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Oryzon Genomics presented preliminary data from the Phase II ESCAPE trial on vafidemstat, showing its safety and anti-inflammatory effects in COVID-19 patients. Conducted from May 2020 to March 2021, the study involved 60 patients and found that vafidemstat, administered alongside standard care, resulted in better control of inflammatory responses and a lower rate of patients requiring mechanical ventilation (65.5% vs. 77.4%). Adverse events were mild, with no severe complications reported. The company aims to further analyze these findings to evaluate vafidemstat's potential in treating severe COVID-19.
Oryzon Genomics, a clinical-stage biopharmaceutical company specializing in epigenetics, is set to present new clinical data at multiple international conferences in June and July. CEO Dr. Carlos Buesa will showcase company updates at the Emerging Biotech Company Showcase on June 23 and hold investor meetings at the Spring European Virtual MidCap Event on June 24-25. Additionally, preliminary data from the Phase II trial ESCAPE on vafidemstat for COVID-19 patients will be presented at ECCMID-2021 on July 9. Oryzon emphasizes its strong pipeline including vafidemstat and iadademstat.
Oryzon Genomics has announced that its Investigational New Drug application for vafidemstat has been approved by the FDA, enabling a Phase IIb clinical trial for treating Borderline Personality Disorder (BPD). The trial, named PORTICO, aims to include approximately 160 patients across Europe and the US, focusing on reducing agitation and aggression. The company cites positive preclinical results supporting vafidemstat's efficacy in treating BPD without common antipsychotic side effects. This milestone enhances Oryzon's US clinical activities and positions it well in a market with significant unmet needs.
Oryzon Genomics presented promising data from its Phase IIa ALICE trial for iadademstat combined with azacitidine in elderly AML patients. The trial showed an 83% objective response rate (ORR), with 67% achieving complete remission. Notably, the longest remission lasted 858 days. The mean time to response was only 29 days, indicating rapid efficacy. The combination therapy demonstrated a good safety profile, with only two serious adverse events reported. Oryzon aims to expand iadademstat's use in leukemia treatment through ongoing trials.
Oryzon Genomics will present new clinical data and participate in several notable virtual conferences from May to June 2021, including BioEquity Europe and the European Hematology Association congress. Key presentations include the ALICE Phase II trial update for iadademstat in acute myeloid leukemia (AML), demonstrating efficacy when combined with azacitidine. The company is recognized as a leader in epigenetics, focusing on unmet medical needs in hematologic and neurological diseases.
Oryzon Genomics, a clinical-stage biopharmaceutical company, reported its Q1 2021 results, highlighting significant progress in epigenetic therapies. The enrollment of the first patient in a Phase IIb trial for vafidemstat in borderline personality disorder and continued recruitment in the ALICE trial for iadademstat in acute myeloid leukemia are notable advancements. The company ended Q1 with $45.2 million in cash, ensuring funding until Q1 2023. However, it reported a net loss of $2.04 million, an increase from the prior year, reflecting higher R&D expenditures.
Oryzon Genomics has initiated a preclinical collaboration with the Seaver Autism Center at Mount Sinai to evaluate the effects of LSD1 inhibition on autism in Shank3 deficient mice. This collaboration aims to test vafidemstat, an LSD1 inhibitor in Phase II development, which has shown promise in treating various psychiatric disorders. The SHANK3 gene defect leads to Phelan-McDermid Syndrome, affecting cognitive functions. Oryzon's CEO expressed optimism about the potential impact of vafidemstat for patients suffering from autism and related disorders.
Oryzon Genomics has initiated the PORTICO Phase IIb clinical trial of vafidemstat for Borderline Personality Disorder (BPD) in Europe and the U.S. This trial is significant as it is the first interventional study in a real-world BPD patient population, aiming to reduce aggression and agitation while improving overall BPD symptoms. The multi-center, randomized, placebo-controlled trial will recruit 156 patients across 20 sites and is expected to complete recruitment in about 18 months. Previous trials indicate vafidemstat is safe and well-tolerated, with promising preliminary results.
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