SAB-176 / SAb Biotherap - LARVOL DELTA

Study of SAB-176 in Healthy Adult Participants (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: SAb Biotherapeutics, Inc. | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: SAb Biotherapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

SAB-176-103: A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: SAb Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

SAB-176-103: A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: SAb Biotherapeutics, Inc.

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

SAB Biotherapeutics Presents Positive Phase 1 and 2a Data for SAB-176 Influenza Immunotherapy at ISIRV-AVG Conference (GlobeNewswire) - "SAB Biotherapeutics...announced the presentation of positive safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176 at the AVG conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Seattle, Wash...In a Phase 2a challenge clinical trial, healthy adults (n=60) were given a 25 mg/kg dose of SAB-176 or placebo after being inoculated with H1N1. Results showed that SAB-176 was safe, well-tolerated, and demonstrated a significant reduction in viral load compared to placebo, as well as symptom reduction.Moreover, a preclinical study in mice indicated that the combination of low doses of SAB-176 and oseltamivir (Tamiflu®) provided protection against a lethal dose of H1N1 comparable to a high-dose of oseltamivir alone, highlighting the potential additive benefits of low dose combination therapy."

P1 data • P2a data • Preclinical • Infectious Disease

SAB Biotherapeutics Announces U.S. FDA Grants Breakthrough Therapy Designation to SAB-176 Influenza Immunotherapy (GlobeNewswire) - "SAB Biotherapeutics...announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains."

Breakthrough therapy designation • Infectious Disease • Influenza

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: SAb Biotherapeutics, Inc.; Trial primary completion date: Sep 2021 ➔ Apr 2021

Clinical • Trial primary completion date • Infectious Disease • Respiratory Diseases

Study of SAB-176 in Healthy Adult Participants (clinicaltrials.gov) - P2a; N=62; Active, not recruiting; Sponsor: SAb Biotherapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: SAb Biotherapeutics, Inc.; Trial primary completion date: Jun 2021 ➔ Sep 2021

Clinical • Trial primary completion date • Infectious Disease • Respiratory Diseases

Study of SAB-176 in Healthy Adult Participants (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: SAb Biotherapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Respiratory Diseases

Study of SAB-176 in Healthy Adult Participants (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: SAb Biotherapeutics, Inc.

New P2a trial • Infectious Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1; N=27; Active, not recruiting; Sponsor: SAb Biotherapeutics, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: SAb Biotherapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: SAb Biotherapeutics, Inc.

Clinical • New P1 trial • Chronic Kidney Disease • Infectious Disease