Abstract: There is provided a daily dosage regimen for treating pulmonary arterial hypertension. The regimen takes the form of two discrete dosage forms. Each dosage form includes an amount of about 600 mg to about 800 mg of (S)-ethyl 8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylate. There is also another method for providing a daily dosage regimen. There is also provided several methods for treating pulmonary arterial hypertension. There is provided a method for reducing the level of serotonin biosynthesis by at least 50%. There is also provided a method for achieving an AUC0-tau of ?2530 ng·hr/mL of (S)-8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylic acid. There is provided a method of achieving a >50% reduction in urinary 5-HIAA.

Abstract: There is a method of treating or preventing pulmonary arterial hypertension (PAH) or associated pulmonary arterial hypertension (APAH) in a patient. The method has the step of systemically administering to the patient a therapeutically effective amount of one or more compounds: (S)-ethyl 8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylate or a pharmaceutically acceptable salt thereof, or (S)-8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroeth-oxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylic acid or a pharmaceutically acceptable salt thereof, or a combination of the foregoing. There is also a method of treating or preventing PAH or APAH in a patient by systemically administering a therapeutically effective amount of a THP1 inhibitor from about 1 mg/kg/day to about 50 mg/kg/day. There is a method for treating PAH or APAH in a patient with a single daily dose.

Abstract: The invention is directed to a method for treating an inflammatory disorder of the lower airways in a human subject in need thereof, comprising administering an effective amount of a recombinant human IL-1 receptor antagonist (rhIL-IRa) directly to the lower airways in the human subject; wherein the inflammatory disorder is caused by a coronavirus infection.

Abstract: There is provided a daily dosage regimen for treating pulmonary arterial hypertension. The regimen takes the form of two discrete dosage forms. Each dosage form includes an amount of about 600 mg to about 800 mg of (S)-ethyl 8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylate. There is also another method for providing a daily dosage regimen. There is also provided several methods for treating pulmonary arterial hypertension. There is provided a method for reducing the level of serotonin biosynthesis by at least 50%. There is also provided a method for achieving an AUC0-tau of ?2530 ng·hr/mL of (S)-8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylic acid. There is provided a method of achieving a >50% reduction in urinary 5-HIAA.

Abstract: There is a daily dosage for treating pulmonary arterial hypertension (PAH) of two discrete dosage forms each having up to 600 mg of rodatristat ethyl or up to 1200 mg of rodatristat ethyl once per day. There are methods for treating PAH in human patients in need thereof via administration of the dosage forms. There is also a method for treating PAH via daily administration of an amount of a first compound of rodatristat ethyl and an amount of a second compound selected from among ambrisentan, sildenafil, tadalafil, bosentan, treprostinil, selexipag, macitentan, and a combination of two or more thereof. The combination results in an additive or synergistic reduction in symptoms or side effects of PAH compared to the two alone with a low risk for drug-drug interaction, such with a Cmax, unbound in the bloodstream of less than 0.028 ?M. The combination can also result in neither rodatristat ethyl nor its active metabolite rodatristat substantially impacting metabolism of the second compound in the bloodstream.

Abstract: A method for treating an inflammatory disorder of the lower airways in a human subject in need thereof is described, including administering an effective amount of anakinra directly to the lower airways in the human subject; where the effective amount of anakinra is from about 0.1 mg to about 200 mg per day; and where the inflammatory disorder is selected from the group consisting of a toxic-inhalation lung injury, pulmonary langerhans cell histiocytosis, non-cystic fibrosis bronchiectasis, diffuse panbronchiolitis, acute respiratory distress syndrome (ARDS), reactive airways dysfunction syndrome (RADS), bronchiolitis obliterans organizing pneumonia and pneumonitis.

Abstract: A pharmaceutical composition is disclosed, including: an interleukin-1 receptor antagonist, wherein the interleukin-1 receptor antagonist is a protein or a peptide; a buffer; and optionally one or more additional components each selected from the group consisting of a stabilizer and a tonicity modifier, wherein the pharmaceutical composition is adapted for administration via inhalation. Kits including the pharmaceutical composition of same and method of using same for treating an inflammatory disorder of lower airways in a human subject are also disclosed.

Abstract: There is provided a daily dosage regimen for treating pulmonary arterial hypertension. The regimen takes the form of two discrete dosage forms. Each dosage form includes an amount of about 600 mg to about 800 mg of (S)-ethyl 8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylate. There is also another method for providing a daily dosage regimen. There is also provided several methods for treating pulmonary arterial hypertension. There is provided a method for reducing the level of serotonin biosynthesis by at least 50%. There is also provided a method for achieving an AUC0-tau of ?2530 ng·hr/mL of (S)-8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylic acid. There is provided a method of achieving a >50% reduction in urinary 5-HIAA.

Abstract: This invention provides, among other things, novel compounds useful for treating protozoal infections, pharmaceutical compositions containing such compounds, as well as combinations of these compounds with at least one additional therapeutically effective agent.

Abstract: This invention provides, among other things, novel compounds useful for treating protozoal infections, pharmaceutical compositions containing such compounds, as well as combinations of these compounds with at least one additional therapeutically effective agent.