By Brad Sorensen, CFA
NASDAQ:REVB
READ THE FULL REVB RESEARCH REPORT
Revelation Biosciences (NASDAQ:REVB) released test results for its Gemini product that we believe validate our positive view on the company and suggest major advancements in the treatment of inflammation, which causes problems for millions of Americans.
Gemini is an intravenously administered treatment that reduces the damage associated with inflammation, which could be used in treating numerous conditions. Gemini is currently in a Phase 1b trial for chronic kidney disease (CKD), which approximately 37 million people are afflicted with. The company just released data from its Phase 1 PRIME clinical study in stage 3 and 4 CKD patients. The primary endpoint to evaluate safety and tolerability of escalating doses was met.
But the major news was that Gemini reduced inflammatory activity and restored normal cellular response. This demonstrates Gemini’s ability to durably rebalance the inflammatory process at the cellular level. This has implications for dozens of afflictions, such as CKD and burns, and makes the process toward commercialization more likely in our view. The statement from the Principal Investigator made us take additional notice as it was more positive than what we have often seen. Dr. Pablo Pergola, Research Director at Clinical Advancement Center, PLLC, noted, “The activity observed with a single dose of Gemini in patients is shocking. This effect suggests a meaningful step forward in addressing the underlying immune dysregulation observed in patients with chronic kidney disease, and I am intrigued by the potential of Gemini to treat multiple types of acute and chronic inflammation.”
Specifically, test results showed that in patients with high background PBMC activity, which are immune cells and can help measure inflammation, Gemini significantly reduced inflammation relative to placebo patient PBMCs post dose and remained significantly below their baseline value through 7 days. Background inflammation was reduced to levels comparable to PBMCs isolated from healthy subjects. The importance of this cannot be overstated. Gemini is changing the cells and returning them to a normal state from the inflamed state, which treats the patient durably instead of just masking the symptoms. This ability has the potential to positively affect millions of patients suffering from CKD and other inflammatory diseases in a way that has been impossible to this point.
Company management noted the excitement and importance of these results and noted that it was looking forward to the scheduled End of Phase I meeting with the FDA later this year to discuss the advancement of Gemini and believes that these results may help to accelerate the approval process.
We are under no illusions that it’s easy to bring new therapies all the way to commercialization, but view these results as a significant step forward to that goal. As a result, we urge investors to use this groundbreaking news to consider investing in REVB.
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