CytoDyn is set to submit the results from the Phase III CD12 clinical trial of Vyrologix (leronlimab-PRO 140), seeking potential regulatory approval for the drug to treat severe to critically ill patients with COVID-19.
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The company will file the results with different regulatory agencies, including in India and the Philippines.
Patients in the CD12 trial were administered only two doses of leronlimab, the first dose at day zero and the second dose at day seven, while results were measured for 28 days (every 7 days).
The results indicate that from day zero to day seven, critically ill patients receiving leronlimab (on day zero) experienced a mortality rate 78% lower than patients receiving placebo. Further, patients receiving the second dose of leronlimab achieved maximum benefit of 82% less mortality.
However, the effects diminished from day 14 to day 21 and from day 21 to day 28, as the mortality rate decreased to 50% and 31%, respectively. This, they believe, was due to patients not being administered leronlimab past day 7.
The secondary endpoints met with statistically significant p-values for the critically ill subpopulation (62 patients) were:
1) All-cause mortality at day 14 (p =0.0233)
2) Proportion of patients achieving a category of 6 or higher on a 7-point ordinal scale at days 14 and 28 (p=0.036 & 0.038)
3) Change in clinical status of subject at day 14 on a 7-point ordinal scale (p=0.02)
4) Length of hospital stay in days (p=0.005)
After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial will evaluate the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC.
It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. If this trial is successful, CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). ■