Pre-IND Meeting Briefing Document — GLPI-103
| Field | Value |
|---|---|
| Document ID | MTG-PREIND |
| Version | 1.0 |
| Status | Final (portfolio) |
| Meeting type | Type B (Pre-IND) — FDA, Division of Diabetes, Lipid Disorders, and Obesity [MOCK] |
| Compound | GLPI-103 (GLP-1 / Apelin [APJ] receptor dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard(s) | 21 CFR 312.82 · FDA Formal Meetings Guidance (PDUFA VII) · ICH M3(R2) |
| Confidentiality | Confidential |
[MOCK]Briefing document supporting a Pre-IND meeting to align on the nonclinical package, first-in-human design, and CMC adequacy to support the IND.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-30 | Regulatory Affairs | Initial Pre-IND briefing document |
1. Meeting Objectives
To obtain FDA agreement that (i) the nonclinical pharmacology/toxicology package supports first-in-human dosing, (ii) the proposed Phase 1 SAD/MAD design and starting dose are acceptable, and (iii) the CMC and clinical pharmacology plans are adequate for the IND.
2. Product Background and Rationale
GLPI-103 is a first-in-class synthetic peptide dual agonist of the GLP-1 and apelin (APJ) receptors for T2DM, combining established GLP-1 glycaemic/weight benefit with APJ-mediated insulin-sensitizing, vascular, and myocardial effects (M2.5; PM-007).
3. Summary of Supporting Data
- Nonclinical: primary/secondary pharmacology, safety pharmacology (hERG, CV/respiratory), GLP toxicology in rat and non-human primate, genotoxicity, and toxicokinetics; NOAELs support the proposed starting dose with adequate margins (M4-2.4/2.6).
- CMC: peptide drug substance (SPPS) and IV/oral drug products with a permeation enhancer; specifications, stability, and GMP status summarized (M3).
- Starting dose: MABEL/NOAEL-based with HED conversion and safety factor (M2.4).
4. Proposed Phase 1 Program
SAD (40 healthy volunteers, 5 cohorts) and MAD (40 T2DM/prediabetes, 4 cohorts), with sentinel dosing, stopping rules, and PK/PD (apelin, NT-proBNP, hsCRP) (PM-007 §6).
5. Questions for the Agency
- Does the Agency agree that the nonclinical package is adequate to support the proposed first-in-human single- and multiple-ascending-dose studies?
- Does the Agency agree with the proposed starting dose and dose-escalation scheme, including the MABEL/NOAEL rationale and safety factors?
- Does the Agency concur that the proposed safety monitoring (sentinel dosing, stopping rules, AESI definitions including thyroid C-cell and pancreatitis surveillance) is appropriate?
- Does the Agency agree that the CMC information proposed for the IND (drug substance/product controls and stability) is sufficient to support Phase 1?
- Are there specific requirements for the clinical pharmacology package (e.g., dedicated QT, hepatic/renal impairment) that should be planned now?
6. Proposed Agreements
Sponsor seeks written agreement on Questions 1-5 to enable IND submission within ~60 days of the meeting.