Methods and compositions for treating RNA viral infections
Inventors
NICOLA, George • Haders, Daniel
Assignees
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Abstract
Methods and compositions for treating RNA viral infections, including behavior symptoms of the RNA viral infections, are disclosed herein. Also disclosed are methods and compositions for reducing the progression of clinical complications associated with RNA viral infections. The methods, for example, can include administering pharmaceutical compositions or analogues thereof to a patient in need. One or more additional therapeutic agents can also be administered to the patient in the disclosed methods.
Core Innovation
The patent describes methods and pharmaceutical compositions for preventing, delaying, or treating RNA viral infections, with emphasis on coronaviruses including COVID-19/SARS-CoV-2. The approach involves administering to a subject in need thereof a composition comprising pipendoxifene, or a pharmaceutically acceptable salt, ester, solvate, stereoisomer, or tautomer thereof, wherein the administration treats the infection or the disease.
The patent further describes pharmaceutical composition embodiments that include one or more pharmaceutically acceptable excipients. Documented discussion includes computational prediction of receptor binding and experimental validation by binding and cellular assays, supporting lung-focused efficacy readouts such as reduced viral titer, neutrophil density, total necrotized cell count, and total protein level.
The invention also relates to antiviral development for compounds pipendoxifene and berzosertib against SARS-CoV-2. It states that berzosertib targets 3CLpro and pipendoxifene targets RdRp, and it discusses in vivo validation using an Ad-hACE2/SARS-CoV-2 mouse model and Syrian hamsters for PK, biodistribution, and repeat-dosing efficacy.
Claims Coverage
The provided material includes one independent claim and multiple dependent claims. The central inventive core is administering a composition containing pipendoxifene, or a pharmaceutically acceptable form, to treat a SARS-CoV-2 infection or disease in a subject in need thereof.
Pipendoxifene treatment of SARS-CoV-2 infection or disease
A method for treating an infection or a disease caused by a coronavirus by administering to a subject in need thereof a composition comprising a compound or a pharmaceutically acceptable salt, ester, solvate, stereoisomer, or tautomer thereof, wherein the compound is pipendoxifene and the coronavirus is SARS-CoV-2.
Therapeutically effective amount administration
The method further comprises administering the composition to the subject where the composition comprises a therapeutically effective amount of the compound.
Pharmaceutical composition with pharmaceutically acceptable excipients
The method further comprises administering a pharmaceutical composition that includes the compound and one or more pharmaceutically acceptable excipients.
Administration via specified routes
The method is carried out by administering the composition to a subject via intravenous, nasal, pulmonary, oral, parenteral, or nebulization routes.
Reduction of viral titer as a before/after readout
The method further includes measuring the viral titer of a coronavirus in the subject before and/or after administering the composition, where administration reduces the coronavirus viral titer compared to before administration.
Reduction of total necrotized cell count in lungs
The method further includes measuring the total necrotized cell count in a subject’s lungs and administering the composition to reduce that count compared to before administration.
Across the dependent refinements, the claim coverage centers on pipendoxifene administration for SARS-CoV-2 infection or disease, with added limitations covering therapeutically effective amount, pharmaceutical excipients, specified administration routes, and lung-based efficacy reductions measured by viral titer and total necrotized cell count.
Stated Advantages
Treats an infection or disease caused by a coronavirus when the coronavirus is SARS-CoV-2.
Reduces viral titer in the subject compared to before administration.
Reduces total necrotized cell count in the subject’s lungs compared to before administration.
Documented Applications
Preventing, delaying, or treating RNA viral infections, particularly coronavirus infections including COVID-19/SARS-CoV-2.
Treatment of an infection or disease caused by SARS-CoV-2 in a subject in need thereof.
Lung-focused efficacy assessment in the subject using readouts such as viral titer and total necrotized cell count.
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