Icosavax has received fast track designation from the US Food and Drug Administration (FDA) for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, IVX-A12, in older adults aged 60 years and above.
Said to be the company’s first combination vaccine candidate, IVX-A12 targets RSV as well as hMPV, which are two of the top five causes of pneumonia in adult people.
Icosavax announced the commencement of a Phase I trial in October last year for evaluating IVX-A12 in up to 120 healthy older adults aged 60 to 75 years.
The randomised, observer-blinded, placebo-controlled, multi-center trial evaluated IVX-A12 with and without CSL Seqirus’ adjuvant MF59 in these people.
Topline interim results from this trial are expected in the middle of this year and subjects thereafter will be followed through 12 months after vaccination.
At present, Icosavax plans to start a Phase II trial for IVX-A12 in the second half of this year.
Icosavax chief medical officer Niranjan Kanesa-thasan said: “We are delighted to have received the Fast Track designation for IVX-A12, which we believe highlights the unmet medical need that could be addressed by developing a bivalent vaccine combination of RSV and hMPV. IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults.
“RSV is estimated to cause approximately 177,000 hospitalisations and 14,000 deaths each year in this population in the US alone and data support similar morbidity and mortality for hMPV.
“We will utilise the benefits of this important regulatory milestone to work to optimise the IVX-A12 development plan. In addition, we look forward to the upcoming topline results of our Phase I study, and thereafter to the planned initiation of our Phase II trial.”