Based on the call, here is a re-written press release focusing on the leronlimab body of work:
Leronlimab in COVID: Program Builds with Actionable Phase 2 Results in Mild/Moderate Patients; Severe/Critical Phase 2b/3 Trial Nears Interim Analysis Enrollment
CytoDyn today filed outcome data with the FDA regarding an 84-patient multi-center Phase 2 randomized controlled trial in mild-to-moderate COVID-19 patients.
The company believes the results justify early approval, and has requested that from the FDA. If not, it believes it will be granted a Phase 3 trial with minor changes informed by the current results. Either outcome is a significant success from a mid-sized trial in a population where most patients recover from symptoms by day 14.
Results highlights are as follows:
** The primary endpoint, an index of the severity of four symptoms at day 14, improved by a clinically important, but not statistically significant amount versus controls. Among the sicker cohort, the day 3 change reached significance, reflecting earlier symptom resolution.
** The “National Early Warning Score 2,” or NEWS2, showed a statistically significant improvement at 3, 7 and 14 days. P-values were .02, .03 and .02. At day 14, 50% of those treated improved on this score, versus only 20% for controls. NEWS2 is an index of 7 objective parameters that is currently in use for hospital patient triage. It was recently shown to have high sensitivity and specificity to progression to severe disease.
** There were 64% fewer severe adverse events ("SAEs”) (p<.04) in the treatment group, While SAEs are typically considered a drug safety issue, in the COVID-19 environment they largely reflect disease progression and as such could be a valid efficacy endpoint. There were no drug-related SAEs in the leronlimab group.
There are currently 175 patients enrolled in a Phase 2B/3 multi-center randomized controlled trial of severe-to-critical COVID-19 patients.
** At 195 patients, the company will perform a previously-specified interim analysis of the data. Because of leronlimab’s superior safety record, this is the “trial of the sickest,” as it includes patients that would be excluded from other trials. The primary end-point is mortality at 28 days.
** The company believes the patient population of this trial will resemble that of its third set of COVID-19 data: its early, highly successful 60 patient emergency IND program. In the largest subset of that group - 31 patients at UCLA - under 15% of severe patients and 30% of critical patients died. After that EIND program, UCLA became a treatment site for both of the above trials.
