Biopharmaceutical company SAB Biotherapeutics (SAB) said on Monday that it has dosed the first patient with SAB-185 in the Phase 3 ACTIV-2 COVID-19 trial led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group.
According to the company, SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. The lower dose of SAB-185 will be assessed in Phase 3.
In addition, the company revealed SAB-185 is the second agent to upgrade to Phase 3 and the first polyclonal antibody therapeutic candidate in ACTIV-2, which is evaluating multiple investigational agents to treat early symptomatic COVID-19 in non-hospitalized individuals.
SAB-185 advanced from Phase 2 to the Phase 3 portion of the ACTIV-2 trial based on meeting pre-defined graduation criteria. Both the lower and higher doses of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for advancement to Phase 3 and appeared safe.
Under the Phase 3 portion of the ACTIV-2 trial, the company is enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.
Poolbeg PHarma plc receives notice of allowance for POLB 001 patent
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Micron Biomedical names new scientific advisor to CEO
Quanterix partners with leading health networks for Alzheimer's diagnosis advancements
Precision BioSciences reports FDA pre-IND feedback for PBGENE-HBV
VBI to sell manufacturing capabilities and enter new license agreement with Brii Biosciences
Ondine Biomedical's Steriwave shows promise in nasal pathogen reduction
BioSenic expands patent coverage for ATO therapeutic platform
PacBio unveils Nanobind PanDNA kit for enhanced DNA extraction solutions
Sequentify receives funding from Israel Innovation Authority
INOVIO plans BLA submission for INO-3107 as RRP treatment
ImmunityBio secures USD320m investment from Oberland Capital
Poolbeg Pharma prioritises promising RSV drug candidates identified through AI-led analysis
GHIT fund invests JPY500m in antimalarial drug clinical trial