12 November 2020 - - US-based biotechnology company Selva Therapeutics, Inc.  has received US Food and Drug Administration clearance of an Investigational New Drug application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study, the company said.

Selva also announced preclinical data demonstrating in several host cell models that SLV213 inhibits SARS-CoV-2 infection by blocking the human host cell cysteine protease called cathepsin L.

Viruses work by infecting host cells and hijacking the cell's replication machinery. A (spike) protein present on the viral envelope must bind to a receptor on the surface of the host cell and be activated in order to enter the cell.

This activation is mediated by a human or host cysteine protease, cathepsin L, found in lung and other cells.

The recently disclosed data show that SLV213 exerts its antiviral activity by blocking cathepsin L, thereby preventing the activation of the viral spike protein and blocking viral entry into these cells.

SLV213 was shown to inhibit SARS-CoV-2 infection at nanomolar efficacy in multiple types of human and monkey cells.

SLV213 is a novel, orally available, small molecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry.

While SLV213 can be dosed orally or intravenously, Selva is first advancing it as an oral drug candidate for COVID-19.

There are many advantages to an oral therapeutic, including the ability to treat patients in an outpatient setting, a preferred treatment for mild to moderate and asymptomatic patients and for use as a prophylactic.

In addition, SLV213 potentially has broad antiviral activity against coronaviruses, Ebola viruses, and paramyxoviruses, including Nipah virus.

It also has completed preclinical development as a potential therapy against Chagas disease, a parasitic disease endemic to South and Central America and spreading into the southern United States.

SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.

Selva Therapeutics is a privately held biotechnology company dedicated to the development of therapeutics for infectious diseases.

By rapidly developing SLV213 for COVID-19, Selva Therapeutics intends to bring a valuable treatment to the market that has the potential to fight multiple life-threatening infectious diseases.