other material
confidence high
sentiment neutral
materiality 0.60
Ainos submits clinical hold complete response to FDA for VELDONA Phase 2 COVID-19 trial
Ainos, Inc.
- Submitted clinical hold complete response to FDA for Phase 2 trial of low-dose oral IFN-alpha VELDONA for mild COVID-19.
- Phase 2 multicenter randomized study expected in Taiwan in Q3 2024 if approved.
- Updated CMC and stability data show VELDONA can exceed minimum shelf life for biologicals.
- Plans additional IND applications in H2 2024 for oral warts (orphan drug) and Sjögren's syndrome.
- Low-dose oral VELDONA safety demonstrated in ~6,000 subjects across 68 clinical trials.