In updated results from phase II portion of a phase II/III trial, follow-up overall survival data from the cohort of non-mechanically ventilated patients with severe respiratory insufficiency associated with COVID-19 pneumonia and inflammation through Day 90 demonstrated persistent clinical effect, confirming and extending the previously-reported Day 29 data. At Day 29, mavrilimumab did not show a reduction in death in the cohort of mechanically-ventilated patients. In earlier reported results from patients with severe respiratory insufficiency associated with COVID-19 pneumonia and inflammation in 39 evaluable patients showed that at the 28-day follow-up period, mavrilimumab-treated patients experienced earlier and improved clinical outcomes than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations and no deaths. The data was evidenced by the magnitude of severe hypoxia and elevated inflammatory markers, such as C-reactive protein and interleukin-6. Mavrilimumab-treated patients exhibited 0% (n=0) incidence of death, relative to a 27% (n=7) death incidence viewed in control-group patients (p=0.046 for time to death). 8% (n = 1/13) of mavrilimumab-treated patients progressed to mechanical ventilation by day 28, compared to 35% (n = 9/26) of control-group patients who progressed to mechanical ventilation or died (p = 0.077). 100% (n = 13/13) of mavrilimumab-treated patients and 65% (n = 17/26) of control-group patients attained the clinical improvement endpoint (defined as improvement of = 2 categories on a 7-point scale for assessment of clinical status) by Day 28 (p=0.0001). Fever resolved in 91% (n = 10/11 febrile patients) of mavrilimumab-treated patients by day 14, compared to 61% (n=11/18 febrile patients) of control-group patients (p = 0.0093). Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status. Earlier results showed that, mavrilimumab-treated patients reached the endpoint earlier relative to control-group patients (median [95% CI]: 8.0 [5.0–11.0] days versus NE (not estimable) [11.0–NE], p = 0.001). Consequently, mavrilimumab-treated patients experienced a faster discharge from the hospital, as compared with the control-group patients (median [95% CI]: 10.0 [9.0–12.0] days vs. NE [12.0–NE], p=0.013). Eight% (n=1) and 35% (n=9) of mavrilimumab-treated and control group-treated patients received mechanical ventilation (p=0.077 for time to mechanical ventilation or death). Earlier results from seven COVID-2019 infections patients treated with mavrilimumab were consistent with the previous data. One of the 7 patients was electively intubated and subsequently returned to low-level supplemental oxygen. All 13 patients reported clinical improvment and 12 out of 13 patients returned home. Earlier data showed that within one to three days all six patients showed an early resolution of fever and improvement in oxygenation. None of the patients required mechanical ventilation ^{[1] [2] [3] [4]} .

Data from a clinical trial in COVID-2019 infections in 39 evaluable patients showed that Mavrilimumab displayed a well-tolerated safety profile in all patients, bereft of infusion reactions ^{[1] [2]} .