Icosavax Inc (NASDAQ: ICVX) announced that it had received positive topline results for IVX-411 in Phase I/II study. The drug is a potential vaccine for COVID as it displays a receptor-binding domain for SARS-Cov-2.
According to Icosavax’s Chief Medical Officer, Niranjan Kanesa-thasan, despite the patients tolerating the drug suitably, the results were not as good as the company had predicted from its knowledge of VLPs and its preclinical data.
The company is investigating the reasons for the results
Icosavax’s CEO, Adama Simpson, adds that the company is dedicated to its VLP platform for respiratory vaccines. For this reason, the company is now investigating potential causes for the disappointing results.
The reasons could include drug admin, shipment, and manufacture. Since COVID-19 is endemic, it is more important than ever for the Icosavax to find a suitable vaccine. Moreover, the company will share interim data on IVX-121 in the second quarter of 2022. This compound is a potential vaccine for RSV. Its other compound, IVX- A12, works for human metapneumovirus and RSV.
How researchers conducted the study
The current Phase I/II clinical study is a placebo-controlled observer-blinded and randomized trial. Researchers are using it to test for IVX-411’s immunogenicity and safety on patients aged between 18 and 69 who haven’t contracted COVID-19 and those who have recently received a vaccine.
The trial participants got two doses of the vaccine, with the second coming after 28 days. They were split into groups and either given the compound or a placebo. Those who were COVID naive IVX-411 got doses of 125ug, 25ug, or 5ug with or without adjuvant therapy.
Volunteers who had initially received IVX-411 doses at 125ug, 25ug, and 5ug with or without adjuvant therapy. They received shots after they had completed their initial vaccination. Moreover, the researchers evaluated if sera from the new vaccine neutralized their previous omicron immunizations
The results showed that the drug was well-tolerated and safe. Moreover, the systemic and local side effects that researchers observed were mild, highlighting that there wasn’t a need to discontinue the drug. Some of the side effects they noted were fatigue, headache, and tenderness in the injection site.
