ORYZON announces First Patients In ETHERAL: a Phase IIa clinical trial in Alzheimer’s Disease with ORY-2001

The trial was approved in Spain in April and in France last week

First three patients included in Spain last week

This is the second Phase IIa study in a CNS indication with the drug

MADRID, Spain and CAMBRIDGE, MA, USA I May 14, 2018 I Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today the inclusion last week of the First Patients in its Phase IIa clinical trial with ORY-2001 in mild and moderate Alzheimer’s disease patients.

The Spanish Medicines Agency (AEMPS) approved the trial in Spain at the beginning of April, and the company received the approval from the Agence Nacional du Securité du Medicament et des Produits de Santé (ANSM), the French regulatory agency, and the Ethics Committee to start the trial in France just a few days ago. The first three patients in this clinical trial have now been included in two hospitals from Barcelona. The study will be conducted in different European hospitals across Spain, France, and also in UK once the corresponding approvals from the British regulatory authorities are obtained.

The study, named ETHERAL (Epigenetic THERapy in ALzheimer’s Disease), is designed as a randomised, double-blind, placebo-controlled, 3-arm, 26 weeks parallel-group study to evaluate the safety and tolerability of ORY2001 in patients with mild and moderate Alzheimer’s disease. The study will involve 90 patients and incorporates measurements in the different domains of the disease as secondary endpoints, including memory and behavior alterations. It will also monitor the variations of diverse, yet significant CSF biomarkers. The company is aiming to launch a twin study in the US soon with a, yet to be determined, number of additional patients.

ORY-2001 is an oral and brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels, reduces cognitive impairment, memory loss and neuroinflammation, and at the same time has neuroprotective effects. The company has recently reported in several scientific conferences that ORY-2001 exerts a holistic action on different types of alterations also seen in patients with AD and other neurodegenerative disorders. ORY-2001 may act as a disease modifying drug. In AD patients and other neurodegenerative disorders, cognitive deterioration is often accompanied by episodes of agitation, aggression, psychosis, apathy and depression. In preclinical studies, ORY-2001 not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease, to normal levels and also reduces social avoidance in rat models maintained in isolation. In addition, ORY-2001 exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). The company has already started a Phase IIa clinical study with ORY-2001 in patients with MS.

Roger Bullock, Oryzon’s Chief Medical Officer, commented, "The commencement of ETHERAL, the first Phase IIa clinical trial for an epigenetic agent in AD, represents an important milestone for both the company and the Alzheimer’s community. Preclinical studies demonstrate the potential of ORY-2001 in treating cognitive defects and neuroinflammation across CNS disorders by increasing the plasticity and functionality of neurons. This is the first step in exploring this novel approach for AD and we have chosen to study this initially in the mild to moderate population where we believe there is still physiological room to make a significant therapeutic intervention with this approach and which offers new opportunity to a patient population that has seen less options within the current research approaches.”

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. The company has offices in Spain and USA. For more information, visit www.oryzon.com.

SOURCE: Oryzon

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