Claritas Outlines Development Strategy for R-107 for Multiple Diseases, Disorders and Injuries

SAN FRANCISCO, CA and TORONTO, ON, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today outlined the Company's plans for developing R-107, the Company's nitric oxide-releasing compound, for multiple clinical indications.

Claritas' Development Strategy for R-107

"Claritas is poised to accelerate development of R-107 for treatment of numerous diseases, disorders and injuries," stated Robert Farrell, Claritas' President and CEO. "Our development strategy is straightforward, as follows:

• Phase 1 Study in Q1 2022: The first step is completion of our Phase 1 clinical study to demonstrate that R-107 is safe in humans. We expect to complete this study during Q1 this year.
  
  
• Multiple Phase 2 Studies in 2H 2022: Following completion of the Phase 1 study, we will initiate several Phase 2 clinical studies across multiple clinical indications, as follows:
  
  
  • COVID-Related Sepsis: Sepsis is the leading cause of death among COVID-19 patients, and, as we previously announced, a peer-reviewed article was recently published in Scientific Reports disclosing that R-107 effectively preserved multi-organ function in a sheep model of sepsis. These results suggest that R-107 could be a potentially revolutionary new treatment for sepsis. Based on these results, Claritas will initiate a Phase 2 clinical study to evaluate R-107 as a treatment for COVID-related sepsis and will apply for U.S. governmental grant funding to cover the costs of this study. The costs of the preclinical development of R-107 were covered by approximately USD $20 million of grant funding previously provided through the U.S. Department of Health and Human Services, and Claritas will again seek such funding for the costs of this Phase 2 study as well as the potential follow-on Phase 3 study. The worldwide market for treatment of sepsis was valued at more than USD $600 million in 2020 and is projected to grow to USD $1.6 billion by 2031.¹
    
    

• COVID-Related ARDS: Acute respiratory distress syndrome ("ARDS") is one of the common clinical manifestations of severe COVID-19. As we previously announced, a published study led by clinicians at Royal Brompton & Harefield NHS Foundation Trust² reported that inhaled nitric oxide significantly improved oxygen levels in patients with severe COVID-related ARDS. We believe that these data validate the potential of R-107 as a therapy for COVID-related ARDS, and, in Q3-Q4 2022, we will initiate a Phase 2 clinical study to evaluate R-107 as a treatment for COVID-related ARDS. We will apply for U.S. governmental grant funding to cover the costs of this study, as well as the potential follow-on Phase 3 study. According to an analysis by Reports and Data, the global ARDS market was valued at USD 583.8 million in 2018 and is expected to reach USD 934.8 million by the year 2026.
  
  
• PAH: Pulmonary arterial hypertension ("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 2027³. As we previously announced, R-107 is the first and only drug to demonstrate a durable reversal of established disease in a validated animal model of PAH. The data from this study are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for PAH. Claritas will initiate a Phase 2a clinical study of R-107 in hospitalized patients with PAH by mid-2022, which we expect to complete during Q4 2022.
  
  
• PPHN: Persistent pulmonary hypertension of the newborn ("PPHN") is one of the main causes of neonatal morbidity and mortality. PPHN is a serious condition, in which a newborn's lung vessels are not open wide enough, resulting in restricted blood flow and inability to absorb oxygen. Inhaled nitric oxide ("iNO") is the only drug approved for the treatment of PPHN, yet more than half of these neonatal patients do not respond and require emergent ECMO (lung bypass surgery), a therapeutic approach fraught with life-threatening complications. The global iNO market was valued at USD $634.4 million in 2019 and is estimated to reach approximately USD $1.181 billion by 2027, with most revenues allocable to treatment of PPHN.⁴ We believe that R-107 will be more effective than iNO in the treatment of PPHN and is ideally positioned to potentially become the new frontline therapy for the treatment of this disorder. We will initiate a Phase 2 study of R-107 in the treatment of PPHN by year-end 2022."
  
  

Additional Programs in RDS and Wound Healing

Mr. Farrell continued, "In addition to our programs in COVID-related sepsis, COVID-related ARDS, PAH and PPHN, we are also beginning work on a fifth program in which we will evaluate R-107 in treatment of respiratory distress syndrome ("RDS") in premature infants. We will shortly issue a separate press release providing details regarding the medical and business rationales for developing R-107 as a treatment for RDS."

"Additionally, we are negotiating to obtain exclusive worldwide rights to develop and commercialize R-107 for the treatment of skin ulcers and wound healing, including the treatment of severe burns. R-107 has potential to be a revolutionary new treatment for severe burns, and, if we successfully acquire these rights, we will apply for Orphan Drug Designation for R-107 in treatment of severe burns in pediatric patients. The worldwide market for an effective treatment for severe burns could exceed USD $1 billion annually. If our negotiations are successful, we expect that we will be able to acquire these rights sometime during Q1 2022."

Mr. Farrell concluded, "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 (vaginally or rectally) or topically (in an ointment). Depending on how it is administered, R-107 can target multiple diseases, disorders, and injuries. For example, we can administer R-107 through use of a nebulizer to target lung diseases, such as COVID-related sepsis and ARDS, and we can administer R-107 in an ointment to target wound healing, specifically burn wounds. Following completion of our initial Phase 2 studies in COVID-related sepsis and ARDS, as well as in PAH and PPHN, we plan to expand the development of R-107 to include the treatment of other disorders, including RDS, wound healing, diabetic ulcers, pressure ulcers, female sexual dysfunction, dysmenorrhea, anal fissures and acne."

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.

About Claritas Pharmaceuticals

Claritas Pharmaceuticals, Inc. ("Claritas") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing, and delivering innovative human therapeutics. Claritas focuses on areas of unmet medical need and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people's lives.

• Website Home: https://claritaspharma.com/
• News and Insights: https://claritaspharma.com/news/
• Investors: https://claritaspharma.com/investors
  
  

This press release may contain certain forward-looking information and statements ("forward-looking information") within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavorable results. Claritas undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Claritas believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be

inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Claritas' control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Claritas disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether because of new information, future events or otherwise. 

Contact Information
Robert Farrell
President, CEO
(888) 861-2008
[email protected]m

¹ Sepsis Treatment Market to Reach Valuation of US$ 1.6 Bn By 2031: Transparency Market Research, April 8, 2021

² Garfield B., McFadyen C., Briar C., Bleakley C., Viachou A., Baldwin M., et. al., British Journal of Anaesthesia, Volume 126, Issue 2, E72-E75, February 01, 2021,  
³ Pulmonary Arterial Hypertension Market Size Worth $9.8 Billion By 2027, Grand View Research, February 2020
⁴ Allied Market Research, Inhaled Nitric Oxide Market, 2021