Invention Grant
- Patent Title: Modified fibroblast growth factor 21 (FGF-21) for use in methods for treating nonalcoholic steatohepatitis (NASH)
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Application No.: US16644839Application Date: 2018-09-06
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Publication No.: US11642395B2Publication Date: 2023-05-09
- Inventor: Edgar Davidson Charles, III , Rose C. Christian , Yi Luo
- Applicant: BRISTOL-MYERS SQUIBB COMPANY
- Applicant Address: US NJ Princeton
- Assignee: BRISTOL-MYERS SQUIBB COMPANY
- Current Assignee: BRISTOL-MYERS SQUIBB COMPANY
- Current Assignee Address: US NJ Princeton
- Agency: Nelson Mullins Riley & Scarborough LLP
- Agent Jane E. Remillard, Esq.; Jill Gorny Sloper, Esq.
- International Application: PCT/US2018/049729 2018.09.06
- International Announcement: WO2019/051073A 2019.03.14
- Date entered country: 2020-03-05
- Main IPC: A61K38/18
- IPC: A61K38/18 ; A61P1/16 ; A61K45/06 ; G01N33/68

Abstract:
Provided herein are methods for treating a patient having NASH who has been determined to have a particular threshold level of serum Pro-C3 (e.g., greater than 10 ng/ML) by administering to the patient a modified Fibroblast growth factor 21 (FGF-21) in an amount and with a frequency sufficient to treat NASH. Also provided are methods for monitoring responsiveness of a patient having NASH to treatment with a modified FGF-21, the method comprising: determining the serum Pro-C3 level in a blood sample from the patient obtained during or after treatment, wherein: a decreased serum Pro-C3 level in the blood sample from the patient obtained during or after treatment, as compared to the serum Pro-C3 level in a blood sample from the patient obtained prior to treatment with the modified FGF-21, indicates that the patient is responsive to treatment with the modified FGF-21.
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