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GB-0669 for COVID-19

GB-0669 has been reported as potentially beneficial for COVID-19 in the following study. We have not reviewed GB-0669 in detail.
COVID-19 involves the interplay of 300+ viral and host proteins and factors providing many therapeutic targets. Scientists have proposed 10,000+ potential treatments. c19early.org analyzes 170+ treatments.
Borriello et al., First-in-Human Study of a First-in-Class AI-Designed Monoclonal Antibody (GB-0669) Against the Conserved SARS-CoV-2 Spike S2 Stem Helix, medRxiv, doi:10.1101/2025.10.07.25337449
Background Antibodies against the SARS-CoV-2 spike receptor-binding domain provided effective COVID-19 treatment until resistant variants emerged. GB-0669 is a half-life extended monoclonal antibody optimized using artificial intelligence, targeting the conserved spike S2 stem helix, a region with limited selective pressure from natural infection- or vaccine-induced antibody responses. Methods Pre-clinical safety studies were conducted in cynomolgus monkeys. In the first-in-human trial, healthy adults aged 18-55 received single intravenous doses of GB-0669 or placebo in five ascending cohorts (100, 300, 600, 1200, and 2400 mg). Participants were monitored for 43 weeks to evaluate safety, pharmacokinetics (PK), and pharmacodynamics (PD; serum live virus neutralization). In vitro studies assessed neutralization of GB-0669 combined with antiviral drugs (remdesivir, nirmatrelvir, and molnupiravir). Results Pre-clinical studies revealed no safety concerns. In the clinical trial (n=51; 36 GB-0669, 15 placebo), GB-0669 was well-tolerated without dose-limiting toxicities; all adverse reactions were mild (Grade 1 or 2). PK showed dose-proportionality up to 2400 mg, with a half-life of 54 days. Dose-dependent increases in serum live virus neutralization occurred at 600 and 1200 mg, with separation from placebo. The estimated neutralizing index that adjusts GB-0669 serum concentrations for its in vitro neutralizing potency supported therapeutic efficacy for two weeks post-administration. Finally, in vitro experiments showed improved neutralization profiles of GB-0669 in combination with antivirals. Conclusions The data support exploring GB-0669 at 1200 mg in a Phase 2 trial for treating COVID-19 in immunocompromised individuals. The combination of GB-0669 with antiviral drugs may offer additional therapeutic benefits.
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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