Use of rigosertib to treat RNA virus infections

Inventors

Reddy, Premkumar • White, Kris • Reddy, M.V. Ramana • Garcia-Sastre, Adolfo

Assignees

Icahn School of Medicine at Mount Sinai

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Publication Number

US-12616671-B2

Patent

Publication Date

2026-05-05

Expiration Date


Abstract

Provided herein are methods for treating a virus (e.g,. an RNA virus, such as a SARS-CoV-2) infection or a disease associated therewith (e.g., COVID-19) comprising administering Rigosertib or a composition thereof to a subject (e.g., a human subject).

Core Innovation

Rigosertib (ON01910.Na), a small-molecule RAS-mimetic, is disclosed for treating RNA virus infections by administering rigosertib alone or in effective amounts, including to a human subject in need thereof. The disclosure specifies treatment of a SARS-CoV-2 infection or COVID-19 and provides pharmaceutical compositions. It further includes prophylactic methods and describes multiple administration routes and oral and injectable formulations.

The disclosure describes outcome-related effects in a clinical-style framework, including reduced hospitalization, reduced mortality, and reduced viral titer. It also describes effects associated with COVID-19 symptoms such as fever, myalgia, cough, difficulty breathing, and fatigue, and mitigation of organ failure outcomes. Ordinal scale and need for invasive mechanical ventilation and oxygen supplementation are also referenced.

Example in vitro antiviral data are provided showing rigosertib inhibits SARS-CoV-2 replication in Vero E6 cells, with an IC50 of 16 nM. Comparative positive controls are described, including remdesivir with an IC50 of about 826 nM and hydroxychloroquine with an IC50 of about 733 nM. The disclosure further reports little or no cytotoxicity under tested conditions and includes kit embodiments and combination therapy.

Claims Coverage

The document provides one independent claim covering treatment of SARS-CoV-2 infection or COVID-19 by administering rigosertib, with dependent claims refining specific rigosertib dosage amounts and dosing frequency.

Administering rigosertib for SARS-CoV-2 infection or COVID-19 treatment

A method for treating a SARS-COV-2 infection or COVID-19 by administering to the subject an effective amount of Rigosertib to a human subject in need thereof.

Dosage amount options for rigosertib

The method of administering rigosertib includes administering a rigosertib dosage of 280 mg, 560 mg, 840 mg, or 1120 mg.

Dosing frequency of rigosertib

The method includes administering the rigosertib dosage once or twice per day, or once per day.

Overall, claim coverage centers on administering an effective amount of rigosertib to treat SARS-CoV-2 infection or COVID-19, with further inventive-feature refinements specifying particular rigosertib dosage amount options and dosing frequency.

Stated Advantages

Reduced hospitalization.

Reduced mortality.

Reduced viral titer.

Reduced COVID-19 symptom burden (including fever, myalgia, cough, difficulty breathing, and fatigue).

Reduced organ failure outcomes.

Little or no cytotoxicity reported in the disclosed example.

Documented Applications

Treatment of a SARS-COV-2 infection or COVID-19 in a human subject in need thereof.

Prophylactic methods for RNA virus infections (including SARS-CoV-2/COVID-19 context as disclosed).

Combination therapy embodiments involving rigosertib (as disclosed).

Pharmaceutical compositions and kit embodiments for rigosertib (as disclosed).

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