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Shifa Biomedical Corporation Presents Preclinical Data on P-21, a Novel Orally Active PSCK9 Antagonist, at the American Heart Association (AHA) Meeting, Scientific Sessions 2018

November 12, 2018

CHICAGO, Nov. 12, 2018 (GLOBE NEWSWIRE) -- Shifa Biomedical Corporation (Shifa), a drug discovery biopharmaceutical company focused on developing novel agents to treat cardiovascular disease and hypercholesteremia, today announced exciting preclinical data involving the company’s pre-clinical candidate, P-21, which interferes with the interaction between PCSK9 and the LDL receptor (LDLR). The presentation is part of the American Heart Association Scientific Sessions being held November 10th to 12th in Chicago.

Details of the presentation are as follows:

Abstract Title: Development of Protease Proprotein Convertase Subtilisin-Like Kexin Type 9 AntagonistsSession Title: Russell Ross Memorial LectureSession Number: AT.AOS.04 Abstract Control Number: 14810Presentation Number: 121 Date/Time: Monday, November 12, 2018. 11:30 AM – 11:40AM CSTLocation: S105abc Presenter: Nabil A Elshourbagy, Vice President, Shifa Biomedical Corporation.

“We are tremendously excited about the recent data obtained with P-21, our small molecule PSCK9 antagonist,” said Sherin Abdel-Meguid, President of Shifa. “We have been conducting research in this area for several years and our in vitro data was encouraging. However, the LDL reduction seen in mice with P-21 is outstanding, comparable to that seen with the approved PCSK9 monoclonal antibodies. This strong data will enable us to seek partners to rapidly advance P-21 toward an IND filing and our first trial in humans.”

Shifa Biomedical successfully identified a potent orally bioavailable small molecule PCSK9 antagonist. This lead molecule (P-21) was identified through virtual screening of a million compounds and extensively validated through our in vitro as well as our functional cell-based assays. P-21 exhibited a concentration-dependent inhibition of the PCSK9/LDLR interaction with an IC50 in the nanomolar range, an increase in the level of LDLR in recombinant cell-based assays, and a significant increase in the fluorescently labeled DiI-LDL uptake in the nanomolar range.

In vivo animal studies showed that oral administration of P-21 at doses of 1, 3, 10 and 30 mg/kg to mice fed a high-fat diet resulted in up to approximately 90% lowering of LDL-cholesterol (LDL-C) at the completion of the two week study period. The LDL-C lowering effect of P-21 is comparable to the marketed monoclonal antibodies; Repatha (Amgen) and Praluent (Regeneron/Sanofi). P-21 is safe, as no liability issues were observed in vitro, in multiple cell based assays or in the vivo animal model.

About Shifa Biomedical Corp.

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, specifically hyperlipidemia. Incorporated in 2006, Shifa has recognized expertise in the discovery of small molecule drugs, including that guided by biochemical, cell-based, and virtual screening. Shifa scientists exploited molecular biology, biochemistry, crystallography and medicinal, computational and combinatorial chemistry to discover and patent P-21. Shifa is led by a highly-experienced team of scientists with extensive expertise in early stage drug discovery. Shifa Biomedical is currently seeking investors and pharmaceutical partners to advance P-21 to the IND filing and first in human trials.

More information about cardiovascular disease, Shifa Biomedical Corp. and P-21 can be found on the Shifa website: http://shifabiomedical.com/index.html

Media Contact at AHA Nabil A Elshourbagy, Vice President, Shifa Biomedical nabil.elshourbagy@shifabiomedical.com Ph# 610-613-9629

Investor Contact

Ihor Terleckyj, Ph.D.VP, Commercial Strategy & Product Development ihor@shifabiomedical.com Ph# (973)479-7110

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