US 12,168,041 B2
Methods and compositions for CNS delivery of arylsulfatase A
Nazila Salamat-Miller, Arlington, MA (US); Katherine Taylor, Arlington, MA (US); Paul Campolieto, Charlottesville, VA (US); Zahra Shahrokh, Weston, MA (US); Jing Pan, Boxborough, MA (US); Lawrence Charnas, Natick, MA (US); Teresa Leah Wright, Lexington, MA (US); and Pericles Calias, Melrose, MA (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Filed on Mar. 24, 2020, as Appl. No. 16/828,731.
Application 16/828,731 is a continuation of application No. 15/684,568, filed on Aug. 23, 2017, granted, now 10,646,554.
Application 15/684,568 is a continuation of application No. 13/168,963, filed on Jun. 25, 2011, granted, now 9,770,410, issued on Sep. 26, 2017.
Claims priority of provisional application 61/495,268, filed on Jun. 9, 2011.
Claims priority of provisional application 61/476,210, filed on Apr. 15, 2011.
Claims priority of provisional application 61/442,115, filed on Feb. 11, 2011.
Claims priority of provisional application 61/435,710, filed on Jan. 24, 2011.
Claims priority of provisional application 61/387,862, filed on Sep. 29, 2010.
Claims priority of provisional application 61/360,786, filed on Jul. 1, 2010.
Claims priority of provisional application 61/358,857, filed on Jun. 25, 2010.
Prior Publication US 2020/0405825 A1, Dec. 31, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/47 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 35/76 (2015.01); A61K 35/761 (2015.01); A61K 38/46 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01); C07K 14/65 (2006.01); C12N 9/24 (2006.01); C12N 9/42 (2006.01)
CPC A61K 38/47 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0085 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 35/76 (2013.01); A61K 35/761 (2013.01); A61K 38/46 (2013.01); A61K 38/465 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); C07K 14/65 (2013.01); C12N 9/2402 (2013.01); C12N 9/2437 (2013.01); C12Y 301/06008 (2013.01); C12Y 301/06013 (2013.01); C12Y 302/01045 (2013.01); C12Y 302/01046 (2013.01); C12Y 302/0105 (2013.01); C12Y 310/01001 (2013.01)] 6 Claims
OG exemplary drawing
 
1. A method of treating metachromatic leukodystrophy (MLD) comprising a step of administering directly into the cerebrospinal fluid of a subject in need of treatment a formulation comprising an arylsulfatase A (ASA) protein at a concentration at or greater than 10 mg/ml at a dose amount of at least 100 mg, salt, polysorbate, wherein the formulation comprises no greater than 10 mM phosphate, and wherein the formulation has a pH of between 5.5-6.5.