glatiramer acetate once-a-month depot (GA depot) / Viatris, Mapi Pharma - LARVOL DELTA

Glatiramer Acetate Depot Extended-Release Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety & Efficacy Snapshot Interim Analysis (ACTRIMS Forum 2025) - "This interim analysis suggests that GA Depot is a safe and potentially effective treatment for PPMS patients, showing a low rate of AEs and stable disability outcomes. Additionally, the data also suggests a favorable trend in safety and tolerability for the 25 mg dose of GA Depot compared to the 40 mg dose while maintaining similar efficacy. These findings support further investigation in a global controlled double blind phase III study."

Clinical • P2a data • CNS Disorders • Multiple Sclerosis

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS (clinicaltrials.gov) - P1/2 | N=25 | Completed | Sponsor: Mapi Pharma Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Patient-Reported Outcome Results From the Open-Label Period of Glatiramer Acetate Depot Phase 3 Study in Patients With Relapsing Forms of Multiple Sclerosis (CMSC 2024) - "In OL period completers, patient-reported outcomes remained stable or improved for most patients who were treated with GA Depot and high treatment satisfaction was also reported (> 90% of subjects satisfied with treatment). This further consolidated GA Depot’s favorable safety and tolerability profile established in the PC period, and positioned GA Depot as a safe and convenient treatment option that may increase treatment adherence in patients with RMS."

Clinical • P3 data • Patient reported outcomes • CNS Disorders • Depression • Mood Disorders • Multiple Sclerosis • Pain • Psychiatry

Glatiramer Acetate Depot (Extended Release) Phase 2a Study in Patients With Primary Progressive Multiple Sclerosis: Safety and Efficacy Snapshot (CMSC 2024) - "These interim snapshot findings suggest GA depot as a safe and effective treatment for patients with PPMS, with a remarkable 72.4% NEP, stable EDSS score, and high proportion of stable T25FW and 9HPT scores once treated. GA depot 25 mg shows a favorable trend in efficacy, with improved safety and tolerability. These results encourage further exploration during the ongoing study, emphasizing the potential of GA depot to address the continuous neurological decline in PPMS."

Clinical • P2a data • CNS Disorders • Multiple Sclerosis

The Efficacy of Glatiramer Acetate Depot in Patients With Relapsing Forms of Multiple Sclerosis: Subgroup Analyses of Phase 3 Study (CMSC 2024) - P3 | "Subgroup analyses showed that patients with relapsing forms of MS with wide-ranging demographic and disease characteristics can potentially benefit from GA depot, and the results are consistent with the primary analysis of the overall population."

Clinical • P3 data • CNS Disorders • Multiple Sclerosis

Patient Reported Outcomes, Safety and Tolerability in the Open Label Period of GA Depot, Phase 3, Multinational, Double-Blind, Placebo-Controlled Study in Patients With Relapsing Forms of Multiple Sclerosis (ACTRIMS Forum 2024) - "Background: Glatiramer Acetate Depot (GA Depot) is a novel long-acting GA formulation consisting of extended-release microspheres containing GA, administered IM every 28 days... Patient reported outcomes remained stable or improved during the OL period for all patients treated with GA Depot. The high treatment satisfaction (>90% of subjects satisfied with treatment) and the safety observed in the OL period consolidate GA Depot's favorable safety and tolerability profile established in the PC period, positioning GA Depot as a safe and convenient treatment option that may increase treatment adherence in RMS patients."

Clinical • P3 data • Patient reported outcomes • CNS Disorders • Depression • Infectious Disease • Mood Disorders • Multiple Sclerosis • Novel Coronavirus Disease • Pain • Psychiatry

Safety and Tolerability of Glatiramer Acetate Depot: Results of Phase III Open Label period (ACTRIMS Forum 2024) - "Results from the OL period support the good safety and tolerability profile of GA Depot in patients with RMS. Furthermore, continued treatment reduced overall incidence of AEs, including those leading to discontinuation. The favorable long-term safety profile of GA Depot, with its more convenient administration regimen of once every 4 weeks, can enhance treatment adherence, and optimize patient care of people with RMS."

Clinical • P3 data • CNS Disorders • Hematological Disorders • Infectious Disease • Influenza • Multiple Sclerosis • Pain • Respiratory Diseases

Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Mapi Pharma Ltd.

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Mapi Pharma Ltd.

Trial completion date • CNS Disorders • Multiple Sclerosis

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS (clinicaltrials.gov) - P3 | N=1016 | Completed | Sponsor: Mapi Pharma Ltd. | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial primary completion date • CNS Disorders • Multiple Sclerosis

Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Mapi Pharma Ltd. | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2

Enrollment closed • Phase classification • CNS Disorders • Multiple Sclerosis

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Mapi Pharma Ltd. | Phase classification: P2a ➔ P1/2

Phase classification • CNS Disorders • Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis (PRNewswire) - "Viatris Inc...and Mapi Pharma Ltd...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies' recently submitted New Drug Application (NDA) for GA Depot 40 mg. The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 8, 2024....The GA Depot NDA filing is supported by results from a multinational, double blind, placebo-controlled Phase III clinical trial evaluating the efficacy, safety and tolerability of GA Depot compared with placebo in patients with RMS."

NDA • PDUFA date • CNS Disorders • Immunology • Multiple Sclerosis

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS (clinicaltrials.gov) - P3 | N=1016 | Completed | Sponsor: Mapi Pharma Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Viatris and Mapi Pharma to Highlight Latest Results of Multiple Sclerosis Research at American Academy of Neurology 75th Annual Meeting (PRNewswire) - P3 | N=1016 | NCT04121221 | Sponsor: Mapi Pharma Ltd. | "Viatris...today announced that recent data from ongoing studies of GA Depot 40 mg will be presented at the American Academy of Neurology (AAN) 75th Annual Meeting in Boston taking place April 22-27. Data will include results from the pivotal Phase III clinical trial exploring the efficacy and safety of GA Depot – a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS)."

P3 data • CNS Disorders • Multiple Sclerosis

Results of a Phase III, Multinational, Double Blind, Placebo-Controlled Study in Subjects with Relapsing Forms of Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of GA Depot, a Long-Acting IM Injection of Glatiramer Acetate, Administered Once Every Four Weeks (ACTRIMS Forum 2023) - "Background: GA Depot (Glatiramer Acetate Depot) consists of extended-release microspheres administered intramuscularly every 28 days... The significant treatment effect of GA Depot in reducing ARR (30%, p=0.0066), strengthened by MRI endpoints, supports the use of GA Depot as a disease modifying therapy for RMS patients. GA Depot offers a preferable schedule than current regimens of GA, potentially leading to improved patient satisfaction and treatment. GA Depot administration regime is expected to result in fewer ISRs than other GA products.Study Supported by: Mapi Pharma Ltd Disclosure: Aaron Miller is the Coordinating PI of the study."

Clinical • P3 data • CNS Disorders • Multiple Sclerosis

Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS) (GlobeNewswire) - P3 | N=1016 | NCT04121221 | Sponsor: Mapi Pharma Ltd. | "Mapi Pharma...announced today positive top-line results from the GA Depot (a long acting glatiramer acetate) Phase III clinical trial assessing the efficacy, safety and tolerability of a once monthly GA Depot 40 mg compared to placebo in relapsing forms of multiple sclerosis (RMS) patients. Top-line efficacy results showed that GA Depot 40 mg meet the primary endpoint versus placebo in significantly reducing the ARR. The one-year multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo-controlled study in subjects with relapsing forms of multiple sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, IM injection once monthly recruited 1,016 patients at 112 multinational sites."

P3 data: top line • CNS Disorders • Multiple Sclerosis

Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy 1 Year Interim Snapshot Analysis (CMSC 2022) - "These 1-year interim snapshot data suggest that GA Depot is a safe and effective treatment for patients with PPMS, based on the low rate of AEs detected and the stable EDSS for both man and woman, no 12 weeks confirmed disability progression (CDP) that contributed to a high NEP (69.2%) disability measures observed. These results encourage us to test GA Depot in controlled global double blind phase III study."

Clinical • Late-breaking abstract • P2a data • CNS Disorders • Multiple Sclerosis

Mapi Pharma Receives U.S. Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive Multiple Sclerosis with a Sustained Release Glatiramer Acetate Depot (GlobeNewswire) - "Mapi Pharma...announced today that the company has been granted U.S. Patent No. 11,167,003 entitled: 'Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis (PPMS or SPMS) using sustained release glatiramer depot systems.'...GA Depot is currently in the final stages of a multinational Phase III clinical study where it is being evaluated for treatment of relapsing forms of multiple sclerosis (RMS). GA Depot is also currently being evaluated in a multinational Phase II for primary progressive multiple sclerosis (PPMS)....Based on the initial efficacy and safety results in the ongoing Phase II study in PPMS and the patent protection, the company is seeking a partner to support the Phase III development and co-marketing of GA Depot for PPMS. Mapi will present two posters featuring clinical data on GA Depot in RRMS and PPMS at the forthcoming American Academy of Neurology annual meeting, to take place April 2 – 7, 2022."

Patent • CNS Disorders • Multiple Sclerosis

Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy Snapshot (AAN 2022) - "These interim snapshot data suggest that GA Depot is a safe and effective treatment for patients with PPMS, as demonstrated by stable mean EDSS, mean 9HPT and mean T25FW data, which encourage us to continue this on-going investigation."

Clinical • P2a data • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Glatiramer acetate depot (extended-release) phase IIa study in patients with primary progressive multiple sclerosis: safety and efficacy snapshot (ECTRIMS 2021) - "These interim snapshot data suggest that GA Depot is possibly a safe and effective treatment for patients with PPMS, as demonstrated by stable mean EDSS, mean 9HPT and mean T25FW data, which encourage us to continue this on-going investigation."

Clinical • P2a data • CNS Disorders • Multiple Sclerosis • MRI

[VIRTUAL] Glatiramer acetate depot (extended-release) phase IIa study in patients with primary progressive multiple sclerosis: safety and efficacy snapshot (ECTRIMS 2021) - "These interim snapshot data suggest that GA Depot is possibly a safe and effective treatment for patients with PPMS, as demonstrated by stable mean EDSS, mean 9HPT and mean T25FW data, which encourage us to continue this on-going investigation."

Clinical • P2a data • CNS Disorders • Multiple Sclerosis • MRI

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS (clinicaltrials.gov) - P2a; N=25; Active, not recruiting; Sponsor: Mapi Pharma Ltd.; Trial completion date: Feb 2023 ➔ Nov 2024

Clinical • Trial completion date • CNS Disorders • Multiple Sclerosis • MRI

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS (clinicaltrials.gov) - P3; N=1000; Active, not recruiting; Sponsor: Mapi Pharma Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Multiple Sclerosis • MRI

[VIRTUAL] Glatiramer Acetate Depot (extended-release) phase IIa study in patients with Primary Progressive Multiple Sclerosis: safety and efficacy snapshot (AAN 2021) - "These data snapshot suggest that GA Depot is possibly a safe and effective treatment for patients with PPMS, as demonstrated by stable mean: EDSS, 9HPT and T25FW data, which encourage us to continue this investigation."

Clinical • P2a data • CNS Disorders • MRI