Table 3.
Recombinant proteins and peptides in clinical and preclinical testing against SARS-COV-2.
| Drug Name | Details | Global Status | Company | Delivery Route | Omicron Inhibitory Activity | Clinical trials ID |
|---|---|---|---|---|---|---|
| Ensovibep (MP-0420; SKO-136) | Tri-specific DARPin (designed ankyrin repeat proteins), binds spike protein trimer; for both prophylactic and therapeutic uses. | Phase III | Molecular Partners, Switzerland, Novartis, Switzerland | Injectable, I.V. | active against Omicron BA.1 and BA.2. | NCT04501978 (ACTIV-3): recommendation to stop enrollment due to lack of clinical benefit |
| APN01 (alunacedase alfa) | soluble recombinant ACE2 extracellular domain | Phase II | Apeiron Biologics, Austria | inhaled, I.V. | n.a. | NCT04335136: completed |
| Neumifil (mCBM40) | recombinant protein based on CBM40 domain derived from bacterial sialidases | Phase II (influenza) | Pneumagen, UK | Inhaled, transnasal spray | broad-spectrum antiviral (influenza, RSV, COVID-19) | NCT05507567 (Human Influenza virus Challenge Model): recruiting |
| HLX71 | Recombinant ACE2-Fc fusion protein | Phase I | Hengenix Biotech Inc | Injectable, I.V. | n.a. | NCT04583228: recruitment completed |
| SI–F019 | SARS-CoV-2 neutralizing protein, mimics ACE2 and act as a neutralizing decoy | Phase I | Biokin Pharmaceutical, China | Injectable, I.V. | n.a. | NCT04851444: recruiting |
| ACE2 mutant | ACE2 mutant | Phase I/Ib | SignalChem Lifesciences, Canada; Innophore, Austria | Injectable | n.a. | n.a. |
| CG-SpikeDown | peptide-based product binding to RBD | Preclinical | Caregen | Inhaled | n.a. | NCT05234320: not yet recruiting |
| 2MA-1 | modified soluble human ACE2 | Preclinical | Masker MedTech, Switzerland | Inhaled | active against Omicron | n.a. |
| TB202-3 (TB202-63) | COVID-19 VHH nanobodies, ACE2 inhibitor | Preclinical | Twist Bioscience | Injectable | n.a. | n.a. |
I.V., intravenous; n.a., information not available.