During the first half of 2021, Oryzon Genomics has obtained the support of commercial banks through the formalization of long-term loans worth 4.3 million euros at an average interest rate of 2%,
As of June 30, 2021, Oryzon maintains a significantly robust financial position that allows it to continue with the development of its R&D activities and the development of its Phase IIb clinical studies.
The negative result of 1.0 million, improves by 25% despite the investment effort of 1.2 million euros in non-capitalized activities without income recognition in early project research, and in development activities to contribute to the fight against COVID-19 in the ESCAPE clinical trial, when the Company obtained income from tax deductions for R&D for Cash back of 2.5 million euros.
The balance sheet as of June 30, 2021 shows a relevant robustness with a net worth of 74.9 million euros and available cash and financial investments of 33.7 million euros.
The company has continued to advance in this first quarter in the clinical development of its iadademstat oncology and vafidemstat neurology programs.
Iadademstat in oncology:
The Phase II ALICE trial, investigating the use of iadademstat in combination with azacitidine in acute myeloid leukemia (AML), continues recruitment. The preliminary results corresponding to the 30 months of the study, presented at the EHA2021 congress, show robust signs of clinical efficacy, with ORR of 83%, of which 67% are CR / CRi. Responses are early and long-lasting, with five patients with remissions greater than one year and the longest remission of 858 days, still ongoing. The combination of iadademstat and azacitidine continues to show a good safety profile. The company plans to present a new clinical update on ALICE at the ASH-2021 congress.
The US Drug Regulatory Agency (FDA) has granted orphan drug designation to iadademstat for the treatment of AML. The drug now has orphan drug designation in both the United States and the EU.
The company is preparing new combination trials in AML and solid tumors. The company believes there is potential for accelerated regulatory development to go to market in both areas. Oryzon expects to announce more details in the second half of 2021.
Vafidemstat in neurological and inflammatory diseases:
The company is already recruiting patients into the Phase IIb clinical trial of vafidemstat in patients with Borderline Personality Disorder (BPD). The study, called PORTICO, is a multicenter, double-blind, randomized, placebo-controlled Phase IIb study to evaluate the efficacy and safety of vafidemstat in patients with BPD. The trial has two primary objectives: reduction of aggression / agitation and overall improvement of the disease. The study will include 156 patients, with 78 patients in each arm, and has a predefined interim analysis to adjust the sample size for excessive variability around endpoints or an unexpectedly high placebo rate. The trial will be carried out in 15-20 centers in Europe and the United States, with three Spanish hospitals activated in this first phase.
After a successful pre-IND meeting with the US Food and Drug Administration (FDA), Oryzon proceeded to submit in the second quarter of 2021 an IND (Investigational New Drug application) application to carry out PORTICO in the United States. The company has received confirmation from the FDA of granting IND clearance to conduct this study.
The company has received approval from the Spanish Agency for Medicines and Health Products (AEMPS) to carry out a Phase IIb clinical trial with vafidemstat in patients with schizophrenia. This Phase IIb study, called EVOLUTION, will evaluate the efficacy of vafidemstat on negative symptoms and cognition in patients with schizophrenia. Recruitment is expected to begin during the summer. This project is partially financed with public funds from the Ministry of Science and Innovation and will be carried out in various Spanish hospitals.
Collaborations in the field of autism continue to advance with researchers at the Seaver Center for Autism Research and Treatment at the Icahn School of Medicine at Mount Sinai Hospital in New York and with the Institute of Medical and Molecular Genetics (INGEMM) at University Hospital La Peace of Madrid. Collaboration in precision medicine in schizophrenia with researchers at Columbia University in New York also continues. The results of the ongoing pilot characterization studies of patients with specific mutations, which will inform subsequent clinical studies of precision psychiatry with vafidemstat, are expected in the second half of 2021.
Preliminary data from the clinical study of vafidemstat in critically ill patients with Covid-19, called ESCAPE, were presented at the 31st European Congress of Clinical Microbiology and Infectious Diseases, ECCMID-2021. This was an open-label, randomized, double-arm Phase II trial to evaluate the efficacy and tolerability of vafidemstat in combination with standard treatment used in hospitals, to prevent progression to acute Respiratory Distress Syndrome, which recruited 60 patients. Vafidemstat was safe and well tolerated in severe CoVID-19 patients. The anti-inflammatory effects of vafidemstat have been confirmed in severe CoVID-19 patients. Vafidemstat reduced the exacerbated activation of CD4 + T cells and reduced the release of inflammatory cytokines. There was no significant difference in the number of deaths between the two arms of the study and the patients in both arms of the study recovered quickly.