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DIR Return to: COPAXONE, GLATOPA (glatiramer acetate)
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#Post#: 3603--------------------------------------------------
GA Depot--extended release glatiramer, 40 mg every 28 days with
intramuscular injection
DIR By: agate
Date: April 5, 2022, 1:00 am
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From an e-mail from Mapi Pharma. 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).
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