Dr Gilbert Wagener brings to Pharnext 30 years of experience in medical affairs and R&D in various therapeutic areas, including neurological and/or rare diseases, and on products at various stages of clinical development from Phase I to pivotal III. Dr Gilbert Wagener's profile is a perfect fit with Pharnext's needs to complete the clinical development of PXT3003 in Charcot-Marie-Tooth type 1A disease ('CMT1A') and support its potential commercialization.
PARIS, France, June 15, 2023, 08:30 am CET - Pharnext SA (FR001400GUN7 - ALPHA) (the "Company"), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces the appointment of Dr Gilbert Wagener as Chief Medical Officer ('CMO').
Dr Gilbert Wagener is an expert in late-stage drug development with three decades experience leading clinical research in cardiovascular, immune-mediated and CNS indications including orphan diseases. He joins Pharnext from Ixaka where he held the position of CMO and Head of R&D, and oversaw the Phase III development of cell therapy in chronic limb-threatening ischemia. Prior to this, Dr Wagener was a Senior Partner at TranScrip Partners LLP where he was the strategic lead on several drug programs. This involved work on assets at various stages in the drug development life cycle and leading on due diligence, development strategy, and Phase I-III clinical studies. He previously served at Genzyme Europe and Bayer Healthcare AG with a particular interest in clinical trial design and adoption of new products into medical practice.
Gilbert studied and practiced human medicine at Marburg University Hospitals, Germany, with an MD thesis in pharmacology and clinical practice in Neurophysiology and clinical Neurology. He also earned an MBA in Pharmaceutical Medicine from the University of Basel, Switzerland and a PhD in Epidemiology/Public Health at the Erasmus University, Rotterdam, The Netherlands. Gilbert is a fellow of the European Society of Hypertension and a member of the European Society of Cardiology cardiovascular pharmacology and drug therapy working group; BIA Cell Therapy and Regenerative Medicine Advisory Committee; German Society of Pharmacology and Toxicology; and the German Society of Physiology.
At Pharnext, Dr Wagener will be responsible for driving the company's clinical development of PXT3003, Pharnext's lead candidate designed to treat CMT1A, a rare progressive, inherited neurological disorder that affects the peripheral nerves with currently no existing approved therapies.
At Pharnext, Dr Gilbert Wagener will be responsible for driving and completing the clinical development of PXT3003 (the PREMIER trial), Pharnext's lead drug candidate designed to treat CMT1A, a rare progressive, inherited neurological disorder that affects the peripheral nerves with currently no existing approved therapies. If the PREMIER trial is positive, Dr Wagener will also be involved in discussions with regulatory agencies (FDA and EMA) about filing of marketing authorization applications which could lead to PXT3003 being made available to patients with CMT1A. Dr Wagener might work on other projects of drug candidate development in other neurological diseases, depending on priorities defined by Pharnext.
Hugo Brugière, Pharnext management representative, commented: "I am delighted to welcome Gilbert to the team and look forward to working with him. He brings deep invaluable medical and scientific experience and expertise as we continue to progress our Phase III trial for PXT3003. Gilbert will play a crucial role in steering this development program through the coming critical stage and beyond, such as future discussions with regulatory authorities. His appointment as CMO comes at a pivotal time for the company as Dr. Burkhard Blank has decided to depart for a new external opportunity. On behalf of the team, I want to thank Burkhard for his commitment and engagement to the development of PXT3003 and wish him all the best in his new role."
On his appointment as Chief Medical Officer, Dr. Gilbert Wagener commented: "I'm pleased to be joining Pharnext's team and am excited by the prospect of supporting this important medicine through late-stage clinical development and potential commercialization. Pharnext is seeking to address a major unmet medical need by securing an approval for the first medical treatment for CMT1A. I look forward to working with the team to help achieve this and transform the quality of lives of patients with CMT1A, who endure symptoms that progress throughout life."
About Pharnext
Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases currently without satisfactory therapeutic solutions. Pharnext has a first-in-class drug candidate, PXT3003, in development for Charcot-Marie-Tooth disease type 1A (CMT1A), a rare, debilitating, inherited peripheral neuropathy. PXT3003 benefits from orphan drug status in Europe and the United States. In 2018, PXT3003 completed a Phase III clinical trial, the PLEO-CMT trial, with encouraging topline results. This trial was followed by an open-label extension study, the PLEO-CMT-FU trial, with 120 patients continuing treatment with PXT3003. Long-term data suggest a sustained benefit, safety, and efficacy, after 5 years of total trial time. An international pivotal Phase III study of PXT3003, the PREMIER trial, is currently ongoing with 387 CMT1A patients enrolled. PREMIER topline results are expected in Q4 2023. PXT3003 originated from the Pleotherapy R&D approach. Pharnext draws the attention of investors to the financial and other risk factors detailed in its financial reports. More information can be found at www.pharnext.com.
Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR001400GUN7).
Contacts
| Relations Presse Financière ACTUS finance & communication Déborah Schwartz dschwartz@actus.fr +33 (0)1 53 67 36 35 | Relation Investisseurs ACTUS finance & communication Jérôme Fabreguettes Leib pharnext@actus.fr +33 (0)1 53 67 36 78 |
- SECURITY MASTER Key: xp1waMhplpyax25wY5uab5Rsa29mkmTImGSbk2NxYp2bb2pmypuWapmYZnFhmWlp
- Check this key: https://www.security-master-key.com.
https://www.actusnews.com/documents_communiques/ACTUS-0-80443-2023.06.15_cmo-nomination_en.pdf
© Copyright Actusnews Wire
Receive by email the next press releases of the company by registering on www.actusnews.com, it's free
