Scoop: COVID vaccine pill maker posts positive Phase 2 results
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San Francisco-based biotech Vaxart, an underdog in the COVID response that's developing a vaccine that would be delivered in a pill, is reporting promising Phase 2 clinical trial data today, the company told Axios exclusively.
Why it matters: The two-dose vaccine candidate was "safe and well-tolerated" and produced immune responses against the wild strain of the virus, as well as subsequent strains including Omicron, officials said.
- It also showed what's called a mucosal antibody response which can provide an added layer of protection and help reduce viral transmission, they said.
- "We believe that the positive findings for multiple immunologic responses may ultimately translate to enhanced protection against infection with, and/or transmission of, SARS-CoV-2," said Sean Tucker, Vaxart's founder and chief scientific officer.
Be smart: As the first part of a Phase 2 study, this is still a relatively small study. It was based on 66 people.
- But it's an important milestone as the first time an oral COVID vaccine has concluded a Phase 2 trial, they said.
- They say the pill could be ultimately "groundbreaking" for the global delivery of COVID vaccines and help get ahead of new COVID variants.
By the numbers: The trial measured for immunogenicity, neutralizing antibodies, and mucosal responses, in addition to safety.
- They found COVID-19-specific serum neutralizing antibodies increased between 1.2- and 2-fold, with higher increases for higher vaccine doses.
- Among 18-to-55-year-old subjects previously vaccinated with mRNA vaccines, they found COVID-19-specific antibody levels in the blood increased 1.6-fold.
- About half of the participants, as well as half of the subjects that previously received an mRNA vaccine, had at least a 1.5-fold increase in mucosal antibodies.
Yes, but: The response by immune cells known as T cells was not as strong as they previously observed with their other COVID-19 vaccine candidate.
What to watch: The company is working on new Omicron-based vaccine candidates to evaluate in preclinical models this year and to advance to clinical trials in the first half of 2023.
- The company is planning more studies in 2023, including larger trials in the U.S. and internationally.
