Abivax has treated the first patient in its Phase 2b/3 study of ABX464 in COVID-19 patients at the University Hospital Center in Nice, France (CHU Nice) in a randomized, double-blind, placebo-controlled study, to see the the effects of early treatment in 1034 Covid-19 older or high-risk patients.
Abivax noted that the main goal of the trial is to measure the potential of ABX464 to limit viral replication as well as the severe inflammation that leads to acute respiratory distress syndrome (ARDS). Abivax said it has already received clearance for the study from the French, German, UK, Italian, Brazilian regulatory authorities, and it is awaiting the same from the Spanish and Latin American authorities.
Prof. Hartmut Ehrlich, the CEO of Abivax, is pleased with the miR-AGE trial, how the recruitment looks good. He said that after Brazil, the company is waiting for the regulatory bodies from the rest of the Latin America, pointing out the pandemic has not reached its peak.
He said that the first topline results are expected by the end of the year.
He also mentioned in the press release the enrollment for the second phase of trials for ulcerative colitis and rheumatoid arthritis, as well as the US phase 1/2 trial in hepatocellular carcinoma, are all going as expected.
Prof Ehrlich: “With non-dilutive funding provided by Bpifrance and Société Générale, Abivax’s projects are fully financed until early 2021 and discussions for further, preferably non-dilutive financial options are ongoing.”
“The treatment of the first patient in the miR-AGE trial is an important milestone for Abivax,” added Philippe Pouletty, M.D., Chairman of the Board of Abivax and CEO of Truffle Capital. “While further study centers in Europe are being initiated, we also continue to expand the trial in additional Latin American countries. The already available regulatory and national ethics committee clearance in Brazil make a recruitment start in July realistic, as we are only missing the local ethics approvals. Furthermore, the ongoing preparation of filing in Mexico, Chile and Peru are very important, as the pandemic is still very active in these countries. While we are confident that ABX464 may have a positive impact by reducing the severity of COVID-19 sequelae, we remain prudent on expectations for the miR-AGE trial given the complexities surrounding treatment of COVID-19 disease. Progressing ABX464 development in chronic inflammatory diseases remains Abivax’s corporate priority.”
Eric Cua, Infectiologist at the University Hospital Center (CHU) of Nice, said: “ABX464’s unique triple mode of action could potentially limit the replication of SARS-CoV-2 virus, prevent and treat the cytokine storm or hyper-inflammation – and the ensuing acute respiratory failure syndrome – as well as limit long-term lung injury through tissue repair. Due to ABX464’s easy, once-daily oral administration, we can include hospitalized as well as non-hospitalized COVID-19 patients in this trial. We hope that the findings in this placebo controlled and randomized trial bring us one step closer to a potent treatment for this disease in order to protect especially high-risk patients and avoid tense situations in hospitals and intensive care units in the future.”
Abivax said in the press release ABX464 has already demonstrated impressive efficacy in a Phase 2a trial in another severe inflammatory disease, ulcerative colitis (UC). In this trial, specifically, potent anti-inflammatory effects and tissue healing were observed. The results in UC patients together with the unique molecular mechanism of action of ABX464 support the rationale to use the drug candidate to treat the cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients. Hyper-inflammation in the lung is the primary cause of the respiratory distress and potential death in COVID-19 patients.
ABX464’s molecular action has been shown to upregulate a micro-RNA, miR-124, which is a “physiological brake” on inflammation. It works by down-regulating the multiple chemo- and cytokines involved in the COVID-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17, Abivax said. In addition, unlike other potent anti-inflammatory agents that specifically target single cytokines, ABX464 has not been associated with increased vulnerability to opportunistic infections or a damping down of the immune system, the company’s press release read.