Sarfez Completes Formulation Development, Plans Clinical Trials for Combination of Loop Diuretic and SGLT-2 Inhibitor

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USPTO Issues ‘Notice of Allowance’ for Company’s Patent Application, Boosts Development of New Treatments for Patients with Heart Failure

“This is an important step in the development process for our fixed-dose combination of extended release torsemide and dapagliflozin.” said Salim Shah, PhD, JD, Founder and Chairman

Sarfez Pharmaceuticals has received a Notice of Allowance from the U.S. Patent and Trade Office (USPTO) regarding the patent application titled “Controlled-Release Formulations Comprising Torsemide.” The company is developing a fixed-dose combination of torsemide and a sodium glucose linked transport-2 (SGLT2) inhibitor, dapagliflozin; for the treatment of heart failure (HF) and to reduce HF-related hospitalizations and readmissions. The company has completed formulation development work and will begin conducting clinical trials in first quarter of 2020.

Heart failure affects about 5.7 million people in the U.S., making up to 1.8% of the population. There are 550,000 new HF cases diagnosed each year, with 60% of new patients over the age of 70. Today, diuretics constitute a key drug therapy to treat HF. However, most loop diuretics suffer from defects and complications, including electrolyte and metabolic disturbances and a reduction in glomerular filtration rate, which is already reduced in most HF patients. Another class defect of loop diuretics is the short duration of action, 2-4 hours after dosing, which contributes to their inadequate effectiveness.

Sarfez’s latest patent application covers the combination of extended release torsemide and an immediate release formulation of a SGLT-2 inhibitor such as dapagliflozin. The patent 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 HF treatments.

Torsemide is a high-ceiling loop diuretic with relatively longer half-life and higher but less variable bioavailability compared to the most commonly used loop diuretic, furosemide. Torsemide is approved for the treatment of edema in patients with HF, chronic kidney disease, liver cirrhosis, and arterial hypertension (AH). It is the only loop diuretic shown to effectively lower high blood pressure, even with low doses.

SGLT-2 inhibitors block kidney glucose reabsorption and allow glucose excretion in urine, reducing the level of glucose in the blood. 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. Based on these scientific principles, Sarfez Pharmaceuticals has developed a fixed-dose combination of dapagliflozin (SGLT-2 inhibitor) and the company’s proprietary formulation of extended release torsemide (loop diuretic) for heart failure treatment.

“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 Salim Shah, PhD, JD, Founder and Chairman, Sarfez Pharmaceuticals. “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.”

About Sarfez

Sarfez Pharmaceuticals, headquartered in Vienna, VA is a pharmaceutical research and development company focused on improving existing drugs to provide better treatment options for cardio-renal diseases. Sarfez Pharmaceuticals is dedicated to creating better treatment options and reducing patient expenses by improving existing cardiovascular drugs and offering them at a reasonable cost and with greater price transparency.

Forward-looking Statement

Some statements such as FDA review and prospective approval are forward-looking. For these statements, we claim we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual statements to differ materially are the following: while we continue to work with the FDA, there is no assurance that we will answer all the questions to the FDA’s satisfaction, that the FDA will ultimately approve the NDA by the expected date. Any forward-looking statements contained in this press release speak only as of the date hereof, and Sarfez expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Salim Shah
@SarfezP
since: 09/2019
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