PP-007 Receives FDA Fast Track Designation for Acute Ischemic Stroke Treatment
Key Insights
The FDA granted Fast Track designation to PP-007, a novel therapy for acute ischemic stroke (search) (AIS), based on promising safety and efficacy data from the HEMERA-1 trial.
PP-007 exhibits a unique combination of mechanisms, including opening collateral vessels, selectively delivering oxygen to hypoxic neurons, and reducing inflammation.
Preliminary data from the HEMERA-1 trial showed successful recanalization of occluded vessels and no significant safety concerns with PP-007 in combination with IVT and MT.
Prolong Pharmaceuticals (search)' PP-007 (PEGylated bovine carboxyhemoglobin) has been granted Fast Track designation by the FDA for the treatment of acute ischemic stroke (search) (AIS). This decision, based on demonstrated safety and efficacy in the HEMERA-1 clinical trial (NCT04677777), is set to accelerate the development of this novel therapy for patients at increased risk of AIS.
Novel Mechanism of Action
PP-007 is an investigational gas transfer molecule designed to provide pleiotropic cytoprotective effects, vasodilatation, plasma expansion, and optimized oxygen delivery. According to Ronald Jubin, PhD, vice president of Early Development at Prolong Pharmaceuticals (search), PP-007's unique combination of opening collateral vessels, selectively delivering oxygen to hypoxic neurons, reducing inflammation, and sustaining effects for 24 hours sets it apart from other stroke drugs in development.
HEMERA-1 Trial Details
The HEMERA-1 trial is a prospective, open-label, multicenter study evaluating the safety of two doses of PP-007 in AIS patients receiving intravenous thrombolysis (IVT), mechanical thrombectomy (MT), or IVT+MT as standard of care. Patients were randomized in a 3:1 ratio to receive either PP-007 (320 mg/kg: 30-minute bolus followed by 2-hour infusion) plus MT or MT alone within 24 hours after symptom onset.
Preliminary Trial Data
Preliminary data from the trial indicated that all patients achieved recanalization of the occluded vessel. Researchers also observed a transient systolic blood pressure increase of 20 to 40 mm Hg during bolus administration, without any clinical consequences. No significant safety concerns were reported.
Clinical Perspective
Italo Linfante, MD, principal investigator of the HEMERA-1 study and director of interventional neuroradiology at the Baptist Hospital in Miami, Florida, noted the encouraging 90-day Modified Rankin Score outcome measures achieved with PP-007 treatment in combination with IVT and MT. He also highlighted the expansion of enrollment to include patients with Alberta stroke program early CT scores (ASPECTS) ranging from 3 to 5.
Impact on Stroke Treatment
AIS, the most common type of stroke, accounts for 87% of all strokes and is a leading cause of death and long-term disability in the United States, affecting over 700,000 individuals annually. The Fast Track designation for PP-007 is a crucial step toward expediting the availability of this agent, potentially improving survivability and quality of life outcomes for affected patients.