More News !!!ORIGINAL: Claritas to Develop R-107 for Treatment of PPHN, a Potentially Fatal Pulmonary Disorder in Newborns 2021-12-22 07:15 ET - News Release SAN FRANCISCO, CA, and TORONTO, ON, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc.(TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas")today announcedthat 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 whicha newbornslung vessels are not open wide enough,resulting in restrictedblood flowand inability to absorb oxygen.One symptom is that the baby's skin is blue.Inhaled nitric oxide (iNO) isthe onlydrug approved for the treatment ofPPHN.The global iNOmarket wasvalued atUSD$634.4 million in 2019and is estimated to reachapproximately USD$1,181 billion by 2027, withmostrevenues allocable to treatment of PPHN.2Claritasbelieves thatR-107, its liquid nitric oxide-releasing compound,willbe more effective than iNO in the treatment of PPHN, andis ideally positioned to potentially becomethenew frontline therapy for the treatment ofthis disorder.Claritasexpects to initiateaPhase 2 study of R-107 inthetreatment ofPPHN 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 babys 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. CurrentlyApprovedTreatment for PPHNIsInadequate 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 2019revenues allocable to use of iNO in the treatment of PPHN, with such revenues projected to reach approximately USD $1,181 billion by 2027.3These 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--vis iNO administration.