US 12,029,780 B2
Long-acting polypeptides and methods of producing and administering same
Fuad Fares, Hourfish Village (IL); and Udi Eyal Fima, Dvira (IL)
Assigned to OPKO BIOLOGICS LTD., Kiryat Gat (IL)
Filed by OPKO BIOLOGICS LTD., Kiryat Gat (IL)
Filed on Dec. 13, 2021, as Appl. No. 17/549,017.
Application 17/549,017 is a division of application No. 15/200,813, filed on Jul. 1, 2016, granted, now 11,197,915.
Application 15/200,813 is a continuation of application No. 14/555,308, filed on Nov. 26, 2014, abandoned.
Application 14/555,308 is a continuation of application No. PCT/IL2014/050910, filed on Oct. 21, 2014.
Application PCT/IL2014/050910 is a continuation in part of application No. 14/059,134, filed on Oct. 21, 2013, abandoned.
Application PCT/IL2014/050910 is a continuation in part of application No. 14/309,496, filed on Jun. 19, 2014, abandoned.
Prior Publication US 2022/0241380 A1, Aug. 4, 2022
Int. Cl. A61K 38/27 (2006.01); A61K 38/24 (2006.01); A61K 47/00 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); C07K 14/475 (2006.01); C07K 14/505 (2006.01); C07K 14/555 (2006.01); C07K 14/59 (2006.01); C07K 14/61 (2006.01); C07K 19/00 (2006.01); G01N 33/74 (2006.01)
CPC A61K 38/27 (2013.01) [A61K 38/24 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); C07K 14/505 (2013.01); C07K 14/555 (2013.01); C07K 14/59 (2013.01); C07K 14/61 (2013.01); G01N 33/74 (2013.01); C07K 2319/00 (2013.01); C07K 2319/31 (2013.01); G01N 2333/65 (2013.01); G01N 2800/52 (2013.01)] 13 Claims
 
1. A method for maintaining insulin-like growth factor (IGF-1) levels in a growth hormone deficient human prepubertal pediatric subject within a normal therapeutic range, comprising
administering to the growth hormone deficient human prepubertal pediatric subject a therapeutically effective amount of a glycosylated polypeptide comprising an amino terminal chorionic gonadotropin carboxy terminal peptide (CTP) of SEQ ID NO:18, a human growth hormone polypeptide, and two carboxy terminal chorionic gonadotropin CTPs, each of SEQ ID NO:18 and arranged in tandem (CTP-modified hGH polypeptide), the CTP-modified hGH polypeptide having the amino acid sequence as set forth in amino acids 27 to 301 of SEQ ID NO: 39,
wherein the therapeutically effective amount comprises a once a week dose of 0.66 milligrams per kilogram per week_(mg/kg/week), and
wherein the normal therapeutic range of IGF-1 levels is ±2 standard deviations (SDS) of the average IGF-1 levels in non-growth hormone deficient human prepubertal pediatric subjects.