AU2025205402A1 — New oral pharmaceutical composition and dose regimen for the therapy of progressive fibrosing interstitial lung diseases

USPTO Abstract

#$%^&*AU2025205402A120250731.pdf##### NEW ORAL PHARMACEUTICAL COMPOSITION AND DOSE REGIMEN FOR THE THERAPY OF PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASES Abstract The invention concerns an oral pharmaceutical composition consisting essentially of the PDE4B-inhibitor of formula (III) in the dose of 18 mg or 9 mg and optionally of one or more pharmaceutically acceptable carriers or excipients for use in the treatment of a patient suffering from one or more progressive fibrosing interstitial lung diseases (PF-ILD), wherein this oral pharmaceutical composition is to be administered to the patient twice daily. The invention further concerns oral pharmaceutical compositions comprising the PDE4B-inhibitor of formula (III) in the dose of 18 mg or 9 mg and a therapeutically effective dose of a second active ingredient selected from nintedanib or pirfenidone, wherein these oral pharmaceutical compositions are administered to the patient twice daily. NEW ORAL PHARMACEUTICAL COMPOSITION AND DOSE REGIMEN FOR THE THERAPY OF PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASES Abstract R R* S. N Q R² N N RN R® OR¹ (I) The invention concerns an oral pharmaceutical composition consisting essentially of the PDE4B-inhibitor of formula (III) in the dose of 18 mg or 9 mg and optionally of one or more pharmaceutically acceptable carriers or excipients for use in the treatment of a patient suffering from one or more progressive fibrosing interstitial lung diseases (PF-ILD), wherein this oral pharmaceutical composition is to be administered to the patient twice daily. The invention further concerns oral pharmaceutical compositions comprising the PDE4B-inhibitor of formula (III) in the dose of 18 mg or 9 mg and a therapeutically effective dose of a second active ingredient selected from nintedanib or pirfenidone, wherein these oral pharmaceutical compositions are administered to the patient twice daily. 20 25 20 54 02 11 J ul 2 02 5 N E W O R A L P H A R M A C E U T I C A L C O M P O S I T I O N A N D D O S E R E G I M E N F O R T H E T H E R A P Y O F P R O G R E S S I V E F I B R O S I N G I N T E R S T I T I A L 2 0 2 5 2 0 5 4 0 2 1 1 J u l 2 0 2 5 L U N G D I S E A S E S A b s t r a c t R R * S . N Q R ² N N R N R ® 0 R ¹ (I ) T h e i n v e n t i o n c o n c e r n s a n o r a l p h a r m a c e u t i c a l c o m p o s i t i o n c o n s i s t i n g e s s e n t i a l l y o f t h e P D E 4 B - i n h i b i t o r o f f o r m u l a ( I I I ) i n t h e d o s e o f 1 8 m g o r 9 m g a n d o p t i o n a l l y o f o n e o r m o r e p h a r m a c e u t i c a l l y a c c e p t a b l e c a r r i e r s o r e x c i p i e n t s f o r u s e i n t h e t r e a t m e n t o f a p a t i e n t s u f f e r i n g f r o m o n e o r m o r e p r o g r e s s i v e f i b r o s i n g i n t e r s t i t i a l l u n g d i s e a s e s ( P F - I L D ) , w h e r e i n t h i s o r a l p h a r m a c e u t i c a l c o m p o s i t i o n i s t o b e a d m i n i s t e r e d t o t h e p a t i e n t t w i c e d a i l y . T h e i n v e n t i o n f u r t h e r c o n c e r n s o r a l p h a r m a c e u t i c a l c o m p o s i t i o n s c o m p r i s i n g t h e P D E 4 B - i n h i b i t o r o f f o r m u l a ( I I I ) i n t h e d o s e o f 1 8 m g o r 9 m g a n d a t h e r a p e u t i c a l l y e f f e c t i v e d o s e o f a s e c o n d a c t i v e i n g r e d i e n t s e l e c t e d f r o m n i n t e d a n i b o r p i r f e n i d o n e , w h e r e i n t h e s e o r a l p h a r m a c e u t i c a l c o m p o s i t i o n s a r e a d m i n i s t e r e d t o t h e p a t i e n t t w i c e d a i l y .