US 12,343,371 B2
Method for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using a sustained release depot formulation comprising glatiramer acetate
Uri Danon, Tel Aviv (IL); Nadav Bleich Kimelman, Tel Aviv (IL); Laura Popper, Tel Aviv (IL); and Ehud Marom, Tel Aviv (IL)
Assigned to MAPI PHARMA LTD., Ness Ziona (IL)
Filed by MAPI PHARMA LTD., Ness Ziona (IL)
Filed on Oct. 6, 2021, as Appl. No. 17/495,458.
Application 17/495,458 is a continuation of application No. 16/497,120, granted, now 11,167,003, previously published as PCT/IL2018/050340, filed on Mar. 25, 2018.
Claims priority of provisional application 62/476,794, filed on Mar. 26, 2017.
Prior Publication US 2022/0023377 A1, Jan. 27, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/00 (2006.01); A61K 9/00 (2006.01); A61K 38/02 (2006.01); A61K 47/34 (2017.01); A61P 25/00 (2006.01); A61P 25/28 (2006.01); A61K 38/10 (2006.01); A61K 38/16 (2006.01); A61K 39/00 (2006.01); C07K 14/47 (2006.01)
CPC A61K 38/02 (2013.01) [A61K 9/0024 (2013.01); A61K 47/34 (2013.01); A61P 25/00 (2018.01); A61P 25/28 (2018.01); A61K 38/10 (2013.01); A61K 38/16 (2013.01); A61K 39/0008 (2013.01); C07K 14/4713 (2013.01); G01N 2800/285 (2013.01)] 17 Claims
 
1. A method of suppressing or alleviating a symptom or a plurality of symptoms of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS) in a patient diagnosed with primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS), the method comprising administering or implanting a sustained release depot formulation comprising a 40 mg to 80 mg dose of glatiramer acetate to the patient, wherein the patient has been diagnosed with PPMS for at least 1 year and with signs of disease progression in the year prior to treatment, with a sustained increment in a rate of >1-point increase per year in the EDSS Expanded Disability Status Scale) score and has an EDSS score of between 2-5.5 or with a sustained increment in a rate of >0.5 point increase per year in the EDSS score and has an EDSS score of >5; and
wherein suppressing or alleviating a symptom or a plurality of symptoms of PPMS or SPMS comprises increasing the time to onset of 12 week Confirmed Disease Progression (CDP) of the patient assessed by the EDSS, compared to a baseline of the EDSS from the patient before the treatment or the EDSS from the untreated control patient.