US-based startup RS BioTherapeutics has announced that a proof of concept study demonstrated that its RSBT-001 semi-synthetic cannabidiolic acid (CBDa) reduced but did not eliminate cytokines when dosed intranasally at 1 mg/kg in a mouse model of pulmonary inflammation. The study was conducted by researchers at Marshall University.
RS BioTherapeutics licensed the nebulized CBDa formulation from Synthonics in May 2022 and is developing RSBT-001 for the treatment of lung inflammation in diseases such as asthma, COPD, CF, and COVID-19. According to the company web site, RS BioTherapeutics believes “that RSBT001 provides therapeutic benefit through modulation of both the Interleukin response to inflammation and alveolar macrophages responsible for fibrotic changes within the lungs.”
RS BioTherapeutics Chief Strategy Officer Justin Molignoni commented, “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.”
Synthonics President and Chief Science Officer Thomas Piccariello explained, “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.”
Marshall University School of Medicine professor Hongwei Yu added, “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.”
Read the RS BioTherapeutics press release.