Vaxart Inc. (NASDAQ:VXRT) is moving closer to having clinical data for its oral COVID-19 vaccine candidate after it announced that the FDA had cleared its IND application for Phase 1 trial evaluating the vaccine candidate. The company has also offered an update in the COVID-19 program.
Vaxart To enroll patients in the Phase 1 study this month
Normally the FDA will review INDs to ascertain no safety concerns in animal preclinical data before companies can commence human clinical trials. Vaxart’s Phase 1 study is expected to commence patients’ enrollment this month and test two doses of the oral vaccine in patients aged 18-5 years. However, the company has not indicated the number of patients they plan to enroll and how long they will administer the dose.
Since this is an early-stage study, the objective will be checking on the safety profile of the vaccine, but they will also look at an immune response like antibodies creations against SARS-CoV-2 and of participants can develop COVID-19. The company’s CEO Andrei Floroiu stated that the study’s goal is to deliver an elegant solution that confers to mass protection against the coronavirus. He stated that Vaxart’s oral vaccine provides an attractive administration mode compared to injectable, and there is a possibility of it offering enhanced protection because of activation of mucosal immunity.
Vaxart’s oral vaccine convenient, cheaper, and easier to store
Andrei added that most importantly, the tablet is room-temperature stable, making it cheaper and easier to store and distribute across the US and globally into remote areas. The Vaxart tablet vaccine doesn’t require the complex and costly refrigerated cold chain that injectable vaccine requires. Also, the CEO added that the IND clearance is a huge milestone, and the commencement of Phase 1 clinical trial takes the company a step closer to proving the superiority of its oral COVID-19 vaccine candidate.
The company is currently conducting two animal challenges studies, and it expects to offer efficacy and understanding of optimal dose regiment for the vaccine with results due in mid-October.