__top__ — Vgd-097

(Prepared 14 April 2026) 1. Executive Summary VGD‑097 is a next‑generation small‑molecule inhibitor currently being advanced by Vanguard Therapeutics Ltd. (formerly known as Vanguard Bio‑Discovery). The compound belongs to a proprietary chemotype (the “VGD series”) that targets the RNA‑dependent RNA polymerase (RdRp) complex of several emerging RNA viruses, with a particular focus on the flavivirus and filovirus families. Early pre‑clinical data indicate nanomolar potency, a high barrier to resistance, and a favorable pharmacokinetic (PK) profile that supports once‑daily oral dosing.

Regulatory pathway: (US FDA), Orphan Drug (EVD, Lassa), Conditional Marketing Authorization (EMA) via the PRIME scheme; WHO PQ (Pre‑Qualification) anticipated post‑Phase 3. 5. Competitive Landscape | Agent | Class | Target | Development Stage | Key Advantages | |-------|-------|--------|-------------------|----------------| | Remdesivir | Nucleoside analogue | RdRp (active site) | Approved (COVID‑19) | Proven clinical data | | Favipiravir | Nucleobase analogue | RdRp | Phase 2 (EVD) | Oral, cheap | | Molnupiravir | Nucleoside analogue | RdRp (error catastrophe) | Approved (COVID‑19) | Oral, broad‑spectrum | | GS‑621763 | Pro‑drug of GS‑443902 | RdRp | Phase 2 (influenza) | High potency | | VGD‑097 | Non‑nucleoside allosteric inhibitor | RdRp (allosteric pocket) | Phase 2a (EVD) | High barrier to resistance, pan‑RNA‑virus activity, oral once‑daily dosing, minimal CYP interaction | vgd-097

Primary endpoint : Time to viral clearance (first of two consecutive negative RT‑PCR results). (Prepared 14 April 2026) 1

Pharmacodynamic (PD) read‑out : ex‑vivo inhibition of RdRp activity in peripheral blood mononuclear cells (PBMCs) demonstrated > 90 % target engagement at 30 mg. Design : Randomized, double‑blind, placebo‑controlled; 2:1 randomization (VGD‑097 30 mg PO qd vs. placebo) for 7 days; N = 48 (32 active, 16 placebo). The compound belongs to a proprietary chemotype (the

Inclusion : Confirmed EBOV infection (RT‑PCR Ct ≤ 30), ≤ 72 h from symptom onset, age 18‑65, no severe hepatic/renal failure.