ORYZON: new advances in vafidemstat in patients with CoVID-19

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Oryzon Genomics today presents preliminary data from the ability of vafidemstat to reduce inflammatory response in CoVID-19 patients of the Phase II ESCAPE trial in the 31st European Congress of Clinical Microbiology and Infectious Diseases, ECCMID-2021, en una comunicacioÌ??n en formato poÌ??ster electroÌ??nico titulada ““ESCAPE trial: Preliminary data on the effect of vafidemstat treatment in the CoVID-19 induced immune response in hospitalized patients”.

In a press release, Oryzon explains that from May 2020 to March 2021, 70 patients were randomized in a study that aimed to evaluate, against a group, the control, safety and efficacy of the administration of vafidemstat on the base treatment (SoC). Glucocorticoids were the most frequent SoC (83% of patients, equally represented in both arms). Most of the patients (69%) were discharged before the first week of treatment in both arms. Four patients were admitted to the ICU (2 in each arm).

Treatment with vafidemstat 2.4 mg / day for 5 days was successful. in an almost complete and sustained occupation of the LSD1 target and remained elevated in most cases until the day of medical discharge.

Treatment was well tolerated, with only 13 adverse events (AE) in 11 subjects during the study, none of them serious. Of these, 9 AE were recorded in the vafidemstat + SoC arm, all mild and considered unrelated to treatment.

Regarding disease control, twenty-four patients (77.4%) in the SoC group required mechanical ventilation compared to 19 (65.5%) in the group treated with vafidemstat + SoC. A total of 6 patients required rescue medication (Tocilizumab): 4 patients (67%) in the SoC group and 2 (33%) treated with vafidemstat + SoC. A patient treated with SoC died. due to CoVID-19 morbidity and none in the group treated with vafidemstat.

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The doctor. Carlos Buesa, CEO of Oryzon, has commented: “Fortunately, the hospital management of seriously ill CoVID-19 patients has improved a lot since the beginning of the pandemic and current basic treatments are effective in reducing mortality. For this reason we have not seen differences in mortality between the two arms , which was the main parameter when the study was designed, but we consider the ESCAPE data as very positive, since the vafidemstat arm has had better anti-inflammatory indicators and this is a clear example of the potential of the drug. program in controlling for the escalation of serious events in CoVID-19 patients. The company will finish discussing data with the study’s principal investigators in the coming months. Oryzon is not a infectious disease company, but given the severity of the disease and the pandemic, we will assess the potential of the drug to improve the treatment of CoVID-19 patients and possible next steps. “

Vafidemstat produced significant effects on the immune response induced by CoVID-19 infection, both in terms of circulating immune cell populations and inflammatory mediators, including cytokines and chemokines.

In particular, it was observed? a clear tendency to decrease the plasma levels of most of the cytokines evaluated after 5 days of treatment with vafidemstat in comparison with the observed immunosuppressive effect In the SoC-only arm, a clear statistical significance was reached (p

Changes were also observed in several relevant circulating immune cell populations (especially CD4 + T-lymphocytes), revealing that vafidemstat in combination with SoC treatment could help control activation. of T cells by significantly reducing the% of terminal effector cells (TE), memory effector cells (EM) and T-regulatory cells (Treg), which are found very high in patients with severe pneumonia due to CoVID-19.

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