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Prilenia
to Present Latest Research from its
Pridopidine
Programs for
Huntington Disease
and
ALS
at AAN 2024
2024-04-12
·
BioSpace
Pridopidine
is one of the most advanced investigational new drugs in HD and
ALS
and has shown consistent treatment benefits across independent measures important to patients and families -- Data to be presented at the American Academy of Neurology Annual Meeting 2024: HD: Oral presentation: The Impact of Antidopaminergic Medication on Longitudinal Clinical Progression in
Huntington Disease
-- Poster presentation: Analyses of the Phase 3 Trial of
Pridopidine
’s Outcome On Function in
Huntington Disease
(PROOF-HD) Demonstrate Efficacy in Participants Without Antidopaminergic Medication --
ALS
: Oral presentation:
Pridopidine
For the Treatment of
ALS
– Results From the Phase 2 HEALEY
ALS
Platform Trial NAARDEN, Netherlands & WALTHAM, Mass.--(BUSINESS WIRE)--
Prilenia Therapeutics B.V.
, a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of
neurodegenerative diseases
and
neurodevelopmental disorders
, today announced the presentation of the latest research from the
pridopidine
Huntington disease (HD)
and
amyotrophic lateral sclerosis
(
ALS
) programs at the American Academy of Neurology (AAN) Annual Congress, in Denver, Colorado, April 13-18. “
Pridopidine
is now in pre-registration phase in HD, with a first submission planned Mid 2024i, and is also set to commence a global Phase 3 study in
ALS
later this year. We are making significant strides forward and this is reflected by presentation of the data at one of the most important medical congresses in the field of Neurology,” said Jina Swarz, MD. Ph.D., the recently appointed Chief Medical Officer of
Prilenia
. “
Pridopidine
is one of the most advanced investigational new drugs in HD and
ALS
and has shown consistent treatment benefits across independent measures that are important to patients and families. The presented data advances knowledge in the field, providing important learnings for both clinical practice and for the design of our programs going forward. This advance is evident with novel findings from studies showing benefit with
pridopidine
in those with HD who are not taking anti-dopaminergic medication (ADMs) and a positive impact on speech and prolonged survival with
pridopidine
treatment in
ALS
.” Two oral and one poster presentations will be made at AAN 2024: Oral Presentations: Analyses of the Phase 3 Trial of
Pridopidine
’s Outcome On Function in
Huntington Disease
(PROOF-HD) Demonstrates Efficacy in Participants Without Antidopaminergic Medication Session name - S30:
Movement Disorders
: Clinical Trials in
Movement Disorders
; Program Number: S30.002. Presented by: Michael R Hayden, Founder and CEO,
Prilenia Therapeutics
; Wed, April 17, at 1:12 PM (MT)
Pridopidine
for the Treatment of
ALS
– Results from the Phase 2 HEALEY
ALS
Platform Trial Session name - S5:
ALS
and
CMT
: New Therapeutic Approaches; Program Number: S5.003. Presented by: Jeremy M Shefner, Professor, Department of Neurology,
Barrow Neurological Institute
; Sun, April 14, at 3:54 PM (MT) Poster Presentation: Analyses of the Phase 3 Trial of
Pridopidine
’s Outcome On Function in
Huntington Disease
(PROOF-HD) Demonstrate Efficacy in Participants Without Antidopaminergic Medication Session name - P6:
Movement Disorders
: Huntington's and Other Choreas 1; Program Number: P6.003. Presented by: Randal Hand, Director of Neuroscience,
Prilenia Therapeutics
; Tue, April 16, from 8:00-9:00a (MT) About
Pridopidine
Pridopidine
(45 mg twice daily) is an oral, highly selective and potent investigational
S1R agonist
S1R
agonist that has exhibited a safety and tolerability pro to placebo in clinical studies to date. The safety dataset includes over 1,700 patients who have been on
pridopidine
for up to seven years. The
S1R
protein is highly expressed in the brain and spinal cord, where it regulates several key processes that are commonly impaired in various
neurodegenerative diseases
. Activation of the
S1R
by
pridopidine
stimulates multiple cellular protective pathways including enhancing autophagy, axonal transport, mitochondrial energy production and respiration, and restores calcium homeostasis. These effects are essential to neuronal function and survival, and lead to neuroprotective effects.
Prilenia
holds Orphan Drug designation for
pridopidine
in HD and
ALS
in the U.S. and EU. In addition,
pridopidine
has received Fast Track designation by the
U.S. Food and Drug Administration (FDA)
for the treatment of HD. About
Prilenia
Prilenia
is a clinical stage biotechnology company founded in 2018 focused on the urgent mission to develop novel therapeutics to slow the progression of
neurodegenerative diseases
and
neurodevelopmental disorders
. The initial focus of the company has been on HD and
ALS
.
Prilenia
is backed by a group of respected investors including: Forbion,
Morningside
,
Sands Capital
, SV Health Investors, Sectoral Asset Management,
Talisman
,
Amplitude Ventures
and the ALS Investment Fund. The Company is based in the Netherlands, Israel and Massachusetts in the U.S. For more information, visit and follow us on LinkedIn and X (formerly known as Twitter). ©2024
Prilenia Therapeutics B.V.
For a copy of this release, visit
Prilenia
’s website at . i First submission planned for the EU, with other regulatory submissions to follow
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