AlzProtect : The American Food and Drug Administration (FDA) Has Granted AZP2006 the Orphan Drug Designation for the Treatment of Progressive Supranuclear Palsy (PSP)
The drug candidate AZP2006 has an original mechanism of action and aims to treat several neurodegenerative pathologies for which there is no treatment: Tauopathies including Alzheimer’s disease and Progressive Supranuclear Palsy (PSP).
Lille, France 04 May, 2017 – AlzProtect, a biopharmaceutical company committed to the development of drugs for the treatment of neurodegenerative diseases, today announces the decision of the US FDA to grant orphan drug status to AZP2006 for the treatment of Progressive Supranuclear Palsy (PSP).
This orphan drug status provides a number of commercial benefits for AlzProtect, including a seven-year period of exclusive drug marketing, exemption of certain fees from the Food and Drug Administration and tax credits for clinical trials.
Progressive Supranuclear Palsy (PSP) is a rare neurodegenerative disease. Like Alzheimer’s disease, it is characterized by the accumulation of a protein in the brain called tau as a toxic modified form that, over time, gradually damages the neurons. It reaches 25,000 people in the United States (and 30,000 in Europe). There is no treatment of PSP while it dramatically reduces life expectancy.
FDA experts validated the robustness and relevance of cellular and animal models with PSP pathophysiology and thus confirmed that the intention to treat PSP with AZP2006 was considered justified on the basis of these preclinical data. This drug candidate is currently at the end of the clinical phase 1.
“This is a very important milestone for the development of AZP2006. We now have a visibility in the United States a country in which we want to grow” said Dr. Philippe Verwaerde, scientific director and president of AlzProtect.
About the “orphan drug” status
The FDA may grant “orphan drug” status to facilitate the development of drugs that target pathologies that affect fewer than 200,000 people in the United States and provide a significant therapeutic advantage over those already licensed in the marketplace.
About Progressive Supranuclear Palsy
The PSP, Progressive Supranuclear Palsy, is also called the Steele, Richardson and Olszewski disease named after the three neurologists who identified it and described it in 1964. PSP is a tauopathy with predominant accumulation of tau isoforms with four repeating units (4R). It is characterized by neurofibrillary degeneration and neural loss in the brain stem, central gray nuclei, motor and associative frontal cortex. The disease causes brain stem lesions, thus gradually affecting balance, sight, mobility, swallowing and speech. Initial disorders are also present in other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s.
Founded in 2007, AlzProtect is a Lille company resulting from the work of Dr. André Delacourte, one of the pioneers of research on Alzheimer’s disease and Professor Patricia Melnyk, expert in medicinal chemistry, in collaboration with Lille University 2 And the INSERM.
Located on the Eurasanté Park, AlzProtect is committed to the development of innovative therapeutic solutions in the field of neurodegenerative diseases. Its most advanced candidate, AZP2006, has obtained several proofs of preclinical concept in the treatment of Progressive Supranuclear Palsy and Alzheimer’s disease.
The company employs 10 people and benefits from the support of Bpifrance (formerly OSEO), the ANR (National Research Agency) and Eurasanté. AlzProtect intends to develop and sublicense its molecules following proof of concept in man.
President and CSO
Dr Philippe Verwaerde
Email: [email protected]
Tel: +33 (0)3 28 55 50 51