VNRX-9945 / VenatoRx - LARVOL DELTA

Discovery of VNRX-9945, a Potent, Broadly Active Capsid Assembly Modulator as a Clinical Candidate for the Treatment of Chronic Hepatitis B Virus Infection. (PubMed, ACS Med Chem Lett) - "Additionally, 12 demonstrated robust efficacy in the adeno-associated virus mouse model of HBV (AAV-HBV) infection. This compound has advanced into Phase 1 clinical trials to evaluate its safety and pharmacokinetics in healthy volunteers, to enable treatment of chronic HBV infections."

Journal • Hepatitis B • Infectious Disease • Inflammation

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=32 | Terminated | Sponsor: Venatorx Pharmaceuticals, Inc. | N=80 ➔ 32 | Trial completion date: Feb 2022 ➔ Oct 2021 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2022 ➔ Oct 2021; Part 2 terminated, unrelated to safety.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Venatorx Pharmaceuticals (BIO 2022) - "Venatorx’s two lead antibacterial clinical-stage programs are intravenous (cefepime-taniborbactam) and oral (ceftibuten/VNRX-7145) broad-spectrum beta-lactam / beta-lactamase inhibitor combinations that are in Phase 3 and Phase 1, respectively. In addition, the first Venatorx antiviral compound (VNRX-9945), a Hepatitis B virus inhibitor, is in Phase 1 clinical development. The Company also has discovery-stage programs targeting a novel class of non-beta-lactam antibiotics called Penicillin Binding Protein (PBP) inhibitors that have the potential to circumvent 70+ years of resistance and usher in a new wave of antibacterial therapeutics."

Hepatitis B • Hepatology • Infectious Disease • Inflammation

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=80; Active, not recruiting; Sponsor: Venatorx Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Venatorx Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Venatorx Pharmaceuticals Announces First Patient Dosed in Phase 1 Study of VNRX-9945 for the Treatment of Chronic Hepatitis B Virus Infection (Businesswire) - "Venatorx Pharmaceuticals today announced that the first patient was dosed in a Phase 1 clinical trial evaluating VNRX-9945, a highly potent, broadly active viral replication inhibitor for the treatment of chronic hepatitis B virus (HBV) infection."

Trial status • Hepatitis B • Infectious Disease

[VIRTUAL] Discovery and preclinical profile of VNRX-9945, a potent, broadly active core protein inhibitor for the treatment of hepatitis B virus (HBV) infection (EASL-ILC 2021) - "VNRX-9945 is one of the most potent core inhibitors reported to date with demonstrated activity against both capsid assembly and de novo cccDNA formation in naïve primary hepato- cytes. The antiviral, pharmacokinetic and safety profile supports the inclusion of VNRX-9945 in future combination therapies that are optimized to achieve a functional cure for chronic HBV. VNRX-9945 is being advanced rapidly into clinical development as a potential best- in-class core protein inhibitor."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • PCR

Venatorx Pharmaceuticals to Present Preclinical Profile of its Hepatitis B Virus Clinical Candidate at the International Liver Congress 2021 (Businesswire) - "Venatorx Pharmaceuticals today announced that it will present at the International Liver CongressTM (ILC), the European Association for the Study of the Liver (EASL) annual meeting, which is scheduled to take place virtually June 23-26, 2021...VNRX-9945 demonstrated broad antiviral activity against multiple HBV genotypes in vitro and suppressed HBV DNA to below the lower limit of quantitation in an animal model of HBV infection."

Preclinical • Hepatitis B • Infectious Disease

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: VenatoRx Pharmaceuticals, Inc.

New P1 trial

Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate (Businesswire) - "VNRX-9945 Selected as 3rd Generation Hepatitis B Virus Orally Bioavailable CpAM; Clinical Trial Application and Phase 1 Planned for Second Quarter 2021...Venatorx is pursuing mutually beneficial partnership and/or collaboration opportunities for VNRX-9945."

New P1 trial • Hepatitis B • Infectious Disease