By Brad Sorensen, CFA
NASDAQ:REVB
READ THE FULL REVB RESEARCH REPORT
Revelation Biosciences (NASDAQ:REVB) is a life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease. Revelation has multiple product candidates in development that we believe have promising potential and are based on the biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system. The impact of PHAD on the immune system has been studied over multiple years and has been shown to have a positive effect on the human immune system. The company’s current therapeutic candidates are all based on the active ingredient PHAD, which is a synthetic version of MPLA, that is known to stimulate TLR-4. PHAD stimulation of TLR-4 leads to the production of multiple types of cytokines and chemokines which modulate the activity of the innate and adaptive immune response. Modulated activities may include stimulation and recruitment of infection fighting immune cells, down-regulation of inflammation, and/or upregulation of inflammation depending on the degree and nature of the stimulation which enables the multiple potential product candidates in development.
The current therapies being developed under the so-called Gemini project are:
The company just announced that it is targeting a new indication for Gemini for the prevention of infection in severe burn patients requiring hospitalization. According to data provided by the company, every year, approximately half a million Americans sustain burn injuries requiring medical intervention. While most burn injuries do not require admission to a hospital, about 40,000 patients are admitted, with approximately 30,000 of them needing specialized treatment at a certified burn center.
The total annual number of burn-related deaths is approximately 3,400, with invasive infection being the primary reason for death after the first 24 hours. The overall mortality rate for severe burn patients is about 3.3%, but this increases to 20.6% in burn patients with cutaneous burn and inhalation injury, versus 10.5% for inhalation injury alone. Invasive infection, including sepsis, is the primary cause of death after burn injury, accounting for an estimated 51% of deaths. Currently, there are no treatments approved for preventing systemic infection in burn patients and we believe testing results outlined below illustrate why Gemini could provide much-needed hope for these patients.
Company management recently announced that studies have shown that Gemini priming reduces the inflammatory response in human peripheral blood mononuclear cells (PBMCs) that were exposed to clinically relevant molecules on inflammation. According to company management, in this study, human PBMCs were primed with either Gemini or placebo followed by challenge with clinically relevant promoter molecules of inflammation including high mobility box protein-1 (HMGB-1) and lipopolysaccharide (LPS) in vitro. HMGB-1 is an endogenous damage associated molecular pattern (DAMP) that is generated during tissue injury (e.g. during surgery) which drives the inflammatory response. LPS is an exogenous pathogen associated molecular pattern (PAMP) that is generated from a bacterial infection and drives the inflammatory response associated with infection (e.g. fever).
After exposure of Gemini-primed PMBCs to either HMGB-1 or LPS, levels of multiple proinflammatory and anti-inflammatory cytokines including IL-1 beta, TNF-alpha, IL-6, IL-1 Receptor Antagonist, and IL-10 were measured. Priming with Gemini significantly decreased proinflammatory cytokines and significantly increased anti-inflammatory cytokines, relative to placebo. According to management, this fundamental change in responsiveness at the cellular level demonstrates how Gemini will protect against inflammation-mediated damage.
These results raise our optimism over the potential outcome from the ongoing, US-based Phase 1b clinical study to evaluate the potential of Gemini as a preconditioning treatment in patients with chronic kidney disease (CKD) as well as the approval of Gemini as a treatment for other conditions, such as the one described above.
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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