Decoy Therapeutics Inc. (DCOY), a pre-clinical stage biotechnology company, announced that it has entered into a strategic development agreement with a European based pharmaceutical service partner, hVIVO plc (HVO.L) to advance its lead Designable Multi-Antiviral or D-MAV candidate into Phase 1 first-in-human and Phase 2a proof-of-concept studies or PoC.
Decoy's lead programs are focused on respiratory viral infections.
As part of the deal, hVIVO will provide Decoy with regulatory strategy, translational modelling, scientific advice preparation, CMC consulting, non-clinical development support and regulatory documentation process for European and UK clinical trial submissions.
The engagement includes support for regulatory interactions with both the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
On the other hand, Decoy intends to use the resulting data generated to update on clinical development strategy, Phase 1 dose selection, translational pharmacology planning, challenge study design considerations, and Phase 2a development activities.
The combined effort by both companies is intended to support translational modelling, regulatory planning and early clinical execution, and future IND/CTA filings and Decoy's longer-term goal of pursuing U.S. registration of its D-MAV programs with the Food and Drug Administration or FDA.
DCOY is currently trading at $9.40, up 5.38%
HVO.L is currently trading down 2.11% to £8.13 on the London Stock Exchange.
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