The Australian Human Research Ethics Committee has approved Claritas Pharmaceuticals’ (TSXV:CLAS; OTC:CLAZF) submission for the Phase 1 clinical study of R-107 to be conducted at Scientia Clinical Research in Sydney. Enrollment in the study will begin immediately.
R-107 is a liquid, nitric oxide-releasing compound, with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.
R-107 is designed to overcome the limitations of nitric oxide inhalation therapy. Unlike gaseous nitric oxide, R-107 is a liquid that can be administered by mouth in a capsule, by nasal spray, by nebulizer, by injection, by suppository or topically in an ointment.
The Phase 1 study will be a double-blind, single-center, single ascending dose escalation study that will evaluate the tolerability, safety, and pharmacokinetics of R-107 intramuscular injection. The study will enroll a total of 40 subjects, with 8 subjects in each of 5 cohorts.
Following completion of the Phase 1 study, Claritas will initiate a Phase 2a clinical study of R-107 in the treatment of in pulmonary arterial hypertension (PAH).
“The data that we have with R-107 in the treatment of PAH is of particular importance and is indictive of the potential value of R-107,” Robert Farrell, president of Claritas, said in a statement.
Mr. Farrell said R-107 was evaluated in the same animal model of PAH in which the currently approved drugs for PAH were also tested. “R-107 was observed to be superior to all currently approved drugs in reducing pulmonary arterial blood pressure. R-107 also was seen to reverse the severity of the disease after a short course of therapy. R-107 is the first and only drug to demonstrate the ability to reverse established disease.”
Mr. Farrell said that if the company can demonstrate similar data with R-107 in a Phase 2 clinical study in humans, “we believe that R-107 will be viewed as a potentially valuable pharmaceutical asset that we might seek to out-license or sell.” Claritas has already begun outreach to pharmaceutical companies in the PAH space and is in discussions with two such companies, he added.
In addition to the Phase 2a clinical study in PAH, Claritas plans to initiate a Phase 2 study in persistent pulmonary hypertension of the newborn (PPHN). Inhalable nitric oxide is already approved for the treatment of PPHN.
