Karyopharm's selinexor shows promising results in COVID-19 and Low LDH/DD

• Karyopharm Therapeutics (NASDAQ:KPTI) presents data from a Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19 at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19 taking place from October 6 - 8, 2020.
• While an interim analysis indicated that the trial was unlikely to meet its pre-specified primary endpoint, and has since been discontinued, the results demonstrated encouraging anti-viral and anti-inflammatory activity in an important subset of treated patients.
• The 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 lower than the 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).
• A significant reduction in 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.
• XPOVIO is an oral Selective Inhibitor of Nuclear Export compound. It functions by selectively binding to and inhibiting the nuclear export protein exportin 1.
• https://seekingalpha.com/news/3620100-karyopharms-selinexor-shows-promising-results-in-covidminus-19-and-low-ldh-dd