With dangerously high mortality rates among those COVID-19 patients with severe and critical cases, Washington University School of Medicine seek to study novel methods to quell aberrant hyperactivation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation and limit viral persistence and hence improving patient outcomes. Hence, the university recently partnered with Verastem Inc. to investigate a novel therapy called duvelisib manufactured by Verastem Oncology.
Called a pilot study of Duvelisib to combat COVID-19, this single group assignment, open label, pilot Phase II study will involve up to 25 participants to commence June 30, 2020 through July 31, 2021 with a study completion date December 31, 2021. The study protocol calls for the administration of Duvelisib 25mg twice daily for 10 days. The primary outcome measure of the study involves an assessment of overall survival as measured over a 28-day period. There are a number of secondary outcome measures which can be viewed at the source. Washington University School of Medicine’s lead investigator is John DiPersio.
Who is Verastem Oncology?
The makers of the drug duvelisib, Verastem Oncology focuses on tailored cancer solutions as they understand that not one size fits all in treatment approaches. The company’s pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including phosphoinositde-3-kinase (PI3K), focal adhesion kinase (FAK) and RAF/MEK inhibition. Their first FDA approved product is available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL).
The Study Drug
Also known as IPI-145, the drug was discovered by Intellikine, a company founded in September 2007 based on biochemistry research from the lab of Kevan Shokat at the University of California, San Francisco. By November 2106, the company Infinity exclusively licensed the worldwide rights to duvelisib to Verastem Oncology for little money compared to earlier deals—the deal included no upfront payment , a $6 million milestone for success in a phase III trial in chronic lymphocytic leukemia, a $22 million payment for an FDA approval and royalties. In 2019, Duvelisib received orphan drug designation in the United States for treatment of peripheral T-cell lymphoma (PTCL) .
John DiPersio, MD, PhD, Principal Investigator, Washington University School of Medicine
Erik Dubberke, MD, MSPH, Sub-Investigator, Washington University School of Medicine
Mark Fiala, MSW, Sub-Investigator, Washington University School of Medicine