{"id":692082,"date":"2022-10-04T16:18:59","date_gmt":"2022-10-04T20:18:59","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/icosavax-initiates-phase-1-trial-of-ivx-a12-against-rsv-and-hmpv-in-older-adults\/"},"modified":"2022-10-04T16:18:59","modified_gmt":"2022-10-04T20:18:59","slug":"icosavax-initiates-phase-1-trial-of-ivx-a12-against-rsv-and-hmpv-in-older-adults","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/icosavax-initiates-phase-1-trial-of-ivx-a12-against-rsv-and-hmpv-in-older-adults\/","title":{"rendered":"Icosavax Initiates Phase 1 Trial of IVX-A12 Against RSV and hMPV in Older Adults"},"content":{"rendered":"
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\n – IVX-A12 is the first combination bivalent vaccine candidate against both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) to reach clinical stage –<\/em>
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\n Phase 1 topline interim results expected in mid-2023 –<\/em>\n <\/p>\n

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\n Phase 2 initiation planned to follow in 2H 2023 –<\/em>\n <\/p>\n

SEATTLE, Oct. 04, 2022 (GLOBE NEWSWIRE) — Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases and a vision of creating pan-respiratory vaccines for older adults, today announced the initiation of a Phase 1 clinical trial of IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in older adults.<\/p>\n

IVX-A12 is comprised of IVX-121, Icosavax\u2019s RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax\u2019s hMPV prefusion F protein VLP vaccine candidate. The company previously announced positive topline interim Phase 1\/1b results for IVX-121 in June 2022.<\/p>\n

With this trial initiation, IVX-A12 becomes the first combination bivalent vaccine candidate against both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) to enter the clinic, and the first candidate from Icosavax\u2019s novel VLP platform to receive IND authorization in the U.S.<\/p>\n

\u201cThe initiation of a Phase 1 trial for IVX-A12 is an important step towards our vision for creating pan-respiratory vaccines, and I am pleased with the execution by our team. Not only is IVX-A12 Icosavax\u2019s first combination bivalent VLP vaccine candidate, it is also the most advanced vaccine candidate against both RSV and hMPV in older adults, and the only clinical stage VLP in this space,\u201d said Adam Simpson, Chief Executive Officer of Icosavax. \u201cThe inclusion of a proprietary prefusion hMPV-F component in a combination RSV\/hMPV vaccine candidate is differentiating from the current RSV candidates in Phase 3 development, and is intended to address two leading causes of pneumonia in one shot.\u201d<\/p>\n

Simpson continued, \u201cIn older adults, RSV is estimated to cause approximately 177,000 hospitalizations and 14,000 deaths each year in the U.S. alonei<\/sup>, and data support similar morbidity and mortality for hMPV. As such, we look forward to sharing topline results from this first trial of a combined RSV and hMPV vaccine candidate in mid-2023, and thereafter plan to initiate a Phase 2 trial of IVX-A12 in 2H 2023.\u201d<\/p>\n

\n IVX-A12 Phase 1 Trial Design<\/strong>\n <\/p>\n

The Phase 1 clinical trial of IVX-A12 is a randomized, observer-blinded, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of multiple dosage levels of IVX-A12, with and without CSL Seqirus\u2019 proprietary adjuvant MF59\u00ae<\/sup>.<\/p>\n

The company anticipates enrolling up to 120 healthy older adults aged 60 to 75 years. Subjects will be administered a single shot of IVX-A12, at one of three combination dosage levels below, or placebo:<\/p>\n