Selva to Present Preclinical Data at ASV 2021 Demonstrating Prophylactic and Therapeutic Oral Dosing of SLV213 for COVID-19 Protected Lungs from SARS-CoV-2-Induced Damage

    • 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.

About SLV213

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.

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

 

 

Selva Announces SLV213, a Potential Oral COVID-19 Treatment, Has Broad Activity Against SARS-CoV-2 Variants of Concern

As an oral small molecule drug that inhibits a host protein to inhibit viral entry, SLV213 has potent activity against SARS-CoV-2 mutations and can be easily administered in any setting

SAN DIEGO, June 9, 2021 — Selva Therapeutics, Inc. (“Selva”) announced that its antiviral drug candidate SLV213 has been shown to be effective against three prominent variants of SARS-CoV-2 in a preclinical study. Previously reported preclinical studies in cell systems showed potent antiviral effect against the Washington isolate (the original strain) of SARS-CoV-2. In the follow-up study announced today, SLV213 has been shown to be equipotent against current major variants of concern, including variants from the UK (B.1.1.7 or Alpha), South Africa (B.1.351 or Beta), and Brazil (P.1 or Gamma).

“No loss of potency was found and equal activity against all variants was determined,” explained Felix Frueh, Ph.D., Chief Scientific Officer of Selva. “Because SLV213 targets a human protein necessary for the activation of the viral spike protein, we expect that SLV213 will remain equally efficacious against the Delta variant from India (B.1.167), and future variants of concern.”

Currently in clinical development as a potential treatment for COVID-19, SLV213, a novel, oral antiviral, is a cysteine protease inhibitor that targets cathepsin-L, a human protease involved in the cell entry pathway utilized by SARS-CoV-2 and other viruses. SLV213 has demonstrated activity against SARS-CoV-2 in vitro and in vivo and completed a Phase 1 clinical trial for safety. The drug candidate is ready to enter a Phase 2 clinical trial for outpatient antiviral treatment of COVID-19 patients.

“Infectious disease experts and public health officials have been sounding the alarm that we still urgently need oral therapies that can be given to newly-diagnosed patients to prevent hospitalization,” said Ted Daley, CEO of Selva. “As an oral antiviral, SLV213 has the potential to fill a critical gap in the treatment landscape for COVID-19. Presently there are no FDA-approved oral antiviral therapies that can be administered to non-hospitalized COVID-19 patients.”

Selva previously reported that SLV213 successfully completed a Phase 1 ascending oral dose clinical trial in healthy subjects. In that study, SLV213 was shown to be safe and well-tolerated at all dose levels tested. In preclinical studies in a non-human primate model of COVID-19, SLV213 demonstrated dose-dependent lung protection and reductions in viral load in treated animals compared to non-treated controls.

“SLV213 is an ideal candidate for patients who may only have mild or moderate COVID-19 symptoms, but still are at risk of progressing to hospitalization,” added Ken Krantz, M.D., Ph.D., Chief Medical Officer at Selva. “We believe that we can potentially prevent such hospitalizations and ease the suffering and burden caused by SARS-CoV-2 infections significantly. We plan to take a next step to demonstrating this in our planned Phase 2 clinical trial.”

About SLV213

SLV213 is a novel, orally available, small molecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry. 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, +1.858.344.8091

UC San Diego News: Experimental Therapy for Parasitic Heart Disease May Also Help Stop COVID-19

By blocking human enzyme cathepsin L, chemical inhibitor K777 reduces coronavirus’ ability to infect cell lines; clinical trials are underway

James McKerrow, MD, PhD, dean of the Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, has long studied neglected tropical diseases — chronic and disabling parasitic infections that primarily affect poor and underserved communities in developing nations. They’re called “neglected” because there is little financial incentive for pharmaceutical companies to develop therapies for them.

One of these neglected diseases is Chagas disease, the leading cause of heart failure in Latin America, which is spread by “kissing bugs” carrying the parasite Trypanosoma cruzi. These parasites produce an enzyme called cruzain that helps them replicate and evade the human immune system. McKerrow’s research team looks for inhibitors of cruzain — small molecules that might form the basis for new anti-parasitic medicines. One particularly effective cruzain inhibitor is called K777.

Then, in the spring of 2020, the COVID-19 pandemic began to sweep through the United States. Researchers quickly reported that SARS-CoV-2, the coronavirus that causes COVID-19, can’t dock on and infect human cells unless a human enzyme called cathepsin L cleaves the virus’ spike protein.

And it just so happens that cathepsin L looks and acts a lot like cruzain.

In a study published March 31, 2021 by ACS Chemical Biology, McKerrow and team show that low concentrations of K777 inhibit cathepsin L can reduce SARS-CoV-2’s ability to infect four host cell lines, without harming the cells.

Read more on UC San Diego’s News. 

Learn more about Selva’s cathepsin L inhibitor, SLV213, currently in clinical trials.

Selva Therapeutics Announces Successful Completion of Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Preclinical studies in nonhuman primates suggest SLV213 has the potential to be effective for therapeutic and prophylactic use

SAN DIEGO, February 2, 2021 — Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19. The company plans to rapidly advance SLV213 into a Phase 2 study in non-hospitalized COVID-19 patients. SLV213 is a small molecule drug candidate that inhibits cathepsin L, a human cysteine protease found in lung and other cells, to block viral entry. SLV213 has been shown to have broad antiviral activity against coronaviruses (including SARS-CoV-2), Ebola viruses, and paramyxoviruses. Because SLV213 inhibits a host protein to block viral entry, it has the potential to retain effectiveness and avoid resistance against viral mutations 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 Phase 1 study was a randomized, placebo-controlled, double-blinded study conducted in healthy volunteers. No dose limiting toxicity was reported in all dose groups tested, suggesting that SLV213 is safe for further clinical development. Pharmacokinetic profiles indicate a dose-dependent increase in SLV213 plasma levels and compatibility with twice daily dosing.

“We successfully completed our Phase 1 study with no dose-limiting toxicity,” said Ken Krantz M.D., Ph.D., Chief Medical Officer of Selva Therapeutics. “This positive outcome, which is further supported by our in vitro and in vivo data that demonstrate the activity of SLV213 as a potent antiviral therapeutic, allows Selva to move forward with testing SLV213 in a Phase 2 study in early COVID-19 patients.”

In addition to demonstrating the safety of SLV213, Phase 1 data also demonstrate that SLV213, when administered orally, achieves plasma levels expected to be efficacious based on primate studies. In preclinical studies in nonhuman primates (NHPs) in both prophylactic and therapeutic settings, SLV213 was shown to protect against lung damage infected with SARS-CoV-2, compared to untreated controls. Lung weights of NHPs treated with SLV213 remained normal in both settings at approximately 0.5% of total body weight, whereas the lung weights of control animals increased up to two-fold. The increased lung weights indicate severe inflammation and edema, which was confirmed by histopathological analyses.

“As an oral small molecule drug with broad antiviral activity, SLV213 could be a valuable treatment that retains activity against SARS-CoV-2 mutations and can be easily administered in any setting,” said Felix Frueh, Ph.D., Selva’s Chief Scientific Officer. “Furthermore, additional preclinical data suggest SLV213 could be used as a prophylactic treatment.”

Selva’s CEO, Ted Daley added, “Completing Phase 1 is an important milestone for our program and we’re excited to proceed into patient trials.”

About SLV213

SLV213 is a novel, orally available, small molecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry. 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, +1.858.344.8091

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