Claims for Patent: 10,363,235

Summary for Patent: 10,363,235

Title:	Compositions comprising 15-HEPE and methods of treating or preventing fibrosis using same
Abstract:	The present disclosure provides compositions comprising 15-HEPE and methods of using same for treating and/or preventing fibrosis in a subject in need thereof.
Inventor(s):	Rowe; Jonathan (Waterford, CT), Duffy; Kevin (Dublin, IE), Climax; John (Dublin, IE)
Assignee:	Afimmune Limited (IE)
Application Number:	15/062,636
Patent Claims:	1. A method of reducing or preventing fibrosis in a subject in need thereof, the method comprising; identifying the subject as having or as having an increased risk for developing fibrosis associated with an organ or tissue selected from the group consisting of: liver, heart, mediastinum, bone marrow, retroperitoneaum, skin, intestine, joint, and a reproductive organ, or a combination thereof; and, based on the identification, administering to the subject a composition comprising 15-HEPE wherein the 15-HEPE represents at least 80% by weight of all fatty acids in the pharmaceutical composition. 2. The method of claim 1, wherein the fibrosis is liver fibrosis. 3. The method of claim 1, wherein the fibrosis is associated with non-alcoholic fatty liver disease (NAFLD). 4. The method of claim 3, wherein a NAFLD activity score (NAS) is reduced in the subject after administration of the composition. 5. The method of claim 4, wherein the NAS is reduced in the subject compared to baseline. 6. The method of claim 4, wherein the NAS is reduced in comparison to a second subject who has not been administered the composition. 7. The method of claim 6, wherein the second subject has been administered a placebo. 8. The method of claim 6, wherein the second subject is on fibrosis therapy. 9. The method of claim 8, wherein the fibrosis therapy comprises administration of a hepatitis C virus (HCV) non-antiviral agent, an HCV antiviral agent, a hepatitis B virus (HBV) non-antiviral agent, an HBV antiviral agent, a primary biliary cirrhosis agent, an alcoholic hepatitis agent, a primary sclerosing cholangitis agent, a NASH agent, an autoimmune hepatitis agent, a pulmonary fibrosis agent, a cystic fibrosis agent, a renal fibrosis agent, a skin fibrosis agent, a myelofibrosis agent, an eosinophilic esophagitis agent, an anti-TGF-.beta. agent, an anti-CTGF agent, a recombinant human serum amyloid P agent, an anti-IL-4 agent, an anti-IL-5 agent (e.g., mepolizumab), an anti-IL-13 agent, a neurochemical receptor agent, an anti-IL-17A agent, a Hh or Hh(R) SMO antagonist, a CCR5 antagonist, a CCR4 cell recruitment inhibitor, a CXCR4 antagonist, an anti-CXCR4 agent, a CXCR3 antagonist, an anti-CCL17 agent, a NOX inhibitor, copaxone, adiponectin, an AMPK agonist, Y-box binding protein-1, a myofibroblast recruitment inhibitor, an anti-Th17 MMP inducer, an anti-extracellular matrix deposition compound, an adenosine receptor antagonist, a micro-RNA (miR) agent, a stem cell, tenofovir, an anti-collagen crosslinking agent (e.g., simtuzumab, mogamulizumab), or an angiotensin II receptor blocker (ARB) selected from the group consisting of: valsartan, telmisartan, losartan, irbesartan, azilsartan, eprosartan, olmesartan, or a combination of any of the foregoing. 10. The method of claim 1, wherein the subject is on fibrosis therapy. 11. The method of claim 10, wherein the fibrosis therapy is continued during administration of the 15-HEPE or the composition. 12. The method of claim 1, wherein the 15-HEPE or the composition is orally administered. 13. The method of claim 1, wherein the 15-HEPE is in free acid form. 14. The method of claim 1, wherein the 15-HEPE is in esterified form. 15. The method of claim 14, wherein the esterified form is an alkyl ester form. 16. The method of claim 14, wherein the esterified form is a triglyceride form. 17. The method of claim 1, wherein the 15-HEPE is in salt form. 18. The method of claim 1, wherein the 15-HEPE comprises 15(S)-HEPE. 19. The method of claim 1, wherein the 15-HEPE comprises 15(R)-HEPE.

Details for Patent 10,363,235

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	11/04/2015		2034-12-02
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526	06/06/2019		2034-12-02
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526	01/22/2022		2034-12-02