Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Preclinical data show SLV213 is a potent inhibitor of SARS-CoV-2 infection

 SAN DIEGO, November 12, 2020 — 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

 About SLV213

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.

 

Media Contact: Jessica Yingling, Ph.D., Little Dog Communications, jessica@litldog.com

 

 

Selva Therapeutics Announces $3 Million Series A Financing to Advance a Novel Broad Spectrum Antiviral for Infectious Diseases, Including COVID-19

SLV213, a small molecule drug candidate, inhibits host cell cysteine proteases to block viral entry and has broad antiviral activity against coronaviruses,  bola  viruses, and paramyxoviruses

SAN DIEGO, July 21, 2020 — Selva Therapeutics, Inc. announced today that the company has raised $3 million in a Series A financing round from private investors. The proceeds of the financing will be used to rapidly advance SLV213 into clinical trials as a leading oral drug candidate for the treatment of COVID-19, the disease caused by SARS-CoV-2 infection. In addition to COVID-19, SLV213 has the potential to be a treatment for multiple infectious diseases caused by other coronaviruses such as SARS, but also Ebola viruses and Nipah virus, as well as Chagas disease, a parasitic disease endemic to South and Central America and spreading into the southern United States.

Foundational research established the broad and potent antiviral activity of SLV213 against a range of viruses by inhibiting host cell cysteine proteases. Selva has generated additional data that shows SLV213 is also highly potent against SARS-CoV-2. Furthermore, the company has completed preclinical IND-enabling safety studies and a pre-IND meeting with the FDA to ready SLV213 for clinical development.

“Based on compelling preclinical safety profile and efficacy data, indicating high potency against SARS-CoV-2, we are focused on accelerating the clinical development of SLV213 as an oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “The rapid development of SLV213 for COVID-19 can bring a valuable treatment to the market to meet the urgent need for COVID-19, as well as advance a pandemic preparedness drug with the potential to fight multiple life-threatening infectious diseases and protect global health.”

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 host cysteine protease, cathepsin L. SLV213 is designed to block cathepsin L, thereby preventing the activation of the viral spike protein and blocking viral entry into host cells.

“Antivirals that specifically target the virus can be highly effective but can become ineffective if the virus mutates and cannot be used broadly to treat other viral infections,” said James McKerrow, Ph.D., M.D., Distinguished Professor and Dean, Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego and scientific advisor, Selva Therapeutics. “Because SLV213 acts on the host cell to block viral entry, which is a conserved mechanism across many types of viruses, it has the potential to retain effectiveness against viral mutations and avoid resistance. It may also be a highly potent therapy against a number of viruses, either as a single oral agent or in combination with direct acting antivirals.”

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.

“The Series A investment supports the rapid entry of SVL213 into the clinic for COVID-19 treatment in Q3 2020,” said Series A investor and Selva Board of Directors member, Kenneth Kelley. “With the potential for non-dilutive grant funding as well as additional equity capital, the company could accelerate the speed of clinical development to advance a much-needed new antiviral therapy in the fight against COVID-19.”

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

About Selva Therapeutics

Selva Therapeutics is a privately held biotechnology company dedicated to the development of therapeutics for infectious diseases. The company’s lead drug candidate, SLV213, is an orally available small molecule novel antiviral therapy with activity against a broad range of viruses that threaten global health, including SARS-CoV-2, the virus causing COVID-19. In addition, SLV213 has activity against Ebola and Nipah viruses and has completed preclinical development as a potential therapy against Chagas disease. Selva is headquartered in San Diego. For more information, visit www.selvarx.com.

Media Contact: Jessica Yingling, Ph.D., Little Dog Communications, jessica@litldog.com, +1.858.344.8091