Athersys (ATHX) Announces Release of Data from Placebo-Controlled Clinical Trial Evaluating Multi-Strain Cell Therapy for Acute Respiratory Distress Syndrome

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Athersys, Inc. (NASDAQ: ATHX) today announced that a manuscript reporting data from the company’s MUST-ARDS clinical trial has been published in the peer-reviewed journal Intensive care medicine. MUST-ARDS was a randomized, double-blind, placebo-controlled phase 1/2 trial evaluating the safety and efficacy of MultiStem® cell therapy (invimestrocel) in patients with acute respiratory distress syndrome (ARDS ). By recruiting patients from 12 intensive care units in the UK and US, the study confirmed that intravenous administration of MultiStem cell therapy was well tolerated in critically ill patients at the onset of moderate ARDS. to severe. The trial also assessed several efficacy endpoints, including mortality, release of mechanical ventilation, discharge from intensive care, and quality of life (QoL) in survivors over a full year of recovery. The mechanisms of action were further explored by comparing acute changes in plasma biomarkers of inflammatory and pulmonary lesions in study participants treated with MultiStem and placebo. The results of this study served as the basis for the Food and Drug Administration (FDA) to grant the company’s ARDS program the Advanced Therapy in Regenerative Medicine (RMAT) and the Fast Track designation. The open access publication can be viewed online at the following link: https://link.springer.com/content/pdf/10.1007/s00134-021-06570-4.pdf.

Highlights of the publication, including new and previously disclosed data:

  • MultiStem treatment was well tolerated in this clinical trial, with no serious allergic or adverse reactions associated with cell therapy in any cohort during one year of follow-up;
  • Significantly higher median ICU and ventilator-free days (VFD) among MultiStem cell recipients compared to the placebo group at the 28-day baseline;
  • Lower all-cause mortality in the MultiStem treatment group compared to the placebo group;
  • Quality of life results, assessed by the EQ-5D-3L on days 28, 90 and 365, showed better recovery in survivors who received MultiStem treatment compared to those who received placebo;
  • Decreases in several pro-inflammatory plasma biomarkers were observed in the cell treatment group through day 7 compared to increases in placebo recipients; and
  • Similar acute plasma biomarker responses to MultiStem, including decreases in the pro-inflammatory cytokines IL-1beta, TNFα, IL-6, IFN-gamma, and IL-2, have been observed following treatment for ischemic stroke.

In addition (not reported in the published manuscript), preliminary analyzes of pooled data from the MUST-ARDS study and the recently completed ONE-BRIDGE study, which was conducted by Athersys partner HEALIOS KK (Healios ), in Japan, supports the potential clinically significant benefit of MultiStem as a treatment for patients with ARDS. These pooled randomized data sets include 40 patients with non-COVID ARDS treated with MultiStem cell therapy and 20 patients with ARDS treated with placebo or receiving standard care. Analysis of covariance, adjusted for baseline severity, age, and study participation, revealed an estimate of greater 5.4 (90% confidence interval 0.48- 10.32; bilateral p = 0.07) VFD in MultiStem recipients compared to the control group. Similar analyzes also supported lower mortality in the MultiStem treatment group. Analyzes of aggregated data are available on the Company’s corporate presentation at this link: https://s23.q4cdn.com/674737627/files/11-02-2021-ATHX-Corp-Investor-Presentation.pdf.

“The MUST-ARDS study, completed before the emergence of COVID-19 as a human disease, was an important contribution to the field of cell therapy in the treatment of ARDS. The trial confirmed the tolerability of MultiStem infusion in critically ill adults with severe hypoxemic respiratory failure, and often other coincident organ failure syndromes, and showed very encouraging signs of improved results. that matter to patients and their families, ”commented Dr. Eric Jenkins, study co-author, senior medical director and head of clinical programs at Athersys.

“The results of this study, previously presented only as an oral summary, have served as the basis for advancing the ONE-BRIDGE ARDS trial of Healios and our own pivotal MACoVIA trial of MultiStem for the treatment of ARDS resulting from COVID and other serious infections. Although the study was small in size and therefore lacked the power to provide firm conclusions on efficacy, the trial provided a solid basis for safety and convinced MultiStem could be an effective immunomodulatory therapy. for this hitherto incurable and high morbidity inflammatory lung lesion syndrome. These results have encouraged Athersys, Healios, our clinical collaborators and others in the field to advance cell therapy for the treatment of ARDS in confirmatory and advanced clinical trials. It is important that these results are now available in the peer-reviewed literature. I would like to thank our co-authors, the MUST-ARDS clinical research teams, and, above all, the patients and their families, who on their behalf have chosen, in their most desperate vulnerability, to contribute to the advancement of care. medical for future patients, ”concluded Dr. Jenkins.

There remains a great need for a safe treatment option that can reduce the mortality of patients who develop ARDS, accelerate recovery, and improve the quality of life of survivors. The MUST-ARDS study demonstrated the safety and tolerability of intravenous administration of MultiStem at doses up to 900 million cells in patients with ARDS. Study data, as well as preclinical data, suggest that MultiStem may simultaneously modulate multiple host responses to tissue damage, including downregulation of hyperinflammatory responses, stimulation of tissue repair, and restoration of tissue damage. balance of the immune system, and support the rationale for conducting a further, larger study. size study to assess effectiveness. The Company’s MACoVIA study is a multicenter, randomized, double-blind, placebo-controlled, phase 2/3 trial to investigate the therapeutic efficacy of MultiStem for the treatment of pathogen-induced ARDS.

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