ORFONEURO
OrfoNeuro ApS is a Danish biopharmaceutical company founded in 2016
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OrfoNeuro
Overview
OrfoNeuro ApS is a Danish biopharmaceutical company founded in 2016 and focused on the development and commercialization of novel enzyme replacement therapies for the treatment of life-threatening Orphan Diseases.
OrfoNeuro collaborates with Prof. Paul Saftig, the Institute of Biochemistry, University of Kiel, Germany, who is a KOL in lysosomal diseases and previously the coordinator of the EU Framework projects, HUEMAN and ALPHAMAN, which both focused on alpha-Mannosidosis and in which Zymenex was the industrial partner.
The Opportunity
OrfoNeuro’s initial product focuses on treatment of enzyme-related neuronal diseases: Neuronal Ceroid Lipofuscinosis (NCL), a lysosomal storage disorder.
NCLs are a group of 14 related diseases, which can be caused by a deficiency of enzyme in the lysosomes, which causes a blockage of autophagic flow. These diseases could be treated for the blockage by Cathepsin-D.
NCL has a prevalence of 1 in 100.000. Patients usually appear normal at birth, but early visual loss leading to complete retinal blindness can be the first indicator of the disease.
The symptoms are characterized by a progressive, permanent loss of motor and psychological ability with seizures and a severe intracellular accumulation of lipofuscins leading to a vegetative state.
Management and Previous Achievements
Jens Fogh, DVM, Founder & Chief Executive Officer.
Jens Fogh is the founder and CEO of OrfoNeuro ApS. Jens has been involved in the Biopharmaceutical Industry since 1986.
He has previously been a Director at Novo Nordisk working in R&D, Quality Assurance, Regulatory and Marketing in Japan and the US. Jens has been an active member of EFPIA and co-author on ICH Guidelines.
In 1998 he co-founded Zymenex A/S and was the CEO until 2015. During these years he was instrumental in bringing two key Orphan Drug products forward. Metazym for the treatment of the lysosomal disease Metachromatic Leukodystrophy was developed by Zymenex from an idea through Phase 2 and was sold to Shire in 2008 and Lamzede, developed by Zymenex from an idea through Phase 3, was bought by Chiesi in 2013 and has in 2018 received market approval in the EU as a therapy for the lysosomal disease alpha-Mannosidosis.
Jens received his DVM degree from the Royal Veterinary School in Copenhagen, Denmark and is the author and co-author of more than 50 scientific publications and patents.
Cathepsin-D for Neuronal Ceroid Lipofuscinosis (NCL)
OrfoNeuro’s lead product human Cathepsin-D (pro-Cathepsin-D, rhproCTSD) is an enzyme replacement therapy currently in the development phase for the treatment of NCLs.
Studies together with U. of Kiel have demonstrated that the recombinant pro-Cathepsin-D is taken up and successfully delivered to lysosomes in vitro in cells and in vivo in murine disease models.
Dosing Cathepsin-D knockout mice with Cathepsin-D leads to an uptake and a correction of many of the pathological manifestations of NCL such as autophagic flux.
