ENHANZE® Typical Development Timeline
Project Initiation
Conduct compatibility and short-term in-use stability assessments to support Phase 1. Halozyme provides PK/PD modeling support to inform clinical trial design and dosing strategies.
Phase 1
Leverage ENHANZE® Drug Product (EDP) for mix-and-deliver with the co-administered drug product, i.e., no co-formulation is required for cGMP production of co-formulated drug product. Halozyme provides ENHANZE® pharmacy manuals and drug administration instructions for use by the clinical sites. In parallel, co-formulation development is initiated to prepare for later stage clinical trials.
Phase 2/3
For new programs without previous Phase 2 and 3 data, a traditional clinical development approach applies. For late-stage clinical or commercial programs, repeating the entire Phase 2 and 3 development programs with rHuPH20 may not be necessary; rather, an abbreviated Phase 3 trial with PK non-inferiority as the primary endpoint has been a proven path for partners.
Regulatory Submission
Halozyme has established rHuPH20 Module 3 CMC documents, pre-approved dossiers, iBLAs (US), and DMFs (Japan, China). Halozyme’s dedicated SMEs are on-call to answer RFIs and provide experience with global health authorities.
Post-Approval
Halozyme provides an annually-updated rHuPH20 Investigator’s Brochure and conducts routine immunogenicity screening for anti-rHuPH20 antibodies.