Pharnext Presents Positive Exploratory Phase 2 Data From PXT864 at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, United States
Pharnext SA (Paris:ALPHA) (FR00111911287 - ALPHA), a French biopharmaceutical company developing an advanced portfolio of products in the field of neurodegenerative diseases, presented positive exploratory Phase 2 data for PXT864, a PLEODRUG© being developed for the treatment of Alzheimer’s disease (AD), at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) conference, on December 8-10, 2016 in San Diego (United States).
Data collected during the PLEODIAL© clinical trial suggests that:
- PXT864 is well tolerated and safe for use in patients with AD: excellent compliance rate above 90%, without serious or unexpected Adverse Events (AE) and no AE led to medical intervention or study treatment discontinuation.
- PXT864 may slow the progression of cognitive disability in patients with mild AD. The primary endpoint of the study – AD Assessment Scale Cognitive Subscale test (ADAS-Cog-11) – appeared to decline less in the pooled PXT864 dose 1 and 2 groups as compared to historical placebo for mild to moderate patients with AD at week 36.
- PXT864 may be used concomitantly with low-dose donepezil treatment (5 mg daily): no new safety concern arose when donepezil was administered concomitantly with PXT864 at week 24 and onwards. In addition, concomitant PXT864-donepezil administration pointed towards an improvement or at least a stabilization of ADAS-Cog-11 score at week 36.
These findings show promising efficacy of PXT864 to be further explored in future studies, such as an international multicenter adaptive-design Phase 2 study.
“We believe that these findings bring new evidence of PXT864 safety and efficacy in patients suffering from mild stages of Alzheimer’s disease and this clinical trial has the potential to be a key turning point in the effort to finally provide an efficacious treatment for these patients,” said Daniel Cohen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Pharnext. “These data also further validate our PLEOTHERAPY © research and development approach and we hope to provide novel treatments for many diseases via such synergic drug combinations.”
René Goedkoop, M.D., Chief Medical Officer of Pharnext added, “The data presented provide encouraging evidence for PXT864 as an entirely new approach in the treatment of Alzheimer’s disease. Today there are no treatments capable of altering the progressive course of this terrible disease. We look forward to the continuation of PXT864 clinical development and hope that we can bring an efficacious treatment to people suffering from Alzheimer’s disease and to improve their quality of life.”
PXT864 is a novel rational-design synergic fixed combination of baclofen and acamprosate given orally as a capsule twice a day. PXT864 is thought 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. Clinical development of PXT864 in other neurodegenerative diseases including Parkinson’s disease and amyotrophic lateral sclerosis (ALS) is 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 only 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.
The PLEODIAL© trial was an exploratory multicenter single blind Phase 2 study that evaluated 3 doses of PXT864 in 45 patients with mild Alzheimer’s disease who were naïve to anti-dementia treatment: the first two doses were based on the same ratio of baclofen / acamprosate [dose 1 and 2] and the third dose used another ratio [dose 3]. The main objectives were to assess safety, compliance and preliminary efficacy on cognitive and behavioral impairment. The study was designed over a period of 36 weeks: “PLEODIAL-I” for the first 12 weeks followed by “PLEODIAL-II” for the remaining 24 weeks. During PLEODIAL-I, patients received PXT864 during the first 4 weeks (“challenge”) followed by 4 weeks of placebo (“dechallenge”) and then 4 weeks of PXT864 (“re-challenge”). During PLEODIAL-II, patients were invited to continue on PXT864 with the dose they had received during PLEODIAL-I. During the last 12 weeks of the study, physicians were authorized to co-administrate donepezil 5 mg with PXT864. In total, patients were treated with PXT864 for 32 out of 36 weeks in the PLEODIAL-I and II studies. This clinical trial was conducted in 7 French memory centers (CMRR: Centre Mémoire de Ressource et de Recherche) from February 2013 (first patient in) to December 2015 (last patient out).
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
Pierre Schwich, +33 (0)1 41 09 22 30
Chief Financial Officer
Julie Coulot, +33 (0)1 44 71 20 40
Media Relations (Europe)
+33 (0)1 44 54 36 64
Media Relations (US)
Tony Russo, Ph.D.
Matt Middleman, M.D.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Capgemini Gives Technology a Human Touch, with a New Brand Identity Designed by BrandPie.18.10.2017 08:30 | Pressemelding
Capgemini, one of the world’s leading global technology and consulting firms, yesterday launched its new brand identity, designed by strategic brand consultancy BrandPie. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018005101/en/ Capgemini's new brand identity, designed by BrandPie BrandPie worked in close collaboration with Capgemini’s leadership team over 15 months to create a dynamic digital-first brand identity and wordmark, inspired by the handwriting of Serge Kampf, Capgemini’s founder. Meanwhile, its iconic spade emblem has been redrawn to reflect the world the business is now in. Coinciding with the Group’s 50th anniversary, this is the first overhaul of Capgemini’s brand identity since 2004, and has been crafted to ensure that it remains ahead of its peers in its
GSMA and AIC Encourage Greater Engagement among RCEP Countries to Enable a Truly Pan-Asian Digital Economy18.10.2017 07:00 | Pressemelding
The GSMA and the Asia Internet Coalition (AIC) today urged the participating countries of the Regional Comprehensive Economic Partnership (RCEP) for greater commitment and engagement. As representatives of leading companies that operate in the region and promote the digital economy, the GSMA and AIC believe that the RCEP can play a critical role in enabling positive policy development in the digital economy and reducing or removing barriers and restrictions that suppress digital trade and investments in the Asia Pacific region. “The RCEP will play an increasingly important role in the region’s digital future, as it involves all of the largest Asian economies, including both ASEAN and non-ASEAN nations,” said Alasdair Grant, head of Asia Pacific for the GSMA. “This is even more critical in light of the stalled talks on the Trans-Pacific Partnership, as well as the growing need for innov
Utimaco Launches PaymentServer 3.00.0 To Help Payment Industry Reach PCI Compliance18.10.2017 06:11 | Pressemelding
As the Payment Card Industry (PCI) continues to heat up, Utimaco is providing enterprises in the banking and financial services sector with the opportunity to achieve PCI compliance through its latest launch, PaymentServer 3.00.0. The new PaymentServer is a PCI Standards Security Council accredited PCI PIN Transaction Security Hardware Security Module Version 2 (PCI PTS HSM V2) solution that comes with a complete offering, including the HSM, a Software Development Kit, and additional services such as integration support, certification assistance and tiered maintenance. All of this allows Utimaco partners to focus on business innovation with the assurance that their work remains or regains PCI compliance. Using Utimaco’s flexible software development kit, companies can reach full PCI compliance for a solution or environment based on the standard product offering from PaymentServer or vi
Norsk Titanium Dedicates Plattsburgh Machines at Ceremony with New York Governor18.10.2017 06:00 | Pressemelding
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, held a dedication ceremony yesterday of its Plattsburgh Development and Qualification Center (PDQC) in Plattsburgh, New York. This facility, which currently houses nine of Norsk’s proprietary Rapid Plasma DepositionTM (RPD) titanium printing machines, signifies the partnership between Norsk and the state of New York. The site will produce aerospace components for Boeing and other aerospace producers. State and local officials, including New York Governor Andrew Cuomo, Howard Zemsky of Empire State Development, Michael Cashman of the Town of Plattsburgh, the City of Plattsburgh Mayor Colin Reed and Garry Douglas of the North Country Chamber of Commerce participated in the ceremony. "Norsk could have chosen anywhere in the nation to set up their
The Body Shop Switzerland Transforms the Shopping Experience with Axway18.10.2017 06:00 | Pressemelding
The Body Shop, an international beauty business, is leveraging Axway (Paris:AXW) (Euronext: AXW.PA), a catalyst for digital transformation, to improve the customer experience at retail stores throughout Switzerland. With Axway Appcelerator, The Body Shop has been able to rethink its customer loyalty program, integrate massive amounts of data, and successfully implement an innovative new mobile application to increase in-store purchases. The new Axway-powered Love Your Body Club mobile app has enabled The Body Shop to deliver personalized and contextualized experience to more than 90,000 customers in Switzerland. Formed in 1976, The Body Shop is an international, ethical beauty business that sells more than 900 different beauty products in 2,600 stores worldwide and online. To build on its successful business in Switzerland and enhance the experience it offers to customers in the
SailPoint Propels the Identity-Aware Enterprise with New Version of IdentityIQTM18.10.2017 05:01 | Pressemelding
From Navigate ’17, SailPoint, the leader in enterprise identity management, today announced several enhancements to its open identity platform, designed to further enable identity to be woven throughout the IT operations and security fabric of global organizations. Now, critical identity governance processes, such as separation-of-duty policies and access request approvals, can be leveraged as a shared service within solutions that help support an identity-aware ecosystem. This accelerates the time it takes to get visibility into and control over crucial resources, while also enabling a unified approach to identity governance that shares identity context across all IT and security investments. With an identity-aware IT ecosystem, customers are better prepared to mitigate, identify and contain data breaches. The latest iteration of SailPoint’s IdentityIQ, which i
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom