Prolong Pharmaceuticals to Present Preliminary Phase 1 Data for PP-007 in AIS at 2025 ISC
Phase 1 Data Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, is poised to make a significant contribution to the field of acute ischemic stroke (AIS) treatment with the presentation of its latest clinical data at the 2025 International Stroke Conference (ISC) in Los Angeles, California.
Phase 1 Data The company will showcase its lead asset, Phase 1 Data PP-007, a PEGylated carboxyhemoglobin bovine product, which has demonstrated promising results in its Phase 1 clinical trial. This data, coming from the HEMERA-1 trial, will be featured during a poster presentation that aims to highlight the safety, efficacy, and pharmacokinetics of Phase 1 Data PP-007 in AIS.
The presentation is slated for Wednesday, February 5, 2025, from 7:00 PM to 7:30 PM PT in Hall G. Dr. Italo Linfante, the Medical Director of Interventional Neuroradiology at Miami Neuroscience Institute and Baptist Health South Florida, will serve as the presenter and will offer an in-depth look at the trial’s findings.
Dr. Linfante, who is also the Principal Investigator (PI) of the HEMERA-1 trial, will present the details of the study in a session titled “HEMERA-1: CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke: A Multi-Step clinical study of safety, efficacy and Pharmacokinetics.”
The HEMERA-1 trial marks a critical milestone for Prolong Pharmaceuticals as it recently completed the enrollment of participants for Part 3 of the study. This final phase of the trial will provide essential data that may influence the trajectory of PP-007’s development.
Moreover, Phase 1 Data the company has successfully completed the final Data Safety Monitoring Board (DSMB) review, which showed no significant safety signals, further reinforcing the potential of PP-007 as a viable treatment for AIS. With the DSMB’s positive assessment, Prolong is now preparing for the next steps in the development of PP-007, including the planning of the HEMERA-2 global Phase 3 randomized clinical trial, which will be pivotal in determining whether PP-007 can gain regulatory approval for widespread use.
The HEMERA-1 Trial: A Breakthrough in Acute Ischemic Stroke Treatment
Acute ischemic stroke is a leading cause of death and disability worldwide. The condition occurs when a blood clot obstructs a blood vessel in the brain, leading to oxygen deprivation and tissue damage. Timely intervention is crucial in minimizing long-term brain damage and improving patient outcomes. However, despite significant advancements in stroke treatment, there remains a need for new therapies that can address the underlying causes of AIS more effectively.
Phase 1 Data PP-007, the drug being developed by Prolong Pharmaceuticals, aims to address this gap. The compound is a PEGylated carboxyhemoglobin bovine product designed to deliver oxygen to the brain more efficiently. B
y carrying oxygen directly to the brain tissues, PP-007 aims to support the revascularization process in patients who have suffered an acute ischemic stroke. The potential of PP-007 lies in its ability to deliver oxygen quickly, allowing the brain tissue to recover faster and reducing the long-term damage typically associated with stroke.
The Phase 1 trial, HEMERA-1, is focused on assessing the safety, efficacy, and pharmacokinetics of PP-007. The results of the trial have been promising, with no significant safety concerns identified during the final DSMB review. This sets the stage for further testing in Phase 3 trials, where Prolong Pharmaceuticals intends to expand the study’s scope to a larger patient population across multiple global sites.
A Promising Future: The Transition to Phase 3 and Regulatory Approval
The transition from Phase 1 to Phase 3 trials is a significant milestone in the drug development process. It marks a shift from initial safety assessments to a more comprehensive evaluation of the drug’s effectiveness in a broader patient population. For PP-007, this step is crucial in its journey toward regulatory approval and eventual commercialization.
Phase 1 Data Prolong Pharmaceuticals is actively working on the design of the Phase 1 Data HEMERA-2 trial, which will be a global Phase 3 randomized clinical trial. The results from this study will determine whether PP-007 can provide measurable benefits to patients suffering from acute ischemic stroke.
Prolong Pharmaceuticals’ leadership team, including Dr. Italo Linfante, is optimistic about the drug’s future. Dr. Linfante commented on the significance of the trial’s results, saying, “We are encouraged by the positive findings from the Phase 1 trial, particularly the successful completion of the final DSMB review, which reinforces PP-007’s safety profile. The Prolong team is actively planning HEMERA-2, which will be a critical step toward regulatory approval.”
The HEMERA-2 trial will be designed to evaluate PP-007’s efficacy in a large, diverse population of AIS patients. The results of this trial will play a pivotal role in shaping Prolong Pharmaceuticals’ strategy for regulatory submission to health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If successful, PP-007 could become a game-changer in the treatment of AIS, offering a new, faster way to address the immediate oxygen deprivation caused by strokes and enhancing recovery prospects for patients.
The Science Behind PP-007: A New Approach to Stroke Treatment
PP-007’s innovative approach to treating acute ischemic stroke sets it apart from other therapies currently in development. Traditional treatments for AIS primarily focus on clot removal and restoring blood flow through mechanical thrombectomy or clot-busting drugs.
While these therapies can be effective, they often come with limitations and risks. Phase 1 Data PP-007, on the other hand, works through a fundamentally different mechanism by delivering oxygen directly to the affected brain tissue, potentially reducing the time to recovery and improving long-term outcomes.
The key component of PP-007 is carboxyhemoglobin, which is a modified form of hemoglobin that can bind to oxygen more efficiently than regular hemoglobin. When administered as part of the PEGylated carboxyhemoglobin formulation, PP-007 is able to deliver oxygen directly to the brain cells in need, bypassing the usual blood flow restrictions caused by clots or other blockages. This direct oxygen delivery could be particularly beneficial in the acute phase of stroke when rapid intervention is essential.
In addition to its innovative mechanism of action, PP-007 also benefits from its PEGylated formulation, which allows for longer circulation times in the bloodstream. PEGylation is the process of attaching polyethylene glycol (PEG) molecules to a drug, which helps the drug stay in the body longer and enhances its therapeutic effects.
This feature makes PP-007 a promising candidate for treating acute ischemic stroke, as it can maintain its efficacy for a longer period, allowing for better management of oxygen levels in the brain.
The Future of Acute Stroke Treatment: Global Implications
If PP-007 Phase 1 Data proves successful in Phase 3 trials and gains regulatory approval, it could have far-reaching implications for the treatment of acute ischemic stroke. The ability to rapidly restore oxygen to the brain following a stroke would offer a significant improvement over existing therapies, which often require a more complex series of interventions. This could reduce the overall burden on healthcare systems and improve the quality of life for stroke survivors.
Phase 1 Data Prolong Pharmaceuticals is focused not only on the success of PP-007 in the United States but also on global expansion. The company’s efforts to expand the HEMERA-2 trial to multiple countries reflects the importance of understanding how PP-007 performs in different patient populations worldwide. A global trial will also help Prolong Pharmaceuticals navigate the regulatory landscapes of various health authorities and increase the likelihood of rapid adoption across markets.
The company’s commitment to advancing PP-007 Phase 1 Data for acute ischemic stroke reflects a broader trend in the pharmaceutical industry toward developing more targeted, efficient treatments for urgent medical conditions. As stroke remains a leading cause of disability and death, there is a critical need for therapies that can provide immediate relief and long-term benefits. Phase 1 Data PP-007 has the potential to fill this gap, offering hope to the millions of people affected by this debilitating condition.
