Method for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using a sustained release depot formulation comprising glatiramer acetate
Inventors
DANON, Uri • BLEICH KIMELMAN, Nadav • POPPER, Laura • Marom, Ehud
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12343371-B2
Publication Date
2025-07-01
Expiration Date
Abstract
The present invention provides methods for treating or ameliorating primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS) and related symptoms by administering or implanting a depot formulation comprising glatiramer salts, such as glatiramer acetate (GA).
Core Innovation
The disclosed invention relates to depot formulations for long-acting treatment of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS). It provides a method of suppressing or alleviating a symptom or a plurality of symptoms by administering or implanting a sustained release depot formulation comprising glatiramer acetate (GA), including glatiramer acetate at a specified dose range, as a depot therapy intended to deliver sustained release.
The described approach is grounded in treating PPMS and SPMS patients with documented disease progression and defined disability status. The depot treatment is associated with increasing the time to onset of 12 week Confirmed Disease Progression (CDP) assessed by the EDSS, compared to baseline EDSS or an untreated control, and is additionally evaluated using whole brain volume change and cortical volume change, together with Timed 25-foot walk (T25FW) and 9-Hole Peg Test (9-HPT), and MRI lesion measures including T2/T1 and gadolinium (Gd)-enhancing lesions.
The disclosed formulations include depot delivery systems using carriers/diluent and polymer encapsulation, including poly(lactide-co-glycolide) (PLGA) as an encapsulation component to form microspheres that provide sustained release characteristics over weeks. The document further describes comparative and supporting rationale, including in vivo evaluation in a progressive EAE model and a Phase IIa open-label human study of once-monthly intramuscular GA depot, with safety/tolerability and endpoints including EDSS/CDP and MRI outcomes.
Claims Coverage
The independent claim clm-00001 defines a method of suppressing or alleviating symptoms of PPMS or SPMS using administration or implantation of a sustained release depot formulation comprising 40 mg to 80 mg glatiramer acetate. The claim requires specific patient diagnosis/progression criteria and defines symptom alleviation in terms of increasing time to onset of 12 week Confirmed Disease Progression (CDP) assessed by EDSS versus baseline or untreated control.
Sustained release depot formulation with specified GA dose
Administering or implanting a sustained release depot formulation comprising a 40 mg to 80 mg dose of glatiramer acetate to a patient diagnosed with PPMS or SPMS.
Patient with documented PPMS/SPMS progression and EDSS thresholds
The patient has been diagnosed with PPMS for at least 1 year and shows 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 (EDSS) score and an EDSS score of between 2-5.5, or with a sustained increment in a rate of >0.5 point increase per year and an EDSS score of >5.
Symptom alleviation via increased time to 12 week Confirmed Disease Progression
Suppressing or alleviating a symptom or plurality of symptoms comprises increasing the time to onset of 12 week Confirmed Disease Progression (CDP) of the patient assessed by EDSS, compared to baseline EDSS from the patient before treatment or EDSS from an untreated control patient.
Overall, the claim coverage centers on a sustained-release GA depot (40–80 mg) provided to PPMS/SPMS patients with defined progression and EDSS thresholds, where the therapeutic effect is characterized by increased time to onset of 12-week CDP measured by EDSS versus baseline or untreated control.
Stated Advantages
Increasing the time to onset of 12 week Confirmed Disease Progression (CDP) assessed by EDSS versus baseline or an untreated control patient.
Suppressing or alleviating a symptom or a plurality of symptoms of PPMS or SPMS.
Documented Applications
Treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) using a sustained release depot formulation comprising glatiramer acetate.
Assessment of clinical outcomes in a Phase IIa open-label human study using once-monthly 40 mg intramuscular GA depot, including safety/tolerability and EDSS/CDP plus MRI endpoints.
Evaluation in a progressive EAE model (MOG-induced progressive EAE/PP-EAE model) comparing GA depot versus a Copaxone®-related comparator and measuring relevant outcomes [procedural detail omitted for safety].
Interested in licensing this patent?