US 11,931,365 B2
Use of PPAR-delta agonists in the treatment of disease
Niall O′Donnell, San Diego, CA (US); Lynn Purkins, San Diego, CA (US); and Alejandro Dorenbaum, San Diego, CA (US)
Assigned to RENEO PHARMACEUTICALS, INC., Irvine, CA (US)
Filed by Reneo Pharmaceuticals, Inc., Irvine, CA (US)
Filed on Jan. 25, 2023, as Appl. No. 18/101,527.
Claims priority of provisional application 63/391,429, filed on Jul. 22, 2022.
Claims priority of provisional application 63/302,894, filed on Jan. 25, 2022.
Prior Publication US 2023/0233570 A1, Jul. 27, 2023
Int. Cl. A61K 31/5375 (2006.01); A61K 45/06 (2006.01); A61P 21/00 (2006.01)
CPC A61K 31/5375 (2013.01) [A61K 45/06 (2013.01); A61P 21/00 (2018.01)] 14 Claims
OG exemplary drawing
 
1. A method for treating a primary mitochondrial myopathy (PMM) in a human comprising orally administering to the human with PMM a solid form pharmaceutical composition comprising about 100 mg of crystalline sodium (E)-2-(4-((3-(4-fluorophenyl)-3-(4-(3-morpholinoprop-1-yn-1-yl)phenyl)allyl)oxy)-2-methylphenoxy)acetate (Compound II), wherein the human with PMM has at least one mutation or deletion in at least one mitochondrial DNA (mtDNA) gene; at least one mitochondrial DNA (mtDNA) defect; at least one mutation or deletion in at least one nuclear DNA (nDNA) gene involved in mitochondrial function; or a combination thereof; and wherein crystalline Compound II is characterized as having an XRPD pattern with peaks at 2.8±0.2° 2-Theta, 7.2±0.2° 2-Theta, 13.4±0.2° 2-Theta, 17.8±0.2° 2-Theta, 19.7±0.2° 2-Theta, 19.9±0.2° 2-Theta, and 20.6±0.2° 2-Theta as measured using Cu Kα radiation (crystalline Form 1).