FDA Grants Fast Track Designation to Prolong Pharmaceuticals' PP-007 for Acute Ischemic Stroke
Key Insights
The FDA has granted Fast Track designation to PP-007, Prolong Pharmaceuticals (search)' investigational therapy, for acute ischemic stroke (search) (AIS).
PP-007 is currently in the HEMERA-1 clinical trial, evaluating its safety and efficacy in U.S.-based patients with acute ischemic stroke (search).
PP-007's unique mechanism includes opening collateral vessels, selectively delivering oxygen to hypoxic neurons (search), and reducing inflammation.
Prolong Pharmaceuticals (search), LLC, a clinical-stage biopharmaceutical company, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), for the treatment of acute ischemic stroke (search) (AIS). The designation aims to expedite the development and review of PP-007, which is currently being evaluated in the HEMERA-1 clinical trial. This study assesses the safety and efficacy of PP-007 in patients with AIS across multiple stroke centers in the United States.
Novel Mechanism of Action
PP-007 is distinguished by its unique combination of mechanisms designed to improve outcomes in stroke patients. According to Ronald Jubin, Ph.D., Vice President of Early Development at Prolong Pharmaceuticals (search), PP-007 opens collateral vessels, selectively delivers oxygen to hypoxic neurons (search), reduces inflammation, and sustains these effects for 24 hours, as demonstrated in pharmacokinetic studies. These capabilities address critical unmet needs in acute ischemic stroke (search) care.
Unmet Needs in Stroke Treatment
Each year, over 700,000 ischemic strokes occur in the United States, highlighting the urgent need for new and improved therapies. While treatments like intravenous thrombolytic agents (TNKase® and Activase®) and mechanical thrombectomy (MT) have advanced stroke care, approximately 50% of patients still experience significant disabilities, particularly those with severe, large-volume strokes. Dr. Italo Linfante, Principal Investigator of the HEMERA-1 study at Baptist Hospital in Miami, FL, noted the encouraging 90-day mRS outcome measures achieved with PP-007 treatment in combination with IVT and MT, especially as enrollment expands to include patients with ASPECT scores ranging from 3 to 5.
HEMERA-1 Study Details
The HEMERA-1 study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke) is a randomized, blinded, contemporaneously controlled trial evaluating the safety, tolerability, efficacy, and pharmacokinetics of PP-007 in acute ischemic stroke (search) patients. Key eligibility criteria and outcome measures are detailed on www.clinicaltrials.gov (NCT04677777).
About PP-007
PP-007 (PEGylated carboxyhemoglobin bovine, also known as SANGUINATE®) is a novel clinical-stage biopharmaceutical product. It has been studied in over 300 individuals across 12 clinical trials, including those with subarachnoid hemorrhage, severe life-threatening anemia, and other conditions with ischemia/hypoxia. PP-007 is currently an investigational drug and not approved for use in any country or indication.
Company Focus
Prolong Pharmaceuticals (search) is dedicated to developing PP-007 to reduce the debilitating comorbidities associated with reduced quality of life, increased medical costs, and significant mortality in acute ischemic stroke (search) patients.