NASDAQ:REVB
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Revelation Biosciences (NASDAQ:REVB) announced that the FDA has accepted the company’s IND application for Gemini. This announcement allows the Company to initiate its US based Phase 1b clinical study to evaluate the potential of Gemini as a preconditioning treatment in patients with chronic kidney disease (CKD). This is extremely good news for the progression of this important treatment that has showed so much promise in earlier tests as we’ve discussed before.
According to the company, the multi-site, placebo-controlled Phase 1b clinical study will enroll up to 40 subjects in up to 5 cohorts. The primary endpoint is evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics, and the potential of Gemini to mobilize and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy.
As a reminder, earlier this year the company announced data from its Phase 1 trial of Gemini. This study involved 40 healthy individuals between the ages of 18 and 55 who were given placebo, low, mid and high doses. The primary purpose was to determine what the appropriate dosage was to use for further studies as well as evaluating the safety of Gemini. Those goals were both met, with the company noting that Gemini was generally well tolerated, with adverse events increasing as the dose increased. It’s important to note that Gemini administration did not result in any significant changes in clinical safety markers. The company also noted that the mid-level dose is now established as the maximum tolerated dose in healthy volunteers.
Another round of positive data from the upcoming Phase 1b study should then lead to, according to company management, a Phase 2 study of the treatment as a preconditioning treatment in patients with CKD to reduce the incidence, duration, and severity of acute kidney injury (AKI) in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery.
As another reminder about issues we’ve written about, Gemini is also being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program).
We are under no illusions that it’s easy to bring new therapies all the way to commercialization and Revelation will undoubtedly face challenges, but we believe that REVB is worth a look by investors due to the potential of the treatments being investigated, the science that has already been established behind those treatments, and the experienced management team the company has, headlined by the CEO who has overseen six INDs and two marketing approvals—experience we believe is needed to shepherd these treatments through the gauntlet of the FDA.
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