Indian American Salim Shah’s Sarfez Pharmaceuticals to begin clinical trials for new heart failure drug early next year

Salim Shah
Salim Shah

Sarfez gets ‘Notice of Allowance’ from USPTO for its patent application.

Sarfez Pharmaceuticals, founded by Indian American Salim Shah, has received a Notice of Allowance from the US Patent and Trade Office on its patent application for a new drug to treat heart failure, the company said in a press release.

Sarfez, a pharmaceutical research and development company based in Vienna, VA, is developing a fixed-dose combination of torsemide and a sodium glucose linked transport-2 (SGLT2) inhibitor, dapagliflozin, for the treatment of heart failure and related hospitalizations and re-admissions.

The company is scheduled to begin clinical trials for the drug early next year.

As the American Bazaar reported in July, SoanzXR, a new drug developed by Sarfez that would provide a new treatment option to people suffering from heart failure, is currently awaiting approval from the US Food and Drug Administration. It is a once-a-day extended release formulation of torsemide, which will effectively reduce volume overload and blood pressure.

Torasemide is used to treat high blood pressure and fluid overload because of heart failure, kidney disease and liver disease. It is the only loop diuretic shown to effectively lower high blood pressure, even with low doses.

Sarfez’s latest patent application, titled “Controlled-Release Formulations Comprising Torsemide,” covers the combination of extended release torsemide and an immediate release formulation of a SGLT-2 inhibitor such as dapagliflozin, it said in the release. The application covers both a composition matter/formulation and a method of treatment for the new combination, designed to improve results over solo SGLT2 therapy for heart failure treatments.

“We are pleased by the USPTO’s positive response to our patent application covering a new composition of matter and a method of treatment for heart failure,” said Shah, who is also the Chairman of Sarfez. “This is an important step in the development process for our fixed-dose combination of extended release torsemide and dapagliflozin. Sarfez Pharmaceuticals is committed to creating new drug therapies designed to improve patient outputs at a reasonable price.”

The Sarfez release said the new drug is a fixed-dose “combination of dapagliflozin (SGLT-2 inhibitor) and the company’s proprietary formulation of extended release torsemide” for treating heart failure.

“SGLT-2 inhibitors block kidney glucose reabsorption and allow glucose excretion in urine, reducing the level of glucose in the blood,” the release said. “Several SGLT-2 inhibitors are approved by the FDA as an adjunct therapy for the treatment of diabetes, but newly published data from several multi-center clinical studies have shown their additional benefits in heart failure patients, specifically in reducing readmission and hospitalization rates for heart failure. Co-administration of a loop diuretic further enhances the effects of SGLT-2 inhibitors. These additive effects of SGLT-2 inhibitors and loop diuretics come from their synergistic effects of reducing glucose and sodium reabsorption, respectively.”

Heart failure occurs when the heart cannot pump enough blood and oxygen to support other organs in the body. It affects nearly 1.8 percent of the US population, or about 5.7 million Americans, according to the Centers for Disease Control and Prevention. More than half a million new heart failure cases are diagnosed each year.

CDC says about half of people who develop heart failure die within five years of diagnosis and it costs an estimated $30.7 billion each year.

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