Shifa Launches with Seed Financing to Address Cardiovascular Disease by Developing Orally Bioavailable Drugs for the Treatment of Dyslipidemia

- Collaboration with Xontogeny provides funding and key advisory support for early development -

MALVERN, Pa.--(BUSINESS WIRE)--#Cardiovascular--Shifa Biomedical Corporation (Shifa), a drug discovery company developing an oral small molecule PCSK9/low density lipoprotein-cholesterol receptor (LDLR) antagonist, P-21, to treat dyslipidemia, today announced their launch with a seed investment from Xontogeny, LLC to advance their lead program through IND-enabling research.

“We are excited to announce our collaboration with Shifa to address the unmet need for oral drugs that can treat dyslipidemia without the need for injections,” said Chris Garabedian, Founder, Chairman and Chief Executive Officer of Xontogeny. “The expertise of our team at Xontogeny complements that of the team at Shifa, and we are aligned on the key milestones we plan to achieve with this seed investment.”

Dyslipidemia refers to the presence of an abnormal level of lipids, cholesterol and fat, in the blood; such lipid disorders are the major contributor of premature morbidity and mortality from heart disease. Intervention with drugs to reduce LDL-cholesterol (LDL-C) through modulation of the LDLR degradation pathway by inhibiting the critical regulatory protein known as PCSK9 can decrease the risk of subsequent cardiovascular events. Shifa’s lead molecule, P-21, acts as a PCSK9/LDLR-antagonist to modulate the degradation of the LDLR in the liver, thereby regulating cholesterol homeostasis. With no orally bioavailable anti-PCSK9 drug having been FDA approved, P-21 shows promise as a potential new drug to treat hypercholesterolemic patients without the need for injections.

“It is with great enthusiasm that we begin this partnership with the team at Xontogeny to advance our lead compound through preclinical activities and prepare us for IND submission and clinical development,” said Sherin Abdel-Meguid, Founder and President of Shifa. “This seed investment will enable us to rapidly advance our drug product with efficient capital deployment and execute a successful development program. This is especially important in our goal to bring P-21 to patients as a potentially promising non-injectable treatment to address cardiovascular diseases.”

Having high blood cholesterol raises the risk for heart disease, the leading cause of death, and for stroke, the fifth leading cause of death. High total cholesterol (≥ 240 mg/dL) doubles the risk of heart disease, including heart attack. Plaques formed by cholesterol buildup can restrict blood flow to the brain and can cause a stroke. Intervention with drugs to reduce LDL-C has proven to decrease the risk of subsequent cardiovascular events, including mortality. However, a significant number of patients are either unresponsive or experience concerning side effects with current treatment options.

In addition to Sherin Abdel-Meguid as President, the Shifa management team includes Nabil Elshourbagy and Harold Meyers as Vice Presidents. The Board of Directors will be comprised of Chris Garabedian, CEO of Xontogeny, Gianna Hoffman-Luca, Senior Associate at Xontogeny, Shaker Mousa, Professor and Chairman at Albany College of Pharmacy and Health Sciences, and Sherin Abdel-Meguid, President of Shifa.

About P-21

P-21 is an orally bioavailable, small molecule that interferes with the function of PCSK9. This lead compound lowers LDL-C by about 90% in mice fed high-fat diet when the mice are given 30 mg/kg daily doses of the compound for two weeks. It is as potent as the monoclonal antibody, but it is orally bioavailable instead of injectable. P-21 was identified through Shifa’s proprietary technology to develop compounds that antagonize the PCSK9/LDLR interaction. The approach utilizes virtual screening of millions of compounds by docking at the PCSK9 site where LDLR binds, followed by in vitro validations, lead optimization, formulation optimization with concomitant in vivo testing to arrive at selection of P-21.

About Shifa Biomedical Corporation

Shifa Biomedical Corporation (Shifa) is a drug discovery company in Malvern Pennsylvania. It is a privately held biopharmaceutical company dedicated to the cost-effective development of drugs for the treatment of cardiovascular disease. Incorporated in 2006, Shifa has recognized expertise for the discovery of small molecule drugs, including pharmaceutical experience guided by biochemical, cell-based, and virtual screening. Shifa scientists exploit molecular biology, biochemistry, crystallography and medicinal, computational and combinatorial chemistry. Shifa is led by a highly-experienced team of scientists with extensive expertise in early-stage drug discovery. For more information, please visit: www.shifabiomedical.com.

About Xontogeny, LLC

Based in Boston, MA, Xontogeny seeks to accelerate the development of life science technologies by providing entrepreneurs with funding options as well as the leadership, strategic guidance and operational support necessary to increase the probability of success in early drug and technology development. Through a differentiated approach, the Xontogeny team partners with founding scientists and entrepreneurs to support their vision while allowing a more efficient development model that benefits company founders and early equity holders. For more information visit www.xontogeny.com.

Forward-Looking Statements

This press release contains “forward-looking statements” concerning the development of Shifa products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Shifa undertakes no obligation to update any forward-looking statements for any reason.

Corporate:
Sherin S. Abdel-Meguid, Ph.D.
Shifa Biomedical
sherin.s.abdel-meguid@shifabiomedical.com

Media:
Katie Gallagher
LaVoie Health Science
kgallagher@lavoiehealthscience.com
+1 617-792-3937

Katherine Marriott
LaVoie Health Science
kmarriott@lavoiehealthscience.com
+1 617-865-0049

Investors:
Fred Callori
Xontogeny, LLC
fred@xontogeny.com
+1 857-891-0017