SLV213 / Selva Therap - LARVOL DELTA

Safety Study of SLV213 for the Treatment of COVID-19. (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=36 ➔ 16 | Suspended ➔ Terminated; DMID unanimously arrived at a recommendation to terminate the study after study met cohort halting criteria.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

Safety Study of SLV213 for the Treatment of COVID-19. (clinicaltrials.gov) - P1 | N=36 | Suspended | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Suspended

Trial suspension • Infectious Disease • Novel Coronavirus Disease

A Single-dose Phase 1 Study With SLV213 Demonstrates Safety and Pharmacokinetics Enabling Investigation of a New Orally Available Cathepsin L Inhibitor for Treatment of Patients With Respiratory Diseases (ATS 2024) - "Pharmacokinetic profiles indicate a dose-dependent increase in plasma concentrations and compatibility with either once-daily or twice-daily dosing. SLV213 is a novel host-targeted antiviral that warrants clinical investigation for the treatment of COVID-19 and other viral diseases."

Clinical • P1 data • PK/PD data • Ebola Virus Disease • Hypotension • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CTSS

Safety Study of SLV213 for the Treatment of COVID-19. (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Safety Study of SLV213 for the Treatment of COVID-19. (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Nov 2023 ➔ Mar 2024

Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Safety Study of SLV213 for the Treatment of COVID-19. (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Infectious Disease • Novel Coronavirus Disease

SLV213 Treatment in Ambulatory COVID-19 Patients (clinicaltrials.gov) - P2a | N=81 | Not yet recruiting | Sponsor: Kenneth Krantz, MD, PhD | Trial completion date: Oct 2021 ➔ Jul 2024 | Trial primary completion date: Oct 2021 ➔ Jun 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

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 (Businesswire) - P1, N=NA; "Additional in vitro data show that SLV213 greatly enhances the efficacy of remdesivir and molnupiravir....SLV213 protected lungs against damage when given as a therapeutic or a prophylactic in a nonhuman primate (NHP) model, compared to untreated controls....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."

P1 data • Preclinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

Selva Announces SLV213, a Potential Oral COVID-19 Treatment, Has Broad Activity Against SARS-CoV-2 Variants of Concern (Businesswire) - "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....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)....'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'....'We plan to take a next step to demonstrating this in our planned Phase 2 clinical trial.'"

Preclinical • Infectious Disease • Novel Coronavirus Disease

A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 2a Study of SLV213 in Ambulatory Individuals Positive for COVID-19 (clinicaltrials.gov) - P2a; N=81; Not yet recruiting; Sponsor: Kenneth Krantz, MD, PhD

New P2a trial • Infectious Disease • Novel Coronavirus Disease

Selva Therapeutics Announces Successful Completion of Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19 (Businesswire) - P1, N=NA; "Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213...The company plans to rapidly advance SLV213 into a Phase 2 study in non-hospitalized COVID-19 patients....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."

P1 data • PK/PD data • Trial completion • Infectious Disease • Novel Coronavirus Disease

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

IND • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] BLOCKAGE OF CATHEPSIN L ACTIVITY BY SLV213, A NOVEL CYSTEINE PROTEASE INHIBITOR, PREVENTS SARS-COV-2 VIRAL ENTRY (ISIRV-AVG 2020) - No abstract available

Infectious Disease • Novel Coronavirus Disease • CTSL