Prolong Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy, PEGylated carboxyhemoglobin bovine (PP-007), for the treatment of acute ischemic stroke. This designation aims to accelerate the development and review of PP-007, which is currently being evaluated in the HEMERA-1 clinical trial in the USA.
Clinical Evaluation and Promising Outcomes
The HEMERA-1 trial is assessing the safety and efficacy of PP-007 in combination with intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). Italo Linfante, principal investigator of the HEMERA-1 study (Baptist Hospital, Miami, USA), noted the encouraging 90-day modified Rankin Scale (mRS) outcome measures achieved with PP-007. The trial is expanding enrollment to include patients with Alberta Stroke Program Early CT (ASPECT) scores ranging from 3 to 5.
Addressing Unmet Needs in Stroke Care
Each year, over 700,000 ischemic strokes occur in the USA, underscoring the urgent need for new and effective therapies. While treatments like IVT agents (tenecteplase and alteplase) and MT have improved outcomes, approximately 50% of patients still experience significant disabilities, particularly those with severe, large-volume strokes. PP-007 aims to improve outcomes for these patients.
Novel Mechanism of Action
Ronald Jubin, vice president of early development at Prolong, emphasized the unique potential of PP-007, stating, "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 expected to drive advances in stroke care.
Collaborative Efforts and Future Directions
Kirsten Gruis, Prolong’s chief medical officer, highlighted the company's commitment to working closely with the FDA to expedite the development of PP-007. "Recognizing 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," Gruis said.
