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The Spanish Agency of Medicines and Medical Devices (AEMPS) has given the green light to begin a phase I clinical trial on molecule ORY-2001, developed entirely by Oryzon Genomics, to assess its potential to treat Alzheimer.

Oryzon Chief Medical Officer Dr. César Molinero explains that what sets this drug apart from the rest is that ORY-2001 doesn’t focus on alleviating the symptoms of the disease; it curbs its progress. The trial, which will be conducted at Hospital de la Santa Creu i Sant Pau Barcelona, will evaluate the safety, tolerability and pharmacokinetics of ORY-2001 in healthy subjects as well as the elderly population.

Molinero explains that the molecule slows or reverses cognitive deterioration in Alzheimer animal models, as demonstrated in preclinical studies of an oral compound that also showed the molecule to have a good safety profile. ORY-2001 is a dual LSD1-MAOB inhibitor, which is an epigenetic modulator that regulates histone methylation. In fact, epigenetic approaches to modifying several neurodegenerative diseases focus on changing patterns of gene expression in neurons and brain support cells, the glia.

In addition to the clinical trial, Oryzon Genomics will continue preclinical research into the effectiveness of the compound on other neurodegenerative diseases. César Molinero points to Parkinson and Huntington as two possible targets.

With this latest AEMPS approval, the company has now brought two molecules to the clinical phase. The first was ORY-1001 to treat Acute Myeloid Leukemia, an inhibitor now showing positive results in phase I/II A that has been licensed to Swiss multinational corporation Roche since 2014. César Molinero confirmed with Biocat that the company does not yet know when or who the ORY-2001 molecule will be licensed to.


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