Biphenyl sulfonamide compounds for the treatment of kidney diseases or disorders
Inventors
Assignees
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Publication Number
US-10864197-B2
Publication Date
2020-12-15
Expiration Date
Abstract
Methods of treatment comprising administering a compound having structure (I), or a pharmaceutically acceptable salt thereof, or administering a pharmaceutical composition comprising the compound of structure (I) or pharmaceutically acceptable salt thereof, are provided.
Core Innovation
The patent relates to a method of treating Alport syndrome by administering to a subject in need thereof a pharmaceutical composition comprising a compound having structure (I), or a pharmaceutically acceptable salt thereof. The compound is described as a selective dual angiotensin II (AT1) and endothelin (ETa) receptor antagonist and as an active agent in kidney disease treatment.
The disclosed treatment is directed to kidney diseases/disorders, with particular emphasis on Alport syndrome and proteinuria. The method uses urine protein to creatinine (UP/C) as the treatment-relevant parameter, including achieving or maintaining a UP/C ratio at or below 1.5 g/g and achieving at least a 40% reduction in UP/C from baseline.
The method further includes administration periods of 8 weeks, 26 weeks, and 8 months, together with dosing and administration conditions for the compound having structure (I) or a pharmaceutically acceptable salt thereof. Additional conditions mentioned include dose escalation in which a subsequent dose is greater than an initial dose, a patient history of UP/C greater than 1.5 g/g, and measuring blood pressure before subsequent dosing.
Claims Coverage
Two independent claim themes are identified across the items: treatment of Alport syndrome with a pharmaceutical composition containing a compound having structure (I) or a pharmaceutically acceptable salt, and UP/C-based treatment outcomes. Dependent refinements repeatedly add specified dosing ranges, dose escalation, child weight limitation, and blood pressure measurement.
Method of treating Alport syndrome with structure (I) compound composition
Administering to a subject in need thereof a pharmaceutical composition comprising a compound having structure (I), or a pharmaceutically acceptable salt thereof.
UP/C threshold at or below 1.5 g/g
Achieving or maintaining a urine protein to creatinine (UP/C) ratio of less than or equal to 1.5 g/g.
Dose range of about 50 mg/day to about 1000 mg/day
Administering the compound having structure (I), or a pharmaceutically acceptable salt of it, in an amount ranging from about 50 mg/day to about 1000 mg/day.
Subsequent dose greater than initial dose
Administering the compound of structure (I), or a pharmaceutically acceptable salt, at an initial dose and then at a subsequent dose that is greater than the initial dose.
Child weighing less than 50 kg
Applying the method to a subject that is a child weighing less than 50 kg.
Measuring blood pressure before the next administration
Measuring the subject's blood pressure before the next administration.
Overall, the claims coverage centers on treating Alport syndrome using a pharmaceutical composition containing a compound having structure (I), or a pharmaceutically acceptable salt, with dependent refinements specifying UP/C control, dose range, dose escalation, child weight limitation, and blood pressure monitoring.
Stated Advantages
Reducing proteinuria as reflected by achieving, maintaining, or reducing urine protein to creatinine (UP/C) to at or below 1.5 g/g.
Achieving at least a 40% reduction in UP/C from baseline.
Targeting proteinuria outcomes over defined administration periods including 8 weeks, 26 weeks, and 8 months.
Documented Applications
Treatment of Alport syndrome via administering a pharmaceutical composition comprising a compound having structure (I) or a pharmaceutically acceptable salt.
Kidney diseases/disorders, including focal segmental glomerulosclerosis (FSGS), IgA nephropathy, and idiopathic membranous nephropathy.
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