Date: 2016-04-04
Type of
information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Oryzon Genomics (Spain)
Product: ORY-2001
Action
mechanism: enzyme inhibitor/LSD1-MAOB inhibitor. ORY-2001 is a highly selective dual LSD1-MAOB inhibitor. LSD1 is an epigenetic modulator, which regulates histone methylation. Epigenetic approaches to modify the progression of various neurodegenerative diseases focus on producing changes in patterns of gene expression in neurons and also in glia cells. ORY-2001 has a good safety profile and therapeutic index in preclinical trials. In nontransgenic AD mouse models, long-term treatments with the drug demonstrated a marked cognitive improvement. and are of interest for the pharmaceutical industry. Oryzon is further exploring the potential of ORY-2001 in other neurodegenerative diseases, such as Huntington’s disease, Parkinson’s disease and other dementias.
Disease: Alzheimer's disease
Therapeutic
area: Neurodegenerative diseases
Country: Spain
Trial
details:
Latest
news:
- • On April 4, 2016, Oryzon Genomics announced that the first subject has been dosed in a Phase I, randomized, double-blind, placebo-controlled single and multiple ascending dose program study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral LSD1- MAOB dual selective inhibitor ORY-2001 in healthy subjects. The Phase I study is being conducted in Spain, pursuant to a Clinical Trial Application (CTA). With a successful study outcome, ORY-2001 is expected to proceed to a Phase II study in Alzheimer’s disease patients in 1H 2017.
• On January 29, 2016, Oryzon Genomics announced that the Company received approval of its Clinical Trial Application from the Spanish Drug Agency (AEMPS) to initiate a Phase I clinical trial for ORY-2001 for the treatment of Alzheimer's disease. The Phase I trial will be conducted at a reputed Phase I clinical trial unit of a university hospital in Barcelona, Spain. The trial will evaluate the safety, tolerability and pharmacokinetics of ORY-2001 in healthy subjects as well as the elderly population. In addition to the treatment of Alzheimer's disease, ORY-2001 is in preclinical development to assess the potential effectiveness in other neurodegenerative diseases.
- • On December 16, 2015, Oryzon Genomics announced that a Clinical Trial Application (CTA) has been filed with the Spanish Drug Agency (AEMPS) to conduct a Phase I clinical study with healthy volunteers as a first step to determine the potential of ORY-2001 for the treatment of Alzheimer’s disease (AD). The design of the Phase I clinical trial is a single center, double blind, parallel, ascending single and multiple dose program. The study will assess the safety, tolerability and pharmacokinetics of single and multiple oral doses of ORY-2001 in healthy male and female subjects and also in the elderly population. Hospital de Sant Pau in Barcelona, Spain will be the site center. ORY-2001 is the second epigenetic drug that Oryzon is advancing into clinical trials.
Is
general: Yes
