Claritas Announces Letter of Intent to Acquire Exclusive Worldwide Rights to Develop R-107 for PAH - Seite 2

Mr. Farrell went on to say, “R-107 was evaluated in the same animal model of PAH in which the currently approved drugs for PAH were also tested. The results of this study were exceptional. R-107 was observed to be superior to all of the approved drugs in reducing pulmonary arterial blood pressure. R-107 was also seen to durably reverse disease severity after a short course of therapy. R-107 is the first and only drug to demonstrate the ability to reverse established disease. Based on these exceptionally positive and unique findings, we believe that R-107 could become a best-in-class, front-line therapy for PAH. If we 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. We will initiate and complete our Phase 1 clinical study this year, and we expect to complete a Phase 2 study of R-107 in the treatment of PAH in 2022.”

“With the addition of R-107 for treatment of PAH, Claritas will now have a two programs addressing large commercial markets. We are currently developing R-107 for treatment of viral infections, including vaccine-resistant COVID-19 infection, and now we will also have a potential breakthrough product that could provide unrivalled results in treatment of PAH.”

R-107 is Designed to Unlock the Potential of Nitric Oxide Therapy

Claritas is focusing on the therapeutic potential of nitric oxide because it is known to be safe and effective in the treatment of many diseases and disorders.

In 1992, Science magazine named nitric oxide molecule of the year; more than 130,000 peer reviewed articles have been published on nitric oxide; and nitric oxide was the subject of a 1998 Nobel Prize in medicine.

Claritas’ approach is to supplement the body’s natural nitric oxide with supplemental nitric oxide that will be delivered by the Company’s liquid, nitric oxide-releasing drug, R-107.

R-107 has several advantages over inhalable nitric oxide gas:

• Inhalable nitric oxide gas that is administered by inhalation therapy is quickly metabolized in the body, with a half-life of only 2-6 seconds. In contrast, R-107 delivers constant, sustained, therapeutic levels of nitric oxide throughout the body over a 24-hour period.
• Inhalable nitric oxide can only reach areas of the lungs with excellent ventilation. In patients with PAH, there are sections of the lungs that are poorly ventilated, which inhaled nitric oxide cannot reach. By contrast, R-107 delivers nitric oxide systemically, throughout the body and throughout the lungs, including areas of the lungs that are poorly ventilated.
• Inhalable nitric oxide gas is expensive and difficult to administer, requiring the use of specialized gas delivery systems that must be managed by trained respiratory therapists. In contrast, R-107 can simply and inexpensively be administered by injection or orally by capsule.