patients still experience significant disabilities. This percentage is even higher among those suffering from severe, large-volume strokes. “We are increasingly encouraged by the promising 90-day mRS outcome measures achieved with PP-007 treatment in combination with IVT and MT, particularly as we expand enrollment to include patients with ASPECT scores ranging from 3 to 5,” said Dr. Italo Linfante, Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL.
“Recognizing annual World Stroke Day, 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 AIS patients,” said Dr. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals.
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