#KPTI announced its "oral presentation at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group (ISIRV-AVG) Virtual Conference on Therapeutics for COVID-19 taking place from October 6 - 8, 2020. The presentation will feature data from a Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19 (NCT04349098).
While an interim analysis indicated that the trial was unlikely to meet its pre-specified primary endpoint across the entire patient population studied, and has since been discontinued, the results demonstrated encouraging anti-viral and anti-inflammatory activity in an important subset of treated patients. The randomized, multi-center, placebo-controlled Phase 2 study was designed to assess the activity and safety of 20mg of selinexor given orally three times a week for two weeks, a dosing level significantly lower than the U.S. Food and Drug Administration (FDA) approved dose of selinexor, marketed as XPOVIO®, to treat patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma.
A post-hoc analysis of 66 patients with either baseline serum lactate dehydrogenase (LDH) ≤370 U/L or D-dimer ≤600 mcg/L FEU (Low LDH/DD) showed that treatment with selinexor (n=38) compared to placebo (n=28) was associated with a significantly higher percentage of patients discharged by Day 14 (78.9% vs 57.1%; p=0.029) with a trend towards superior ≥2-point improvement in the Ordinal Scale (OSI-2) on Day 14 (78.9% vs 64.3%; p=0.095). Additionally, a positive trend was observed in patients treated with selinexor to convert to a negative COVID-19 PCR test as compared to placebo (42.1% vs 28.6%; p=0.13) and a significant reduction in IL1-RA, IL-6, IL-7, IP-10, and TNF-a levels, measurements of inflammation, was also seen within eight days of selinexor treatment (p<0.05). Adverse events occurred in 63.2% of patients treated with selinexor and 51.9% of patients with placebo in the subset, with similar occurrences of deaths across the treatment arms (2 vs. 1). Blood levels of LDH and D-dimer are important prognostic markers for in-hospital mortality in patients admitted for COVID-19" (see press release HERE).
Details for the ISIRV-AVG oral presentation are as follows:
Title: Treatment of Severe COVID-19 with Low-Dose Selinexor: Demonstration of Anti-Viral and Anti-Inflammatory Activities in a Randomized, International, Multicenter, Placebo-Controlled Phase 2 Clinical Trial Presenter: George F. Geils, M.D., Roper St. Francis Healthcare Date: October 7, 2020; 10:50 EST
See our KPTI AmpCard to learn more.