PARIS--(BUSINESS WIRE)--
Regulatory News:
Pharnext SA (Paris:ALPHA) (FR00111911287 - ALPHA), a French biopharmaceutical company developing an advanced portfolio of products in the field of neurodegenerative diseases, today announced that Phase 2 clinical trial data related to PXT864, a PLEODRUG® developed for the treatment of Alzheimer’s disease (AD), will be presented at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) conference, December 8-10, 2016 in San Diego (United States).
Details are as follows:
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Date |
Time |
Event |
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Friday
December 9 |
Poster Session 2, P2-12
Neurophysiological Effect of PXT864 in mild Alzheimer’s Disease Patients
Presenter: Karim Bennys, MD, Memory Research Resource Center for Alzheimer’s disease, University Hospital, Montpellier, France |
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Saturday
December 10 |
7:30 am |
Oral Communications Sessions, OC 54
36 Weeks of Treatment with PXT864 in Mild Alzheimer’s disease: Results from the PLEODIAL Extension Study
Presenter: René Goedkoop, MD, Chief Medical Officer, Pharnext, Issy-les-Moulineaux, France |
Safety and clinical efficacy of PXT864 were assessed in 45 treatment-naïve patients with mild AD in a multicenter, exploratory, single blind Phase 2 study (PLEODIAL-I). Three doses of PXT864 were administered for 4 weeks followed by 4 weeks of placebo and then a 4-week re-challenge with PXT864. Subjects were then invited to continue study treatment (same dose received in PLEODIAL-I) for a further 24 weeks in the PLEODIAL-II extension study. Patients were treated with PXT864 for 32 out of 36 weeks in the PLEODIAL-I and II studies, and were allowed to use donepezil 5 mg, if their condition warranted treatment with a symptomatic agent, during the last 12 weeks of the study.
PXT864 is a novel synergic fixed combination of baclofen and acamprosate given orally as a capsule twice a day. PXT864 was developed to restore the disrupted excitatory – inhibitory balance in the brain of patients suffering from neurodegenerative diseases (disrupted by toxic factors such as Aβ oligomeric peptides in Alzheimer’s disease). PXT864’s most advanced target indication is Alzheimer’s disease. Development in other neurodegenerative diseases including Parkinson’s disease and amyotrophic lateral sclerosis (ALS) are also planned.
About Alzheimer’s Disease
Alzheimer’s disease is an
irreversible, progressive neurodegenerative dementia. It is
characterized by neuronal death in brain structures implicated with
memory leading to cognitive deficits such as thinking, memory,
personality and behavior disorders. The disease typically develops and
worsens gradually over the course of several years and ultimately leads
to death. It affects around 25 million people worldwide. Unfortunately,
three out of four patients are diagnosed once the disease is at a severe
stage. Alzheimer's disease has no cure and current existing therapies
provide only short and modest symptomatic relief.
About Pharnext
Pharnext is an advanced clinical stage
biopharmaceutical company founded by renowned scientists and
entrepreneurs including Professor Daniel Cohen, a pioneer in modern
genomics. Pharnext focuses on neurodegenerative diseases and 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 is the pioneer of a new drug discovery
paradigm: PLEOTHERAPY®. The Company identifies and develops synergic
combinations of repositioned drugs at low dose. These PLEODRUG® offer
several key advantages: efficacy, safety, and intellectual property
including several composition of matter patents already granted. The
Company is supported by a world-class scientific team.
The company Pharnext is listed on Euronext Alternext Stock Exchange in Paris (ISIN code: FR00111911287).
For more information, visit www.pharnext.com
PLEODRUG® and PLEOTHERAPY® are registered trademarks by Pharnext.
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