#United States #Lexington #LEUKINE #sepsis #BARDA

BARDA and Partner Therapeutics Team Up to Tackle Sepsis

In a significant step towards improving the treatment of sepsis, Partner Therapeutics, Inc. (PTx) has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA), an essential agency within the U.S. Department of Health and Human Services. The collaboration aims to fund a crucial phase 2 clinical study evaluating the safety and dosage of LEUKINE® (sargramostim) in patients suffering from sepsis.

The Challenge of Sepsis

Sepsis, a life-threatening condition that arises from the body's extreme response to an infection, results in organ dysfunction. It presents a substantial challenge to public health, with approximately 1.7 million cases reported annually in the United States, leading to nearly 270,000 deaths. The immune system's erratic behavior during sepsis often leads to significant morbidity and mortality, demonstrating a critical need for effective therapeutic options.

No Ordinary Partnership

The PTx-BARDA partnership is particularly focused on enhancing immune system functionality in patients with sepsis who exhibit long-term immune suppression. The aim is to restore immune homeostasis, which is often disrupted during severe infections. Research suggests that patients with heightened immune suppression are less capable of responding to infections, leading to increased mortality rates.

The clinical study will further investigate the potential of LEUKINE to promote immune recovery. It will also examine biomarkers such as monocyte human leukocyte antigen-DR (mHLA-DR) to identify sepsis patients who could benefit most from this therapeutic intervention. By employing validated biomarkers for precision medicine, the partnership hopes to personalize treatment methodologies and improve patient outcomes.

LEUKINE: A Promising Solution

LEUKINE is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) designed to promote immune system recovery. It holds promise in addressing distinct immune dysfunctions observed in sepsis. Clinical evidence suggests that LEUKINE accelerates the recovery of neutrophil counts and displays favorable outcomes in improving overall patient survival rates.

In previous studies, LEUKINE has demonstrated the ability to significantly enhance immune function characteristics, contributing to improvements in both 28-day survival rates and infection resolution. By focusing on immune homeostasis, LEUKINE could provide the necessary support to critically ill patients battling sepsis.

The Role of mHLA-DR

The partnership also emphasizes the importance of mHLA-DR as a potential biomarker for assessing immune status in patients with sepsis. Under a previous collaboration, BARDA and PTx established a Laboratory Developed Test (LDT) for this purpose, which will be utilized in the ongoing study. The use of mHLA-DR presents an opportunity for more targeted therapies that can lead to better and faster recovery for sepsis patients.

As John L. McManus, President of Health Security and Critical Care at PTx, noted, this partnership signifies a major advancement in sepsis treatment, aiming to leverage immune status measurements for more effective immunomodulatory therapies.

Funding and Future Directions

This initiative is supported in part by federal funds, enhancing the collaboration's potential to deliver substantial advancements in the management of sepsis. As sepsis continues to pose a significant threat to health security, the study's outcomes could ultimately benefit a broader population, particularly those vulnerable to chemical, biological, radiological, and nuclear (CBRN) threats—conditions often exacerbated by complications related to sepsis.

With increasing awareness and understanding of the sepsis condition, the PTx and BARDA partnership promises to pioneer new pathways for effective treatment, emphasizing the importance of immune restoration in managing this complex and life-threatening reaction to infection.

In summary, the collaboration between Partner Therapeutics and BARDA represents hope for enhancing patient care for those suffering from sepsis. With promising avenues for therapeutic intervention and a focus on personalized medicine, the possibilities for improved patient outcomes are on the horizon.