Pre-NDA Meeting Briefing Document — GLPI-103
| Field | Value |
|---|---|
| Document ID | MTG-PRENDA |
| Version | 1.0 |
| Status | Final (portfolio) |
| Meeting type | Type B (Pre-NDA) — FDA [MOCK] |
| Compound | GLPI-103 (GLP-1 / Apelin [APJ] receptor dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard(s) | 21 CFR 312.47 · FDA Formal Meetings Guidance (PDUFA VII) · ICH M4 (CTD) · M8 (eCTD) |
| Confidentiality | Confidential |
[MOCK]Briefing document supporting a Pre-NDA meeting to align on the content, format, and organization of the planned NDA, and to resolve outstanding review-readiness questions.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-30 | Regulatory Affairs | Initial Pre-NDA briefing document |
1. Meeting Objectives
To confirm that the planned NDA content and format are acceptable to support filing and review, including the adequacy of the efficacy/safety datasets, the integrated summaries, the CMC package, and the proposed labeling and risk-management approach.
2. Summary of Pivotal Results (GLPI103-301)
Both GLPI-103 formulations were superior to oral semaglutide on HbA1c CFB at Week 52 (IV −0.68%, Oral −0.34%; both p<0.001), with greater weight reduction (−14.5 / −10.3 vs −7.6 kg) and higher responder rates. Safety was class-consistent and gastrointestinal-predominant, with a tolerability trade-off (nausea higher in the IV arm, 32.3% vs 21.4%, p=0.003) managed by titration; 10 SAEs and 2 deaths (none treatment-related); no hepatotoxicity (eDISH) (CSR-301; M2.7.3/2.7.4).
3. Planned NDA Content and Format
eCTD Modules 1-5: full CTD Module 2 summaries (2.3-2.7), Module 3 (CMC, peptide drug substance + IV/oral products), Module 4 (nonclinical), Module 5 (CSR-301 + integrated summaries ISE-301/ISS-301 + early-phase CSRs); SDTM/ADaM datasets with Define-XML 2.1, ADRG/SDRG, and ARM (M5; DEF-301).
4. Datasets and Standards
CDISC-conformant SDTM and ADaM, validated (Pinnacle 21-equivalent conformance: 0 errors); reproducible analysis pipeline with reconciliation of all reported figures to source outputs (DEF-301; verification gates).
5. Questions for the Agency
- Does the Agency agree that the efficacy and safety data from the single pivotal study, supported by the integrated summaries, are adequate to support the proposed indication?
- Does the Agency agree with the content and format of the proposed eCTD submission, including the Module 2 summaries and the dataset/Define-XML/ADRG package?
- Does the Agency concur with the proposed labeling approach, including the boxed warning for thyroid C-cell tumors and the presentation of the IV vs oral tolerability trade-off?
- Does the Agency agree that the proposed REMS/risk-management approach (routine risk minimization + Medication Guide) is appropriate, without additional REMS elements?
- Does the Agency agree that the CMC package (including the SNAC permeation-enhancer justification and stability data) supports filing?
- Are there any datasets, analyses, or bridging information the Agency would require to be included to ensure a fileable, reviewable application?
6. Proposed Agreements
Sponsor seeks confirmation on Questions 1-6 to finalize the NDA for submission within ~90 days of the meeting.