CLAS Claritas Pharmaceuticals Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that it will develop R-107 for the treatment of persistent pulmonary hypertension of the newborn (“PPHN”).

PPHN is fatal in up to 50% of newborn patients with this disorder, with up to 20% of surviving patients developing long term impairments such as hearing deficit, chronic lung disease, and intracranial bleeding.1 

Highlights 

• 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. One symptom is that the baby's skin is blue.
• Inhaled nitric oxide (“iNO”) is the only drug approved for the treatment of PPHN.
• 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.2
• Claritas believes that R-107, its liquid nitric oxide-releasing compound, 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.
• Claritas expects to initiate a Phase 2 study of R-107 in the treatment of PPHN by year-end 2022.
• Claritas’ development strategy for R-107 is designed to expedite the potential monetization of this asset.

PPHN

PPHN is a serious breathing problem in newborns. It usually happens in full-term babies or babies who were born at 34 weeks or more and occurs in approximately one of every 500 live births.

During pregnancy, the baby gets its oxygen from its mother and the placenta. Very little blood goes to the lungs because the blood vessels in the baby’s lungs are mostly closed. The blood vessels only open after birth when the baby takes his or her first breaths. The vessels then allow blood to travel to the lungs to get oxygen. PPHN occurs when the blood vessels do not open enough, which limits the amount of oxygen that is sent to the brain and organs. This is why PPHN is so dangerous.

Currently Approved Treatment for PPHN Is Inadequate

Inhaled nitric oxide (“iNO”) is the only approved drug for PPHN, and constitutes, alongside supportive therapy, the basis of its treatment. However, nearly 50% of infants are iNO-resistant, and do not respond to iNO treatment. This failure of iNO treatment in nearly half of all PPHN patients is believed to be due to the high level of oxidants in the infants’ lungs that inactivate nitric oxide.

Infants not responding to iNO are placed on an extracorporeal membrane oxygenation machine (“ECMO”), which is a modified heart lung bypass device that is associated with severe potential complications, including stroke, infection, and bleeding.

There is thus a major unmet medical need for a PPHN treatment that is effective in all infants with PPHN, so that the iNO non-responders can avoid the need for ECMO therapy.

R-107 Uniquely Delivers Nitric Oxide and Degrades Oxidants – Positioning R-107 as a Potential Frontline Treatment for PPHN

R-107 addresses the need for a treatment that could be effective in all PPHN patients by serving as a dual-function agent, both releasing nitric oxide as well as degrading oxidants. By combining both functions into a single drug, R-107 is ideally positioned to be the first agent to safely and effectively deliver nitric oxide to the oxidant-laden newborn lung.

Studies in numerous models of combined oxidant-based lung injury and pulmonary arterial hypertension have shown that R-107 therapy consistently relieves pulmonary hypertension even in settings where oxidant stress in the lung is severe. A Phase 2 clinical trial of R-107 in PPHN is now planned for late 2022. This study should position Claritas in the forefront of companies addressing this critically important orphan drug market, and, if the Phase 2 study is successful, Claritas will seek to monetize this program through either an out-license or sale.

Treatment of PPHN is a Large and Growing Commercial Market

Neonatal respiratory treatment is the major revenue contributor in the iNO market, with nearly all of the USD $634.4 million in 2019 revenues allocable to use of iNO in the treatment of PPHN, with such revenues projected to reach approximately USD $1,181 billion by 2027.3 These revenues are almost exclusively from iNO sales in developed countries, where the complex and expensive use of inhalation therapy for newborn patients is available.

In less developed countries, use of iNO in the treatment of PPHN is limited due to lack of facilities, equipment, funding, and the trained respiratory therapists required for administration of iNO to newborns. As a result, there is no broad-based economical and effective treatment for PPHN in these regions. Claritas believes that R-107 could address this issue, due in part to its ease of administration, and projected lower cost vis-à-vis iNO administration.

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

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Cautionary StatementsNeither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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 as a result of new information, future events or otherwise. 

Contact InformationRobert FarrellPresident, CEO(888) 861-2008info@claritaspharma.com

1 Ru-Jeng Teng, M.D. and Tzong-Jin Wu, M.D., Persistent Pulmonary Hypertension of the Newborn, J Formos Med Assoc. 2013 Apr; 112(4): 177–184, (Published online 2013 Jan 3. doi: 10.1016/j.jfma.2012.11.007) 2 Allied Market Research, Inhaled Nitric Oxide Market, 2021 3 Allied Market Research, Inhaled Nitric Oxide Market, 2021