Claritas Pharmaceuticals and CMAX Clinical Research have signed an agreement to conduct a Phase 1 clinical study of R-107.
The clinical study is to evaluate the pharmacokinetics and safety of novel, liquid, nitric oxide-releasing drug, R-107.
R-107 is a liquid, nitric oxide-releasing compound with issued and pending composition of matter and method of use patents in around 40 countries, including the US, Australia, Brazil, etc.
Initially, Claritas licensed R-107 from Salzman Group to use it for the treatment of Covid-19 as well as other viral infections.
Earlier this month, the company has announced that it will sign a separate license agreement under which Claritas will be granted with exclusive and worldwide rights to develop R-107 for the treatment of pulmonary arterial hypertension (PAH).
Claritas stated that CMAX will conduct the Phase 1a study of IM injectable R-107 under full Good Clinical Practice (GCP) compliance.
This will allow the results to be fully recognized and accepted by regulatory authorities at the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency and the Therapeutic Goods Administration in Australia (TGA).
The study is expected to begin enrolment of nearly 32 healthy middle-aged volunteers in four ascending dose cohorts in early Q3 this year and will take two months.
Upon completion of the phase 1a study, Claritas is planning for a Phase 1b repeat dose study in Q4 this year.
The data from phase 1b study will support the planned Phase 2a clinical study, which is expected to begin in early 2022, in the treatment of Covid-19 infection and Covid-19 related sepsis.