SAN DIEGO--(BUSINESS WIRE)--Selva Therapeutics, Inc. announced today that the company has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. 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 (CTSL).
“These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”
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.
“We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics. “Because SLV213 inhibits a host protein to block viral entry, it has the potential to retain effectiveness against viral mutations to avoid resistance and could be a highly potent therapy against a number of viruses, either as a single oral agent or in combination with direct acting antivirals.”
The research paper entitled, “A cysteine protease inhibitor blocks SARS-CoV-2 infection of human and monkey cells” is available as a preprint on bioRxiv: https://doi.org/10.1101/2020.10.23.347534.
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.
About 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. For more information, visit www.selvarx.com.