Partner Therapeutics Begins Phase 2 Inhaled Leukine Trial for COVID-19

Partner Therapeutics has enrolled the first patient in a phase 2 trial evaluating its inhaled Leukine (sargramostim) for hospitalized COVID-19 patients.

The U.S. trial will assess whether the drug can improve clinical outcomes in patients with acute hypoxemia. It will enroll 60 patients who will either receive standard of care alone or Leukine in addition to standard care.

The trial is one of two studies of inhaled Leukine as a potential treatment for COVID-19 supported by a $35 million contract from the  Department of Defense. The contract also supports expanding production capacity and a regulatory filing for a possible Emergency Use Authorization (DID, Aug. 6).

Leukine is a recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) that prompts an immune system response. It is currently in clinical testing in Belgium and Singapore for the treatment of respiratory illness associated with COVID-19 (DID, Aug. 6).

The phase 2 U.S. study is currently enrolling at the University of Utah Health, and additional sites will join the study in the coming weeks.

One of the U.S. study’s principal investigators, Robert Paine, the university’s chief of pulmonary medicine, said he believes that administering inhaled Leukine as soon as patients are hospitalized and require oxygen could “improve time to recovery, facilitate long-term healing of the lung and reduce the need for invasive procedures, such as mechanical ventilation.” — Jordan Williams