Stephanie Culler, Ph.D., CEO of San Diego-based Persephone Biosciences, is serving as chief investigator on a trial ultimately aiming to enroll up to 10,000 ethnically diverse participants nationwide for a study called “VOICES.”
Through the sample collection, the biotech is working to find the microbiome composition lending the best immune response to COVID-19 vaccines, and pending results of the study, could potentially effort a microbiome therapeutic. This would involve a weeks-worth of pills with dried bacteria to take along with vaccination to boost the immune system and enhance vaccine efficacy.
“The data that we’re getting out of this could be very, very impactful on opening the eyes of these larger pharma companies that the microbiome and data at least should be very much taken into account on how that’s going to impact vaccine response,” Culler told Fox News.
Culler notes the large-scale clinical trials conducted prior to FDA emergency authorization predominantly involved healthy, younger trial participants, whereas those battling cancer, diabetes, or those who are overweight may have damaged microbiomes and inflammation affecting their immune response. The therapy differs from a probiotic in that it involves novel bacteria from the gut microbiome necessitating FDA guidance and approval, the CEO explained.
The study involves two sample collections; one prior to vaccination to establish participants’ baseline microbiome, immune system and overall health, and the follow-up collection would occur after the first vaccine, depending on which vaccine was taken. Any patients who go on to develop COVID-19 would become eligible for an additional part of the study involving sequencing of variants.
Trial investigators are in talks with BARDA to gain government funding for the initiative and are looking to partner with drug makers like Pfizer and Moderna to scale up the study reach, according to Culler. Persephone intends to publish results in a journal and offer the findings to the major drug makers so the data could potentially be worked into next-generation or booster vaccines, which are currently in the works. Fox News’ requests for comment to Pfizer, Moderna, Johnson & Johnson and AstraZeneca were not returned.
Culler was confident the bacterial replacement therapy would clear regulatory hurdles with ease because the FDA has already established guidelines for so-called “live biotherapeutic products,” or LBPs, and said many other companies have ongoing late-stage trials with comparable products.
Depending on the results of the study, messaging could extend as far as advising against taking antibiotics prior to vaccination, the CEO confirmed. When questioned whether news of the trial would stir alarm among many of those at-risk individuals who have already completed a full course of COVID-19 vaccination, Culler said antibiotics for serious causes remain critical for saving lives but advised people with concerns to seek physician’s guidance.