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. Author manuscript; available in PMC: 2025 Mar 1.
Published in final edited form as: Biomaterials. 2024 Jan 2;305:122464. doi: 10.1016/j.biomaterials.2023.122464

Table 4.

Assessment of protein-based drug delivery systems in humans.

Drug Description ID Phase Indication # pts Outcome Ref
Elastin-like polypeptides
PB1046 Recombinant fusion of vasoactive intestinal peptide (VIP) and ELP NCT03315507 1 Pulmonary arterial hypertension 3 Dosed SC q1w for > 8 weeks, well tolerated. Improved disease in 1 pt 164
NCT02808585 2 Heart failure w/reduced ejection fraction 29 Dosed SC q1w for 4 weeks up to 1.2 mg/kg, well tolerated. Significant reductions in diastolic BP vs placebo 221
PB0139 Recombinant fusion of native insulin and ELP NCT01835730 1 T2D 37 Dose dependent decrease in FBG (range of −2 to −34 mg/dL). Well tolerated 222
PB1023 Recombinant fusion of glucagon-like peptide 1 (GLP-1) and ELP NCT01236404 1/2a T2D 80 Dosed SC q1w for 4 weeks. Induced significant reductions in FBG in a dose-dependent manner 223
NCT01658501 2b T2D 593 Dosed SC q1w for 4 weeks up to 1.35 mg/kg. Significant reductions in FBG at lowest tested dose (0.3 mg/kg) 2241/ 2/2024 5:42:00 PM
Gelatin
Drug-loaded gelatin MPs Cisplatin-conjugated gelatin microspheres bFGF-loaded gelatin microspheres N/A 1 HCC 19 Transarterial chemoembolization using microspheres, ~48% nodule response rate 225
bFGF-loaded gelatin microspheres N/A 1 Critical limb ischemia 10 IM injection of 200 μg bFGF-incorporated gelatin MPs enabled significant improvement in tissue oxygenation 24 weeks post treatment 226
Albumin
Nab-paclitaxel Paclitaxel loaded onto human albumin NCT00046527 3 Metastatic breast cancer 460 IV injections in 3-week treatment cycle. Albumin-loaded paclitaxel induced higher response rates than paclitaxel alone (33% vs 19%) 227
NCT00844649 3 Pancreatic cancer 861 Gemcitabine + nab-paclitaxel improved survival rates vs gemcitabine alone 228
Silk
VX-103 Antigen-loaded silk fibroin microneedle array NCT06125717 1 H1N1 influenza 45 Seroprotection rate of 92% at highest tested dose. Well tolerated. 229
Ferritin
H2HA-Ferittin Ferritin nanoparticle presenting HA domain from H2N2 influenza virus NCT03186781 1 H2N2 influenza 50 Neutralizing antibody responses induced following IM administration 2301/2/2024 5:42:00 PM

bFGF, bovine fibroblast growth factor; FBG, fasting blood glucose; IM, intramuscular; IV, intravenous; q1w, once weekly; MP, microparticles; SC, subcutaneous.