Our response to COVID-19

Consistent with our mission to be a partner for better health and to collaborate with international leaders in medical research and patient care, PTx is proud to be part of the response to the emerging global health challenges posed by COVID-19. This page summarizes our progress to date and will be updated as information becomes available.

Sargramostim is a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF). GM-CSF is a naturally occurring protein that is essential for maintaining healthy lungs.

Lung dysfunction resulting in hypoxemia has been a hallmark of COVID-19.  Clinical research of sargramostim in COVID-19 was launched based on the hypothesis that it may be able to:

  • stimulate alveolar macrophages that carry anti-inflammatory properties and are responsible for removing pathogens and other debris in the lung, and
  • facilitate lung repair and healing based on its effects on alveolar epithelial cells.

The safety and efficacy of inhaled sargramostim in the treatment of patients with SARS-CoV-2 is being evaluated in clinical trials.  The preliminary results of one of the clinical trials, the SARPAC trial, are summarized here and being prepared for peer-reviewed publication.

Sargramostim is not approved by FDA for use in COVID-19 or for inhaled administration.  Of note, rhuGM-CSF has a different mechanism of action from recombinant G-CSF (granulocyte colony- stimulating factor) products and data should not be extrapolated.

Updates

SARPAC Clinical Trial of Leukine® (sargramostim, rhu GM-CSF) in Hospitalized COVID-19 Patients Meets Primary Endpoint of Significant Improvement in Lung Function

Partner Therapeutics, Inc. (PTx) announced top-line results today of the investigator-led SARPAC (Sargramostim in Patients with Acute Hypoxic Respiratory Failure and Acute COVID-19) study of inhaled Leukineâ (sargramostim, yeast-derived recombinant human GM-CSF) in hospitalized COVID-19 patients (NCT04326920).1,2  This prospective, randomized, open-label study was led by University Hospital Ghent and conducted at five hospitals in Belgium.  The study enrolled 81 patients with PCR-confirmed COVID-19 who were suffering from acute hypoxic respiratory failure requiring supplemental oxygen.  The full study and translational results are being prepared for publication.

Read our press release here

 

Partner Therapeutics Initiates Patient Enrollment in U.S. Clinical Trial Evaluating Leukine® (rhuGM-CSF, sargramostim) in COVID-19 Patients

Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced today that the first patient has been enrolled in the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine (sargramostim, rhu-GM-CSF) in hospitalized COVID-19 patients with acute hypoxemia [NCT04411680].  This study will evaluate the safety and efficacy of sargramostim in combination with institutional standard of care on clinical outcomes in these patients.

Read our press release here

 

Partner Therapeutics Announces $35 Million Contract with U.S. Department of Defense for Advanced Development and Emergency Use of Leukine® (rhuGM-CSF) for COVID-19 Acute Hypoxemic Respiratory Failure (AHRF)

Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, today anounced a $35 million milestone-based Other Transaction Agreement (OTA) with the U.S. Department of Defense (DOD) to fund two clinical studies of inhaled Leukine® (sargramostim, rhu-Granulocyte Macrophage-Colony Stimulating Factor “GM-CSF”) in patients with COVID-19 associated acute hypoxemia.

Read our press release here

 

Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine® in Respiratory Illness in Patients with COVID-19 at Singapore General Hospital

Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces the initiation of an investigator-initiated randomized, double-blind, placebo-controlled clinical trial of Leukine (sargramostim, rhu-GM-CSF) in patients with acute respiratory failure associated with COVID-19, conducted at Singapore General Hospital (NCT04400929).  The study will evaluate the effect of Leukine on lung function and other important patient outcomes.

Read our press release here

 

Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine® in Patients with COVID-19 Associated Respiratory Illness

The SARPAC study (Sargramostim in Patients with Acute Hypoxic Respiratory Failure and Acute COVID-19) is a prospective, randomized, open-label controlled study designed to assess whether inhaled Leukine (sargramostim) can restore lung function and other clinical outcomes in COVID-19 patients experiencing acute hypoxemia (NCT04326920)

See our press release for more about the SARPAC trial.