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Claritas (TSXV:CLAS) partners with CMAX Clinical Research for phase 1 R-107 clinical study

Health Care, Market News
TSXV:CLAS
21 April 2021 09:00 (EDT)

Claritas Pharmaceuticals (CLAS) has entered into an agreement with CMAX Clinical Research Pty Ltd. to conduct a Phase 1 clinical study of R-107.

R-107 has issued and pending 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 that it will enter into a separate license agreement under which Salzman Group will also grant 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 injection, R-107 releases nitric oxide. This depot-like action of R-107 results in sustained delivery of nitric oxide to tissues throughout the body, allowing for smooth delivery of the active drug over 24 hours following a single dose of R-107.

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.

CMAX will conduct a Good Clinical Practice Phase 1a study of IM injectable R-107. The study is expected to begin enrollment in early Q3 this year and will last for two months. The study will involve 32 healthy middle-aged volunteers in 4 ascending dose cohorts.

The study will be carried out under full GCP compliance, so that its results may be fully recognized and accepted by regulatory authorities.

Funding for the clinical study at CMAX will be provided from an R&D expense refund that the company expects to receive next month from the Australian Tax Office.

Claritas Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs.

Claritas Pharmaceuticals, Inc. (CLAS) opened trading at $0.05 per share.

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