$DCOYJun 1, 2026, 11:00 AMAI processed
Decoy (DCOY) partners with hVIVO to advance lead D‐MAV toward Phase 1/2a and human challenge studies
AI Summary
Decoy Therapeutics (DCOY) has engaged hVIVO to support translational modeling, regulatory strategy, CMC/nonclinical consulting and preparation for Phase 1 first‐in‐human and Phase 2a proof‐of‐concept studies for its lead D‐MAV respiratory antiviral, with planned regulatory interactions in the EU/UK and intent to pursue US registration. hVIVO's human challenge trial expertise and facilities are expected to inform dose selection and study design and create a repeatable clinical template for Decoy's D‐MAV portfolio, but the program is still preclinical and no IND/CTA has been filed.
Positives
- hVIVO engagement covers translational modeling, regulatory strategy, CMC, nonclinical support and Phase 1/Phase 2a study preparation
- Access to hVIVO's human challenge trial capability and facilities could accelerate rapid proof‑of‑concept readouts
- Collaboration aims to produce a repeatable clinical template for Decoy's AI‑designed IMP³ACT D‑MAV portfolio
Negatives
- Lead D‑MAV candidate remains preclinical and no IND/CTA has been filed yet
- Advancement and timelines are contingent on regulatory feedback and successful IND/CTA approvals
- The agreement is preparatory/consulting support and does not guarantee trial initiation, positive human data, or approvals