Eflepedocokin alfa

Summary

Eflepedocokin alfa (UTTR1147A) is an investigational IL-22 Fc fusion protein developed by Genentech/Roche. It is being evaluated for conditions involving intestinal epithelial injury and dysfunction, including graft-versus-host disease (GvHD), alcoholic hepatitis, and other mucosal inflammatory conditions. It promotes epithelial regeneration and anti-microbial peptide production.

Mechanism of Action

Eflepedocokin alfa is a recombinant fusion protein consisting of IL-22 fused to an IgG2 Fc region, acting as an IL-22 receptor agonist. It binds to the IL-22 receptor complex (IL-22R1/IL-10R2) on epithelial cells, activating JAK1/TYK2 and downstream STAT3 signaling, thereby promoting intestinal epithelial repair, barrier function, and mucosal homeostasis.

Routes of Administration

Goals & Uses

• Alcoholic hepatitisHepatologyLow
• Mucositis (chemotherapy-induced)Oncology Supportive CareLow
• Graft-versus-host disease (GvHD) treatmentImmunology / TransplantModerate
• Intestinal epithelial repairGastroenterologyModerate
• Inflammatory bowel diseaseGastroenterologyLow

Contraindications

• Known hypersensitivity to eflepedocokin alfa or Fc fusion proteinsAllergy/ImmunologyHigh
• Active malignancy with STAT3-driven tumor proliferationOncologyModerate
• Severe uncontrolled infectionInfectionModerate

Adverse Effects

• Psoriasiform skin lesionsDermatologicRare
• Injection site reactionsLocalCommon
• NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
• FatigueGeneralCommonLow energy or tiredness
• Elevated liver enzymes (transaminases)HepaticUncommon
• Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

• Immunosuppressants (e.g., tacrolimus, cyclosporine)Moderate
• CorticosteroidsLow

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative
• Severe hepatic impairmentOrgan ImpairmentRelative
• Patients with active colorectal or pancreatic cancerOncologyRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval; clinical trials conducted in EU sites.
• United StatesInvestigationalUnder clinical investigation; no FDA approval. Orphan Drug Designation explored for GvHD.
• United KingdomInvestigationalNo MHRA approval; no separate UK regulatory designation confirmed.

Not approved by FDA, EMA, or other major regulatory agencies. Investigated in multiple Phase I/II clinical trials. Orphan Drug Designation has been explored for GvHD indications.

Evidence & Sources

No sources recorded yet.