Author Topic: (AAN) GA Depot (extended release) Phase IIa study in patients w/PPMS...  (Read 38 times)

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Offline agate

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Work is being done on a new version of glatiramer acetate (= Copaxone). This would be an intramuscular injection every 28 days and is apparently being called GA Depot.


Presented at the annual AAN conference Monday, April 4, 2022, by Mapi Pharma Ltd., makers of GA Depot--"Glatiramer acetate depot (extended release) Phase IIa study in patients with primary progressive multiple sclerosis:  Safety and efficacy snapshot":


https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-001329.html
MS Speaks--online for 16 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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From an e-mail from Mapi Pharma (September 21, 2022). Glatiramer acetate in an extended-release form, taken in a 40mg dose every 28 days via an intramuscular injection, may be available at some point. It has apparently done well in Phase III trials.



Quote
Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS)

The study evaluating a long-acting glatiramer acetate injection, GA Depot 40 mg once every four weeks, met the primary endpoint, significantly reducing the annualized relapse rate (ARR) by 30.1 percent compared to placebo


NESS ZIONA, Israel – Sep. 21, 2022 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, 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.



Top Line Results Highlights


The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066).

Analyses of various secondary efficacy endpoints and safety are ongoing. Following the initial 12-month placebo-controlled period, there is an ongoing one year open-label period extension of the trial. “We are pleased with the topline results of this study that show the potential of GA Depot 40 mg to offer patients an effective  treatment option using a more convenient dosing regimen which may potentially  improve compliance and adherence,” said Ehud Marom, CEO and Chairman, Mapi Pharma, “We believe the positive results set us on a path to commercialize GA Depot and we will work with our partner Viatris to make this potentially valuable new treatment option available to patients with RMS as early as possible. We look forward to providing the other secondary endpoints and overall safety and tolerability of the drug in the near future.”

“The positive top-line efficacy results from the GA Depot 40 mg Phase III trial are an exciting step forward in our long-standing commitment to supporting the needs of the multiple sclerosis community. GA Depot has the potential to be complementary to our comprehensive MS portfolio,” said Rajiv Malik, President, Viatris. “We look forward to our continued partnership with Mapi to deliver on our strategy of providing access to more complex and novel products and our mission to empower people worldwide to live healthier at every stage of life.”

“In an international Phase 3 double-blind, randomized, placebo-controlled trial, once monthly intramuscular injections of depot glatiramer acetate (GA Depot) demonstrated statistically significant efficacy, comparable to other available formulations of GA, that supports its potential designation as a first line therapy for relapsing forms of multiple sclerosis. The monthly administration of GA Depot should offer patients a much more preferable schedule than current regimens of GA, a long-standing pillar in the treatment of MS, and lead to improved patient satisfaction and medication adherence,” said the study’s Principal Investigator Aaron Miller, M.D., Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology, Icahn School of Medicine at Mount Sinai, New York.

Mapi Pharma and Viatris plan to work with regulatory authorities in the major markets to determine next steps.

About the Study

The multinational Phase III Study was designed to examine the safety, efficacy and tolerability of glatiramer acetate (GA) 40 mg intramuscular injection administered once every four weeks compared to placebo in a randomized double-blind placebo-controlled design in patients with relapsing forms of multiple sclerosis. The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase. A total of 1,016 subjects were randomized into two groups, receiving either 40mg of GA Depot or placebo, via intramuscular injection (IM), once every 4 weeks for a total of 13 doses.

About GA Depot

GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®), designed to be administered as an intramuscular injection once every four weeks. GA Depot is intended to be used for treatment of relapsing forms of Multiple Sclerosis (RMS). GA Depot is also currently being tested in Phase II for Primary Progressive Multiple Sclerosis (PPMS).
« Last Edit: September 22, 2022, 09:34:29 pm by agate »
MS Speaks--online for 16 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

Offline agate

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This upcoming Webinar may be more of a marketing occasion than anything else but more information about the intramuscular glatiramer injection every 4 weeks might be provided. So far it isn't clear to me whether this  intramuscular injection is meant to be self-administered, for instance.


This is an e-mail I received from Mapi Pharma:



Quote
Mapi Pharma to Host a Key Opinion Leader Webinar on Glatiramer Acetate Depot


GA Depot is a Potential Long Acting Injection Solution for Multiple Sclerosis Patients

Positive Results from Phase III GA Depot Study in Relapsing MS to be Reviewed


Webinar on Wednesday, October 19, 2022 @ 10:30 AM ET



NESS ZIONA, Israel – October 12, 2022 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, announced today it will host a key opinion leader (KOL) webinar on Glatiramer Acetate (GA) Depot, a potential long-acting injection solution for multiple sclerosis (MS) patients, on Wednesday, October 19, 2022 at 10:30 AM Eastern Time.


The webinar will feature KOL neurologists Aaron Miller, MD, from Mount Sinai, and Carlo Tornatore, MD, from Georgetown University Medical Center, who will discuss Mapi Pharma’s successful Phase III GA Depot clinical results and the contribution a monthly GA Depot will potentially have on improving standard of care to MS patients. Additionally, the KOLs will provide a comprehensive overview on the treatment landscape for Relapsing Forms of MS (RMS) and the unmet medical need for a long-acting monthly injection as compared to the approved daily or 3x/week GA injection, commercially available as Copaxone®, and its generic versions. Ehud Marom, Mapi Pharma’s Chairman and CEO will present the company’s promising long-acting Depot injectable pipeline with a focus on Semaglutide (SG) Depot for treating diabetes, weight control and potentially Parkinson’s Disease and other Depot products which will be registered via the FDA 505(b)(2) regulatory pathway or as ANDA that address billions of dollars markets.

A live Q&A session will follow the formal presentations. To register for the event, please click https://lifesci.rampard.com/WebcastingAppv5/Events/Registration/registration.jsp?step=1&Y2lk=MjA2Nw==&sessionid=F4348FA28C227B9E8E2667734DFC01C2


Positive top-line results from the GA Depot Phase III study were announced by Mapi Pharma in September 2022.
The study is designed to assess the efficacy, safety and tolerability of a once-monthly GA Depot 40 mg compared to placebo in relapsing forms of multiple sclerosis (RMS) patients.  The primary endpoint was met, showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066).  Mapi Pharma and its partner Viatris plan to work with regulatory authorities in the major markets to determine next steps.

Aaron Miller, MD, is the Medical Director of the Corinne Dickinson Center for Multiple Sclerosis and a Professor of Neurology at the Icahn School of Medicine at Mount Sinai. He also serves as Vice-Chair of Education in the Department of Neurology. For 23 years prior to becoming Medical Director, he headed the Division of Neurology at Maimonides Medical Center in Brooklyn, New York, where he also served as director of the Multiple Sclerosis Care Center. Dr. Miller served as Chief Medical Officer and Chairman of the Medical Advisory Board of the National Multiple Sclerosis Society (NMSS) from October 2009-2022 and is the immediate past president of the National Medical Advisory Board. He also served as the Chairman of the Clinical Advisory Committee of New York City Chapter of the NMSS from 1991-2004. He formerly served as the Chairman of the Professional Education Committee of the NMSS and is a past president of the Consortium on MS Centers. He was a member of the National Board of the NMSS from 2022-2017. Dr. Miller received the Hope Award from the National MS Society in 2021.
Dr. Miller was the first chairman of the multiple sclerosis section of the American Academy for Neurology and has participated in numerous clinical trials of new treatments for multiple sclerosis. Dr. Miller is also very active with the American Academy of Neurology for which he served as Editor of Continuum Audio from 2012-2021. He was secretary of the AAN Board (2013-2017) and also a member of the Board from 2009-2013. From 1997-2003, he served as Co-Chairman of the Education Committee and Chairman of the Annual Meeting Subcommittee.

CarloTornatore, MD, is Chairman and Neurologist-in-Chief of the Department of Neurology and Executive Director of the Multiple Sclerosis Patient-Centered Specialty Practice for Medstar at Geo
[size=78%]rgetown University Hospital. He is also Professor and Chairman of the Department of Neurology at Georgetown University Medical Center and Physician Executive Director for Neurology at Medstar Health.

Dr. Tornatore earned his Master’s degree in Physiology at Georgetown University and his medical degree at Georgetown University Medical School. He completed his internship at Providence Hospital and his Residency in neurology at Georgetown University Hospital. His fellowship was completed at the National Institute for Neurologic Disorders and Stroke at the National Institutes of Health (NIH) in the Laboratory of Molecular Medicine and Neuroscience in Bethesda, MD.

Dr. Tornatore is a member of the American Academy of Neurology and American Society for Neural Transplantation. His research interests include multiple sclerosis treatment, neuroimmunology, neuro-AIDS, and infectious diseases of the central nervous system, for which he has published a wide variety of articles and book chapters. In addition, he is a reviewer for several journals, including Annals of Neurology, Neurology and Medical Virology.

About the Phase III Study
[/size][size=78%]
The multinational Phase III Study was designed to examine the safety, efficacy and tolerability of a 40 mg GA intramuscular injection administered once every four weeks compared to placebo in a randomized double-blind placebo-controlled design in patients with RMS. The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase. A total of 1,016 subjects were randomized into two groups, receiving either 40 mg of GA Depot or placebo once every 4 weeks for a total of 13 doses.

About GA Depot

GA Depot is a long-acting injection version of the approved subcutaneous GA injection, commercially available as Copaxone®, designed to be administered as an intramuscular injection once every four weeks. GA Depot is intended to be used for treatment of RMS.[/size]
« Last Edit: October 12, 2022, 03:38:04 pm by agate »
MS Speaks--online for 16 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

 

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