Claritas Pharmaceuticals (OTCPK:KALTF) and CMAX Clinical Research which entered an agreement to start Phase 1 clinical study to evaluate the pharmacokinetics and safety profile of R-107, expanded the program to include the treatment of COVID-19 related sepsis, the leading cause of death in COVID-19 patients. R-107 is a liquid, nitric oxide-releasing compound that has demonstrated promising data in an animal study model for the treatment of pulmonary arterial hypertension (PAH).
Earlier this month, Claritas announced that it will enter into a separate License Agreement under which Salzman Group will grant exclusive, worldwide rights to develop R-107 for the treatment of PAH.
The study is expected to begin enrollment of 32 healthy middle-aged volunteers in 4 ascending dose cohorts in early Q3 this year, and will have a duration of two months.
Following the Phase 1a study, Claritas plans Phase 2a clinical pilot study in early 2022 in order to enable full characterization of the level of effectiveness of R-107 in patients with severe PAH. Following completion of the CMAX Phase 1a study, the Company plans to initiate a Phase 1b repeat dose study in Q4 this year. Data from this study are intended to support planned Phase 2a clinical studies in the treatment of COVID-19 infection, as well as COVID-19 related sepsis, each of which studies is expected to be initiated during 1H 2022.
The stock was up over 16% in late morning trading.
