RSI Biotherapeutics Reports Positive Results from Proof-of-Concept Trial for First Investigational Compound

Data supports theory that RSBT-001 can positively impact damaging inflammation without eliminating beneficial immune response

CUMBERLAND, Md. – July 11, 2022 – RS BioTherapeutics, whose mission is to harness its strong and thorough understanding of the endocannabinoid system (ECS) to research, develop and commercialize interventions to address chronic and acute pulmonary (lung) inflammation-based diseases, is pleased to announce positive results from its proof-of-concept study for its first investigational compound, RSBT-001.

RSBT-001 is a patent-pending, nebulized, semi-synthetic, cannabidiolic acid (CBDa) complex in development to address exacerbation and prevent progression of both acute and chronic pulmonary inflammation related to respiratory diseases including COPD, SARS-COV-2, Cystic Fibrosis, Asthma, Bronchitis, and Acute Respiratory Distress Syndrome.

RS BioTherapeutics conducted the study in conjunction with RSBT-001 development partner, Synthonics, Inc., and Marshall University using a mouse model of pulmonary inflammation.

The proof of concept model was created by instilling E. coli derived lipopolysaccharide (LPS) intranasally. Anti-inflammatory response was determined by measuring a series of cytokines known to be highly expressed in response to pulmonary inflammation. RSBT-001 was dosed at 1 mg/kg intranasally and its performance was measured against a positive control, dexamethasone, at 2.5 mg/kg and 10.0 mg/kg dosed intranasally; a negative control (LPS only); and vehicle only. Both RSBT-001 and dexamethasone were administered in a single dose 8 hours after insult. Cytokine measurements were made with mouse lung homogenate at 12 hours, 24 hours, and 48 hours after test material administration.

Justin Molignoni, CRNP, Chief Strategy Officer and Co-Chair of the RS BioTherapeutics Joint Development Committee said, “The data from the proof-of-concept trial clearly indicates that RSBT-001 reduces cytokine level, and that this cytokine reduction is appropriately transient. This supports the theory that RSBT-001 can reduce the harmful effects of an overstimulated immune system, which causes damaging inflammation, but does not completely suppress the immune response, which is important to retain in order to continue to fight off the insult or infection.”

Thomas Piccariello, Ph.D., Co-Chair of the RS BioTherapeutics Joint Development Committee and Co-Founder, President and Chief Science Officer of Synthonics, Inc. said, “Our conclusions are that RSBT-001 approached normalization of IL6, IFNγ, IL-12p70 and IL-1β relative to baseline at the 12 and 24 hours timepoints. Moreover, RSBT-001’s response was similar to dexamethasone’s 2.5 mg/kg responses. In this trial, RSBT-001 demonstrated exactly what we want to accomplish with any anti-inflammatory agent: down regulate cytokines to the appropriate therapeutic level but not eliminate cytokines altogether. Completely eliminating cytokine expression is what corticosteroids, like dexamethasone, can do, which allows secondary infections to occur.”

Adding to the discussion, Hongwei Yu, Ph.D., a professor in the Marshall University School of Medicine and one of the lead researchers on the study noted, “The results of the proof-of-concept study for RSBT-001 were exciting. We are looking forward to participating in additional studies to determine the precise dosing of RSBT-001 that is most effective at preventing lung inflammation as well as its safety and adverse event profile.”

RS BioTherapeutics has initiated a second study with Marshall to further evaluate the impact of RSBT-001 on pulmonary inflammation.

About RS BioTherapeutics
Founded by experts in pulmonary diseases and the endocannabinoid system, RS BioTherapeutics is a wholly owned subsidiary of Real Science Holdco LLC. The company’s mission is to harness its strong and thorough understanding of the Endocannabinoid System in the research, development, and commercialization of forward-thinking interventions to address chronic and acute pulmonary inflammation-based diseases. More information on RS Biotherapeutics can be found at

About Synthonics
Synthonics, Inc. is a privately-held specialty pharmaceutical company focused on the discovery and development of patentable drugs that incorporate its proprietary metal coordination chemistry. It binds metals to known pharmaceutical agents to create new products that are better absorbed and thus have greater therapeutic benefits than their predecessors. More information on Synthonics can be found at

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