Claritas Announces Agreement with CMAX Clinical Research for Phase 1 Clinical Study of R-107
SAN FRANCISCO and TORONTO, April 21, 2021 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today
announced that it has entered into an agreement with CMAX Clinical Research Pty Ltd (“CMAX”) to conduct a randomized, placebo-controlled, single-blind, single ascending dose Phase
1 clinical study to evaluate the pharmacokinetics and safety profile of the Company’s novel, liquid, nitric oxide-releasing drug, R-107.
R-107 is a Nitric Oxide-Releasing Compound
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.
Claritas initially licensed R-107 from Salzman Group for the treatment of COVID-19 and other viral infections. Claritas announced on April 14, 2021 that, subject to TSXV approval, it will enter into a separate License Agreement under which Salzman Group will also grant to Claritas exclusive, worldwide rights to develop R-107 for the treatment of PAH.
R-107 can be administered by injection, in contrast to nitric oxide gas therapy which requires a special type of delivery device and complex administration by trained respiratory therapists. When administered by intramuscular (“IM”) injection, R-107 steadily and slowly releases nitric oxide. This depot-like action of R-107 results in a sustained delivery of nitric oxide to tissues throughout the body, allowing for a smooth delivery of the active drug over 24 hours following a single dose of R-107.
In a gold-standard classic animal model of PAH, IM dosing of R-107 demonstrated pulmonary-selective vasodilation and a durable normalization of pulmonary blood pressure that persisted after the cessation of therapy. This latter effect, representing a stable reversal of established disease, is an unprecedented in vivo observation and suggests that R-107 may be able to stably reverse PAH in the clinical setting, a benefit that has eluded all of the existing group of approved PAH therapeutics.
Phase 1 Clinical Study to be Conducted by CMAX in Adelaide, Australia
CMAX, located in Adelaide, South Australia, is one of Australia’s largest and most experienced Phase 1 and Phase 2 clinical trial units. CMAX conducts successful world-leading research for Australian and international clients, specializing in a range of clinical trials and first-in-human studies.