DiaPep 277

Summary

DiaPep277 (also known as p277) is a synthetic peptide immunotherapy developed by Peptor/Andromeda Biotech for the treatment of newly diagnosed type 1 diabetes mellitus (T1DM). It was designed to halt immune-mediated destruction of pancreatic beta cells and preserve endogenous insulin secretion. Despite initially promising Phase II results showing preservation of C-peptide levels, a large Phase III trial (DIA-AID 1) failed to meet its primary endpoint, leading to discontinuation of development. Additionally, concerns were raised about potential data integrity issues in subsequent trials.

Mechanism of Action

DiaPep277 is a 24-amino acid peptide derived from human heat shock protein 60 (HSP60). It acts as a tolerogenic peptide that shifts the immune response from a pro-inflammatory Th1 phenotype to an anti-inflammatory Th2/regulatory T-cell phenotype, thereby reducing autoimmune destruction of pancreatic beta cells. It binds Toll-like receptor 2 (TLR2) on immune cells, modulating innate and adaptive immunity to preserve residual beta-cell function in type 1 diabetes.

Routes of Administration

Goals & Uses

• Reduction of exogenous insulin requirementsMetabolicLow
• Preservation of beta-cell function in type 1 diabetesAutoimmune / EndocrineModerate
• Immune tolerance inductionImmunologyLow

Contraindications

• Known hypersensitivity to DiaPep277 or any formulation componentAllergyHigh
• Immunosuppressive therapyPharmacologicalModerate
• Active systemic infectionInfectiousModerate

Adverse Effects

• Hypersensitivity reactionsImmunologicRare
• Flu-like symptomsSystemic/ImmunologicalUncommon
• Injection site reactionsLocalCommon

Drug Interactions

• Immunosuppressants (e.g., corticosteroids, azathioprine)Moderate
• Other immunomodulatory biologicsModerate

Population Constraints

• Long-standing type 1 diabetes with no residual beta-cell functionDisease SpecificAbsolute
• Pediatric patients (<18 years)AgeRelative
• Pregnancy and lactationReproductiveRelative

Regulatory Status

• European UnionUnapprovedNever received EMA approval. Andromeda Biotech (Israeli company) discontinued development after Phase III failure and data integrity concerns.
• United StatesUnapprovedNever approved by the FDA. Phase III trial failed; development discontinued.
• United KingdomUnapprovedNo approval sought or granted in the UK.

Never received regulatory approval in any jurisdiction. Phase III trial (DIA-AID 1) failed to meet primary endpoint. A second Phase III trial (DIA-AID 2) was halted amid data integrity concerns. Development by Andromeda Biotech was discontinued.

Evidence & Sources

No sources recorded yet.