Icosavax Shares Plummet Following Interim Results From Initial-Stage RSV Vaccine Study

Icosavax ICVX announced interim results from its Phase 1/1b clinical trial of IVX-121, respiratory syncytial virus (RSV) F antigen, in young and older adults.

The Phase 1/1b clinical trial is designed to evaluate the safety and immunogenicity of three dose levels of IVX-121.

The Phase 1 part of the trial enrolled 90 healthy young adults aged 18-45 years, while the Phase 1b part of the trial enrolled 130 healthy older adults aged 60-75 years.

Adam Simpson, Chief Executive Officer, commented : "I'm delighted to share these topline, interim data from our Phase 1/1b trial in RSV, in which IVX-121 demonstrated a robust immunologic response in both young and older adult groups. Importantly, we believe these Phase 1/1b data provide initial validation of our underlying VLP technology. They also reaffirm our strategy to combine multiple pathogen targets in one vaccine.”

The clinical data readout from the Phase 1/1b study will also support a Phase 1b extension study.

Additionally, Icosavax is planning towards the development of IVX-121 combined with a human metapneumovirus (hMPV) VLP, as its IVX-A12 bivalent vaccine candidate.

The company intends to submit an Investigational New Drug (IND) application for IVX-A12 to the U.S. Food and Drug Administration (FDA) followed by initiation of Phase 1 clinical trial in the second half of 2022.

Icosavax Shares are trading down 22 percent at $6.59 in the after hour session.