NR this AM SAN FRANCISCO, CA and TORONTO, ON , Feb. 22, 2022 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that it has received comments from the Australian Human Research Ethics Committee (the “HREC”) regarding the Company’s Phase 1 clinical study of R-107, and is providing an update regarding the company’s previously announced financing with Alumina Partners (Ontario) Ltd. (“Alumina”).
Claritas will respond to the HREC’s comments later this week and expects to receive approval for the Phase 1 study shortly thereafter. HREC approval is the final regulatory step prior to initiation of the study.
“The comments we received from the HREC will not require that we make any changes to the Phase 1 study design,” stated Robert Farrell, Claritas’ President and CEO. “In general, the HREC requested clarification regarding the mechanism of action of R-107, and its active payload, R-100. When administered by injection, R-107 is slowly hydrolyzed, releasing its active moiety, R-100, which in turn steadily and slowly releases nitric oxide. This depot-like action of R-107 results in a sustained delivery of nitric oxide, allowing for a smooth delivery of the active drug over several hours following a single dose of R-107. Put simply, following injection, R-107 is metabolized, and releases R-100, which in turn releases nitric oxide. R-100 is the payload of R-107. The HREC requested clarification regarding the mechanisms of action for both R-107 and R-100.”
Phase 1 Study Overview
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. The study is being conducted at Scientia Clinical Research in Sydney, Australia.
Multiple Phase 2 Studies to be Conducted in 2H 2022
Following completion of the Phase 1 study, Claritas will initiate several Phase 2 clinical studies across multiple clinical indications, including pulmonary arterial hypertension (“PAH”); persistent pulmonary hypertension of the newborn (“PPHN”); and COVID-related sepsis and COVID-related ARDS.
As the Company previously announced, R-107 has been evaluated in validated animal model studies of PAH and sepsis. The costs of these studies were funded through grants provided by the U.S. Department of Health and Human Services. The data from these studies in both PAH and sepsis are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for each of these diseases.
In the animal model study of PAH, R-107 was demonstrated to be the first and only drug to produce a durable reversal, or potential cure, of this lethal disease. PAH is a lethal condition, with no cure, resulting from high blood pressure in the lungs. The worldwide market for treatment of PAH exceeds $6 billion per year and is projected to grow to $9.8 billion by 20271.
R-107 is a proprietary drug 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.
Closing of First Tranche of Financing with Alumina Partners (Ontario) Ltd.
Effective January 27, 2022, the Company closed the initial tranche of CAD $150,000 under its previously announced financing agreement with Alumina. The terms of the initial tranche were as previously announced. The closing of the initial tranche was made on the conditional approval of the initial tranche by the TSX Venture Exchange (the “TSXV”). The company is seeking final approval from the TSXV with respect to this initial tranche and expects to receive such final approval shortly. The net proceeds from the initial tranche were spent primarily for costs associated with the Company’s Phase 1 clinical study of R-107.