Claritas Pharmaceuticals, Inc. Announces Additional Data in Validated Animal Model of PAH Demonstrating Ability of R-107 to Prevent, Treat, and Reverse Established Disease
July 21, 2021 at 07:18 am EDT
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Claritas Pharmaceuticals, Inc. provided additional detail regarding exceptionally positive data with R-107 in a validated animal model of pulmonary arterial hypertension ("PAH"). These data are unprecedented in the scientific literature, and suggest that R-107 is a potentially revolutionary new treatment for PAH. As previously disclosed, R-107 was evaluated 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. Following are additional details regarding these data: Prevention of Disease Progression: The data demonstrate that R-107 therapy halts the otherwise unstoppable progression of PAH. The level of protection was total, i.e., administration of R-107 stopped all further vascular damage and hypertensive disease. This is a critical benefit because PAH is a lethal disease, inexorably worsening until death from heart failure. Although existing drugs for treatment of PAH may reduce the severity of symptoms and provide a modestly improved quality of life, they do not meaningfully slow the progression of the disease, i.e., they are not fundamentally disease modifying. R-107 is thus poised to be the first therapeutic agent to transform PAH from a lethal condition to a chronic treatable disease that can be stabilized and lived with
long-term. Immediate and Near-Total Relief of Acute Symptoms: The data demonstrate that R-107 provides immediate and near total relief of the life-threatening symptoms of acute PAH. Rats treated with R-107 reproducibly responded within minutes of R-107 administration, as revealed by a prompt and near total fall in pulmonary blood pressure. In contrast, in the same animal model system, existing marketed drugs for treatment of PAH, such as sildenafil and bosentan, provide at best only half of this potency. Further, R-107 offered relief for a full 24 hours after a single dose, whereas sildenafil and bosentan were effective for a much shorter interval. Thus, R-107 is poised
to be the most potent and long-lasting agent for relief of the life-threatening symptoms of acute PAH. Reversal (Potential Cure) of Disease: R-107 appears to be the first drug that can actually reverse PAH, i.e., it remodels the lung so that it returns to normal function, and normal function is maintained even after treatment with R-107 is completed. Whereas existing drugs for treatment of PAH can lower pulmonary blood pressure transiently, they cannot turn back the clock on patients with established severe disease. In the gold-standard rat model of the disease in which R-107 was tested, the introduction of a 2-week pulse of R-107 therapy in animals with well-established PAH resulted in a 75% reduction in blood pressure elevation that persisted, even days after R-107 therapy was concluded. Such results are, to the best of knowledge, unprecedented in the scientific literature. Successful translation of these results in rodents to a clinical population would herald that patients with severe PAH could obtain a cure of existing well-established lethal disease. Superior Safety Profile: R-107 appears to be safer than existing drugs for treatment of PAH.
Phosphodiesterase 5 inhibitors, such as sildenafil, and endothelin receptor antagonists, such as bosentan, have myriad unwelcome side effects, including liver injury, flushing, dizziness, nasal congestion, and penile erection. In contrast, formal FDA-mandated toxicology and safety pharmacology studies of R-107 have demonstrated to date that the drug is extremely well tolerated. R-107 is a liquid nitric oxide-releasing compound 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.
Claritas Pharmaceuticals, Inc., formerly Kalytera Therapeutics Inc, is a biotechnology company that is focused on developing R-107 for the treatment of vaccine-resistant coronavirus disease (COVID) strains. The Companyâs products in development include R-107 for coronavirus disease and Viral Infections, R-107 and Vaccines, and CLA-1816 for treatment of pain. R-107 is designed to defeat COVID viruses on contact. R-107 targets the Achilles heel of COVID, the spike protein on the surface of the virus. R-107 releases nitric oxide, which attaches to a specific amino acid on the spike protein, thereby disabling the spike protein. The CLA-1816 provides effective pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. CLA-1816 strongly binds with and activates the alpha3 glycine pain receptor in the spine. The Company has leased a laboratory, office, and archival space in Beverly, Massachusetts.
Claritas Pharmaceuticals, Inc. Announces Additional Data in Validated Animal Model of PAH Demonstrating Ability of R-107 to Prevent, Treat, and Reverse Established Disease