US 12,421,321 B2
Methods for treating fibrodysplasia ossificans progressiva
Pankaj Bhargava, Redwood City, CA (US); and Victoria Smith, Burlingame, CA (US)
Assigned to Ashibio, Inc., Brisbane, CA (US)
Filed by Ashibio, Inc., Brisbane, CA (US)
Filed on Jan. 22, 2025, as Appl. No. 19/034,098.
Application 19/034,098 is a continuation of application No. PCT/US2024/049868, filed on Oct. 3, 2024.
Claims priority of provisional application 63/699,035, filed on Sep. 25, 2024.
Claims priority of provisional application 63/542,679, filed on Oct. 5, 2023.
Prior Publication US 2025/0163184 A1, May 22, 2025
Int. Cl. C07K 16/40 (2006.01); A61P 19/00 (2006.01); A61P 21/00 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/40 (2013.01) [A61P 19/00 (2018.01); A61P 21/00 (2018.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01); C07K 2317/56 (2013.01)] 15 Claims
 
1. A method of treating a genetic heterotopic ossification (gHO) condition in a human subject to reduce or inhibit heterotopic ossification (HO), the method comprising:
administering to the human subject an anti-MMP-9 antibody or an antigen-binding fragment thereof comprising a heavy chain variable region (VH) comprising a heavy chain complementarity determining region 1 (HCDR1) comprising the amino acid sequence of SEQ ID NO: 8, an HCDR2 comprising the amino acid sequence of SEQ ID NO: 9, and an HCDR3 comprising the amino acid sequence of SEQ ID NO: 10, and a light chain variable region comprising a light chain complementarity determining region 1 (LCDR1) comprising the amino acid sequence of SEQ ID NO: 11, an LCDR2 comprising the amino acid sequence of SEQ ID NO: 12, and an LCDR3 comprising the amino acid sequence of SEQ ID NO: 13,
wherein the anti-MMP-9 antibody or antigen-binding fragment thereof is administered to the human subject via subcutaneous administration about every week to every two weeks at a dose of from 15 mg to 150 mg, adjusted for age group, wherein the human subject is aged from about 2 years to under 30 years and having a mutation predisposing the human subject to fibrodysplasia ossificans progressiva (FOP); and
wherein administration of the anti-MMP-9 antibody or antigen-binding fragment reduces or inhibits heterotopic ossification (HO) in the subject.