Partner Therapeutics, Inc. (PTx) will receive 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. The program will evaluate the effect of Leukine in improving clinical outcomes, including oxygenation and percent of patients intubated. The first of the two clinical studies (NCT04411680) will be initiated in August 2020 in centers in the U.S., and will be conducted under an Investigational New Drug (IND) Application, approved by the U.S. FDA on May 20, 2020.
The milestone-based Firm Fixed Price (FFP) agreement will fund two Phase 2 studies to assess the benefits of Leukine in the treatment of patients with acute hypoxemia due to COVID-19. Funding will also support regulatory filings for a potential EUA and expansion of production capacity to meet increased demand.
In March 2020, PTx announced that Leukine is being assessed in the SARPAC clinical trial currently underway in Belgium to treat patients with respiratory illness associated with COVID-19 (NCT04326920). The SARPAC study is the first randomized, controlled clinical trial to assess the benefits of Leukine via inhalation in the treatment of COVID-19. In May, Singapore General Hospital also initiated a study of intravenous Leukine in COVID-19 patients (NCT04400929).
Leukine is FDA-approved for the treatment of acute radiation syndrome (ARS) and is held in the Strategic National Stockpile.