- Additional in vitro data to be presented at ASV 2021 show SLV213 significantly enhances the efficacy of remdesivir and molnupiravir, two nucleoside analogs in development to treat COVID-19 as specific, direct-acting antivirals for SARS-CoV-2
- Selva has also validated that SLV213 is highly potent against SARS-CoV-2 and three variants of concern, and, as a broad, host-acting antiviral, SLV213 is expected to have equipotent activity against all current and future SARS-CoV-2 variants
- A Phase 1 clinical trial of SLV213 has been successfully completed, and SLV213 is Phase 2 ready for a COVID-19 outpatient study
SAN DIEGO, July 19, 2021 — Selva Therapeutics, Inc. (“Selva”) announced new preclinical data demonstrating SLV213, when given as a prophylactic or a treatment for SARS-CoV-2 infection, protects against SARS-CoV-2-induced diffuse alveolar damage (DAD), which is associated with the early stages of acute respiratory distress syndrome (ARDS). Additional in vitro data show that SLV213 greatly enhances the efficacy of remdesivir and molnupiravir, two drugs that target the virus. These data will be presented at the 40th Annual Meeting of the American Society of Virology (ASV) taking place virtually July 19-23.
“These preclinical data show that not only is SLV213 highly potent as a monotherapy before and after SARS-CoV-2 infection to potentially prevent severe COVID-19 and hospitalization but it also synergizes and complements the activity of remdesivir and molnupiravir,” said Ted Daley, CEO of Selva. “As one of the few, if not only, oral host-acting antivirals in development that can block viral entry and retain effectiveness against SARS-CoV-2 variants, we believe there is great urgency to advance SLV213 in clinical trials as a prophylactic and treatment for COVID-19 to prevent hospitalization and progression to severe disease.”
Remdesivir and molnupiravir act once the virus is inside of the cell, starving it of the nucleic acids required for it to replicate. Similar to monoclonal antibodies, SLV-213 inhibits the activation of the spike protein required for SARS-CoV-2 to infect a cell. Whereas monoclonal antibodies and nucleoside analogs act specifically on the virus, SLV213 blocks the human cell entry pathway to broadly be effective against SARS-CoV-2 and its variants as well as other coronaviruses and viruses, including Ebola and Nipah. As an oral host-acting antiviral, SLV213 has the potential to be used together with direct-acting antivirals or alone as a prophylactic or outpatient treatment, a preferred setting for mild to moderate and asymptomatic patients.
“It’s clear that we need drugs that are effective no matter what SARS-CoV-2 variant is circulating,” added Felix Frueh, Ph.D., Chief Scientific Officer of Selva. “Because SLV213 acts on the host cell to prevent viral entry, we expect that SLV213 will remain equally effective against the Delta variant and future SARS-CoV-2 variants of concern. Furthermore, SLV213 is highly potent as a single oral agent and can enhance the efficacy of direct-acting antivirals, such as monoclonal antibodies and nucleoside analogs.”
At ASV 2021, Selva will present data showing SLV213 protected lungs against damage when given as a therapeutic or a prophylactic in a nonhuman primate (NHP) model, compared to untreated controls. In additional preclinical studies in a NHP model, SLV213 demonstrated dose-dependent lung protection and reductions in viral load in treated animals compared to non-treated controls. Furthermore, previously disclosed preclinical data show SLV213 is equipotent against prominent SARS-CoV-2 variants: Alpha (B.1.1.7 or UK), Beta (B.1.351 or South Africa), and Gamma (P.1 or Brazil). Selva successfully completed a Phase 1 ascending oral dose clinical trial of SLV213 in healthy subjects. In that study, SLV213 was shown to be safe and well-tolerated at all dose levels tested. SLV213 is ready to enter a Phase 2 clinical trial for outpatient antiviral treatment of COVID-19 patients.
“The COVID-19 treatment landscape is dominated by direct-acting antivirals, leaving us susceptible to SARS-CoV-2 variants,” said Ken Krantz, M.D., Ph.D., Chief Medical Officer at Selva. “We’ve demonstrated that SLV213, as a host-acting antiviral, provides a formidable approach to not only fight SARS-CoV-2 but also protect against other life-threatening infectious disease.”
Dr. Frueh will present the data at ASV 2021 in two oral presentations taking place Wednesday, July 21 at 7:30 pm and 8:45 pm EDT, respectively:
- W27-7: SLV213, a New, Orally Available Cathepsin L Inhibitor for Treatment of Patients with COVID-19 Shows Protection of Lungs Against SARS-CoV-2-Induced Diffuse Alveolar Damage (DAD)
- W27-12: Combination of Remdesivir with SLV213, a New, Orally Available Cathepsin L Inhibitor for Treatment of Patients with COVID-19 Significantly Enhances Remdesivir Response In Vitro
The data is also available on biorxiv: https://doi.org/10.1101/2021.07.20.453127.
SLV213 is a novel, orally available, small molecule antiviral investigational drug that inhibits human host cell cysteine proteases to block viral entry. In addition to being developed as a treatment for SARS-CoV-2 (COVID-19), SLV213 has demonstrated in vitro broad antiviral activity against coronaviruses, Ebola viruses, and Nipah viruses. SLV213 has also 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.
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