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Serpin Pharma Receives FDA Approval for COVID-19 Clinical Investigation

Tuesday, July 28, 2020  
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Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients.

Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, "SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection."

Working with collaborators specializing in infectious disease, it was also found that SP16 significantly inhibited viral replication in COVID-19 infected cells. The dual functionality of SP16 drug against COVID19 in mitigating the "cytokine storm" and "out of control" systemic inflammation combined with antiviral activity, may afford SP16 drug a potentially higher therapeutic value to COVID 19 patients.

"We are delighted with the FDA decision to approve the IND allowing Serpin Pharma to move forward with a clinical investigation of SP16 for treatment of the COVID-19 disease," said Dr. Cohava Gelber, Chief Executive Officer, Serpin Pharma.

SP16 is a first-in-class drug that targets the LRP1 receptor, which regulates multiple internal signal transduction pathways and plays a critical role in regulating inflammation, cellular metabolism, and maintaining homeostasis, particularly in the lung. Unlike other inflammasome inhibitors that target NLRP to reduce IL1B and IL18 primarily, SP16 works upstream of the inflammasome, providing for complete inhibition of inflammatory cytokines and tissue repair.

Serpin Pharma is a private, clinical-stage company located in Prince William County’s Innovation Park, VA. SP16 is a short peptide derived from a SERPIN (Serine Protease Inhibitor) and it regulates innate immune responses (inflammasome), resolves inflammation by removing harmful surface debris and promotes healing. The company is currently conducting a phase IIa trial in Acute Myocardial Infarction (AMI) patients. SP16 is also in development for Eosinophilic Esophagitis (an orphan indication) and Diabetic peripheral neuropathy.


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