European Medicines Agency Agrees with Pharnext’s Pediatric Investigation Plan for PXT3003
10 Juli 2018 - 7:30AM
Business Wire
This agreement paves the way for the submission
of a marketing authorization application in Europe
Regulatory News:
Pharnext SA (Paris:ALPHA) (FR0011191287 – ALPHA),
a biopharmaceutical company pioneering a new approach to the
development of innovative drug combinations based on big genomic
data and artificial intelligence, today announced that the European
Medicines Agency (EMA) has agreed with its pediatric investigation
plan (PIP) for PXT3003 in Charcot-Marie-Tooth disease type 1A
(CMT1A).
“The EMA agreement with our PIP represents a significant step
forward in our efforts to bring PXT3003 to patients in Europe,”
said Prof. Daniel Cohen, M.D., Ph.D., Co-Founder and Chief
Executive Officer of Pharnext. “Given that much of the
progression of CMT1A occurs in the first two decades of patients’
lives, we believe that by intervening in childhood, we can have a
greater impact on patients’ disease trajectory. In our Phase 2
study, PXT3003 was observed to stablilize and slow the progression
of CMT1A, and also demonstrated clinical improvement in patients.
We are dedicated to providing the estimated 14,000 children in
Europe living with CMT1A a safe therapeutic option that may offer
significant long-term relief.”
As part of the regulatory process for registering new medicines
with the EMA, pharmaceutical companies are required to provide a
PIP that outlines the clinical development strategy for studying
the investigational product in children. EMA agreement with the PIP
is required before a company can file a marketing authorization
application (MAA) for any new medicinal product in Europe.
PXT3003 is being evaluated in an international pivotal Phase 3
clinical trial in adults with CMT1A, with top-line results expected
by October 2018. The clinical study investigating the safety and
efficacy of PXT3003 for CMT1A in children will be conducted in
Europe, Canada and the United States.
About Pharnext
Pharnext is an advanced clinical-stage biopharmaceutical company
developing novel therapeutics for orphan and common
neurodegenerative diseases that currently lack curative and/or
disease-modifying treatments. Pharnext has two lead products in
clinical development. PXT3003 is currently in an international
Phase 3 trial for the treatment of Charcot-Marie-Tooth disease type
1A and benefits from orphan drug status in Europe and the United
States. PXT864 has generated positive Phase 2 results in
Alzheimer’s disease. Pharnext has developed a new drug discovery
paradigm based on big genomic data and artificial intelligence:
PLEOTHERAPY™. The Company identifies and develops synergic
combinations of drugs called PLEODRUG™ offering several key
advantages: efficacy, safety and robust intellectual property. The
Company was founded by renowned scientists and entrepreneurs
including Professor Daniel Cohen, a pioneer in modern genomics and
is supported by a world-class scientific team.
Pharnext is listed on Euronext Growth Stock Exchange in Paris
(ISIN code: FR0011191287).
For more information, visit http://www.pharnext.com/
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version on businesswire.com: https://www.businesswire.com/news/home/20180709005744/en/
PharnextRené GoedKoop, +33 (0)1 41 09 22 30Chief Medical
Officermedical@pharnext.comorFinancial Communication
(France)ActifinStéphane Ruiz, +33 (0)1 56 88 11
15sruiz@actifin.frorInvestor Relations (U.S.)Stern Investor
Relations, Inc.Matthew Shinseki,
+1-212-362-1200matthew@sternir.comorInvestor Relations
(Europe)MC Services AGAnne Hennecke, +49 211 529252
22anne.hennecke@mc-services.euorMedia Relations
(Europe)Ulysse CommunicationBruno Arabian, +33 (0)1 81 70 96
30barabian@ulysse-communication.comorMedia
Relations (U.S.)RooneyPartnersKate L. Barrette,
+1-212-223-0561kbarrette@rooneyco.com
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