Manassas-based Serpin Pharma has been notified by the U.S. Food and Drug Administration that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients.
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.
According to Dr. Larry Altstiel, acting chief medical officer for Serpin Pharma, SP16 reduces the production of inflammatory cytokines while sparing normal and protective immune function.
“It is effective in several animal models of acute inflammation, in particular, following a severe lung infection,” said Dr. Altstiel. “Therefore, its ability to inhibit excess cytokine production may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection."
In COVID-19 patients, the viral infection can lead to uncontrolled inflammation and acute lung injury, characterized by severe and quickly progressing lung damage. While working with collaborators specializing in infectious disease, Serpin Pharma also found that SP16 significantly inhibited viral replication in COVID-19 infected cells.
In mitigating the "cytokine storm" and "out of control" systemic inflammation combined with antiviral activity, SP16 may afford a potentially higher therapeutic value to COVID 19 patients.
"We are delighted with the FDA decision to approve the IND [Investigational New Drug Application] 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.
Established in 2011, Serpin Pharma specializes in the development of anti-inflammatory and immune modulating peptides with potential application in inflammatory, autoimmune diseases such as rheumatoid arthritis and diabetes.
The company is located in the Prince William Science Accelerator at Innovation Park, a premier life sciences incubation facility, which features nine fully built-out wet labs – the only commercially available wet lab space in Northern Virginia.
“Serpin Pharma’s work on the SP16 drug is an exciting development in the fight against COVID-19,” said Jeanine Lawson, Brentsville District Supervisor, Prince William Board of County Supervisors. “I’m so proud Serpin Pharma is part of our growing Life Sciences community here in Prince William County and I’m thrilled they can move forward with their clinical investigation.”