Prolong Pharmaceuticals Reports Promising Phase 1/2 Results for PP-007 in Acute Ischemic Stroke
核心洞察
Prolong Pharmaceuticals (搜索) will present Phase 1/2 HEMERA-1 trial data for PP-007 at the 2025 World Stroke Conference, showing improved functional outcomes in acute ischemic stroke patients.
PP-007 demonstrated a 20% absolute improvement in functional independence at 90 days and 55% early responder rate when added to standard care in anterior large vessel occlusion patients.
The FDA-granted Fast Track designated therapy showed significantly improved outcomes and reduced mortality compared to mechanical thrombectomy alone, supporting advancement to pivotal trials.
Prolong Pharmaceuticals (搜索) announced it will present encouraging Phase 1/2 clinical data for PP-007, a PEGylated carboxyhemoglobin bovine product, in acute ischemic stroke (AIS) patients at the World Stroke Conference in Barcelona, Spain, October 22-24, 2025. The HEMERA-1 trial results demonstrate significant improvements in functional outcomes when PP-007 is administered alongside standard care for anterior large vessel occlusion (A-LVO) AIS patients.
Clinical Trial Results Show Strong Efficacy Signals
The HEMERA-1 study achieved its primary objective, demonstrating that PP-007 was generally well tolerated and delivered robust proof-of-concept signals when added to standard-of-care therapy. In patients with anterior large vessel occlusion, PP-007 treatment resulted in a 20% absolute improvement in functional independence compared to expected 90-day outcomes. Additionally, 55% of patients achieved early responder status marked by rapid neurological recovery during hospitalization.
According to the latest data, PP-007 demonstrated significantly improved functional outcomes and reduced mortality when compared to patients receiving mechanical thrombectomy alone. Dr. Kirsten Gruis, Chief Medical Officer of Prolong Pharmaceuticals (搜索), stated that these encouraging results support PP-007's potential to meaningfully improve outcomes in AIS.
Expert Commentary and Clinical Significance
Dr. Raul Nogueira, Scientific Advisory Board Member of the PP-007 program, commented on the trial results: "The HEMERA-1 data are very encouraging — despite the smaller, prospectively matched cohort, we observed signals suggesting improved functional outcomes compared to typical benchmarks in acute ischemic stroke. These findings clearly warrant validation in a fully powered randomized clinical trial."
Regulatory Progress and Next Steps
PP-007 has been granted Fast Track Designation by the FDA for acute ischemic stroke in 2024, recognizing the significant unmet medical need in this indication. The company is currently preparing for its global pivotal study, HEMERA-2, which has been aligned with the FDA following a successful Type C meeting earlier this year.
About PP-007 and Development Program
PP-007 (PEGylated carboxyhemoglobin bovine—SANGUINATE®) is a novel biopharmaceutical product that is universally compatible, thermally stable, and available in a ready-to-administer intravenous formulation. The therapy has demonstrated improvement in blood flow, oxygen transfer, inflammation reduction, and supports perfusion and organ function across multiple pre-clinical and clinical studies.
Approximately 300 individuals across 12 completed clinical trials have received single and multi-dose PP-007 treatments for various conditions including subarachnoid hemorrhage, life-threatening anemia, and other diseases with underlying ischemia/hypoxia, such as beta thalassemia and sickle cell disease. PP-007 remains an investigational drug product and is not approved for use in any country or indication.
Prolong Pharmaceuticals (搜索) is an advanced clinical-stage pharmaceutical company with a vertically integrated, proprietary manufacturing facility headquartered in South Plainfield, New Jersey. The company is developing PP-007 as a treatment for AIS to address the debilitating comorbidities associated with reduced quality of life, increased medical costs, and significant mortality in stroke patients.