SNS812 / Microbio - LARVOL DELTA

SNS812, a Broad-Spectrum Antiviral siRNA, Demonstrates Safety and Clinical Efficacy in Treating COVID-19 in Phase I and II Trial (ATS 2025) - P1, P2 | "Mainstream treatments, like protease inhibitors and nucleoside analogs, have shown limited efficacy, particularly in vaccinated individuals, and are associated with a high rate of drug-related side effects, as demonstrated in recent Paxlovid trials. SNS812 demonstrated an excellent safety profile in both Phase I and II trials, showing significant clinical efficacy in symptom resolution and viral clearance. Its effectiveness against immune-evasive variants in vaccinated participants suggests that SNS812 could be a promising broad-spectrum antiviral therapy for COVID-19."

Clinical • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pharmacokinetics and Safety Profile of SNS812, a First in Human Fully Modified siRNA Targeting Wide-Spectrum SARS-CoV-2, in Healthy Subjects. (PubMed, Clin Transl Sci) - P1 | "The results demonstrated that the first-in-human, fully modified with wide-spectrum anti-SARS-COV2 siRNA by inhalation following a single dose and multiple doses was safe and well tolerated in healthy participants. Trial Registration: NCT05677893."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Antiviral Efficacy of a Broad-Spectrum siRNA SNS812 Targeting SARS-CoV-2: Phase II Trial (CROI 2025) - P1, P2 | "Conclusions The Phase II study demonstrates that SNS812 is a safe and effective treatment for COVID-19, especially in the context of immune-evasive variants. Its ability to significantly reduce viral load within one day, accelerate viral clearance, and improve symptoms positions SNS812 as a promising pan-coronavirus therapeutic solution, capable of addressing ongoing viral mutations."

Clinical • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: Oneness Biotech Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Oneness Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Trial completion date: Apr 2024 ➔ Sep 2024 | Trial primary completion date: Jan 2024 ➔ Jun 2024

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

A Study to Evaluate the Efficacy, Safety, and Concentration of SNS812 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Oneness Biotech Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Efficacy, Safety, Tolerability and PK of SNS812 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Oneness Biotech Co., Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Oneness Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Oneness Biotech Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases