Karyopharm Therapeutics (NASDAQ:KPTI) dosed the first patient in a Phase 2 clinical study evaluating low-dose oral selinexor in hospitalized patients with severe COVID-19.
Selinexor is designed to block XPO1, a cellular protein that is involved in both the replication of SARS-CoV-2 and in the body’s inflammatory response to the virus.
The global study is expected to enroll some 230 patients at sites in the U.S., Europe, and Israel. Patients will receive 20mg of selinexor orally, three times a week, for two weeks. The study’s primary endpoint is time to clinical improvement.
“This important milestone marks the first study of an XPO1 inhibitor in patients with severe viral infections,” Sharon Shacham, Karyopharm’s president and CSO, said in a statement.
“We remain highly encouraged by the potential anti-viral and anti-inflammatory activity of XPO1 inhibition with selinexor and look forward to working with the medical community of regulators, treating physicians and patients on advancing this important study as quickly as possible,” she added.
Selinexor, marketed as XPOVIO, is currently FDA-approved at higher doses as a treatment for patients with relapsed or refractory multiple myeloma.