PP-007 Receives FDA Fast Track Designation for Treatment of Acute Ischemic Stroke

The FDA granted polyethylene glycol (PEG)ylated bovine carboxyhemoglobin, or PP-007 (Sanguinate, Prolong Pharmaceuticals), a novel therapy to treat acute ischemic stroke (AIS), a fast track designation, paving the way for continued research on the promising agent. The decision is based on demonstrated safety and efficacy in the HEMERA-1 clinical trial (NCT04677777).¹

The trial findings and FDA decision are crucial factors accelerating PP-007 to patients with an increased risk of an AIS. Image Credit: © Peakstock - stock.adobe.com

"Receiving fast track designation underscores the groundbreaking potential of PP-007, backed by years of research,” said Ronald Jubin, PhD, vice president of Early Development at Prolong Pharmaceuticals, in a press release. “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 [AIS].”²

AIS is the most common type of stroke, accounting for 87% of all strokes, and is the leading cause of death and severe long-term disability in the United States. According to an article published in the Journal of the American Medical Association, AIS affects over 700,000 individuals every year. AIS is a thrombotic event in which blood flow to the brain is impaired by a clot in the affected blood vessel. Typically, strokes are secondary to various cardiovascular diseases or inflammatory conditions.^3-5

PP-007 is a novel, investigational gas transfer molecule that provides pleotropic cytoprotective effects, vasodilatation, plasma expansion, and optimization of oxygen delivery. HEMERA-1 part 3 is a prospective, open-label, multicenter study that evaluates safety of 2 doses of PP-007 in patients with AIS receiving intravenous thrombolysis (IVT) or mechanical thrombectomy (MT) or IVT+MT as standard of care. In the trial, patients were randomized to receive either PP‐007 (320 mg/kg: 30 min bolus followed by 2‐h infusion) plus MT or MT alone within 24 hours after symptom onset in a 3:1 ratio.^5,6

According to the preliminary trial data, all patients achieved recanalization of the occluded vessel, as well as a transient systolic blood pressure increase of 20 to 40 mm Hg during bolus without any clinical consequences. Additionally, the researchers noted no significant safety concerns.⁶⁶

“We are increasingly encouraged by the promising 90-day Modified Rankin Score outcome measures achieved with PP-007 treatment in combination with IVT and MT, particularly as we expand enrollment to include patients with [Alberta stroke program early CT score (ASPECTS)] scores ranging from 3 to 5,” said principal HEMERA-1 study investigator Italo Linfante, MD, director of interventional neuroradiology at the Baptist Hospital in Miami, Florida, in a press release.²²

The trial findings and FDA decision are crucial factors accelerating PP-007 to patients with an increased risk of AIS. Expediting the development of the agent can help improve survivability and quality of life outcomes for affected patients.

REFERENCES

1. Safety study of pp-007 in subjects with acute ischemic stroke (hemera-1). ClinicalTrials.gov Identifier: NCT04677777. Updated August 29, 2024. Accessed November 4, 2024. https://clinicaltrials.gov/study/NCT04677777?tab=results

2. U.s. food and drug administration (fda) grants prolong pharmaceuticals fda fast track designation for novel stroke therapy (pp-007) in hemera-1 clinical study. Business Wire. October 30, 2024. Accessed November 4, 2024. https://www.businesswire.com/news/home/20241030373967/en

3. Stroke facts. CDC. Accessed November 4, 2024. https://cdc.gov/stroke/data-research/facts-stats/index.html

4. Walter K. What is acute ischemic stroke. JAMA. March 1, 2022. doi:10.1001/jama.2022.1420

5. Hui C, Tadi P, Suheb M, et al. Ischemic stroke. StatPearls [Internet]. April 20, 2024. https://www.ncbi.nlm.nih.gov/books/NBK499997/#:~:text=During%20an%20acute%20ischemic%20stroke,some%20blood%20supply%20through%20collateral

6. Linfante I, Clark W, Haussen D, et al. Hemera‐1 carboxyhemoglobin oxygen delivery for evascularization in acute stroke: a prospective, randomized phase 1 clinical trial. April 23, 2024. doi:10.1161/SVIN.123.001246