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Posted On: 03/09/2021 11:16:50 AM
Post# of 148863
We are all disappointed that we did not have grand-slam results. But these results are substantial and IMO will undoubtedly lead to an approval in the future.
Here is a summary of the best results directly quoted from the 8k
https://www.cytodyn.com/investors/sec-filings...ngs?page=1
£ 65 years: All-cause mortality among £ 65 years age group was 10% (17 out of 171 subjects died) within 28 days of treatment initiation in leronlimab + SoC group compared to 15% (14 out of 96 subjects died) in placebo + SoC group (Table 4-5). This is approximately a 32% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone.
£ 65 years: All-cause mortality among £ 65 years age group was 10% (3/29) within 28 days of treatment initiation in leronlimab + SoC group compared to 27% (4/15) in placebo + SoC group (Table 4-
. This is approximately a 61% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in £ 65 years age group in the critically ill population.
Leronlimab, when added on these “commonly used treatment”, seems to provide additional survival benefit at Day 28. Mortality rate was 17% (34/205) in subjects receiving leronlimab + “commonly used treatment” compared to 23% (24/104) in subjects who received “commonly used treatments” alone in the placebo group in the overall mITT population, a relative reduction in mortality by approximately 28%. This was statistically significant with p value of 0.0319 using the logit model. (Table 4-9).
£ 65 years: All-cause mortality rate was 6% (9/143) in subjects receiving leronlimab + “commonly used treatment” compared to1 5% (12/78) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of overall mITT population, a relative reduction of approximately 59%. (Table 4-11).
Majority of the critically ill patients received these medications (54/62). Mortality rate was 25% (9/36) in subjects receiving leronlimab + “commonly used treatment” compared to 39% (7/18) in subjects who received “commonly used treatments” alone in the placebo group in the critically ill population. This is approximately a 36% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the critically ill population. (Table 4-12).
£ 65 years: All-cause mortality rate was 8% (2/26) in subjects receiving leronlimab + “commonly used treatment” compared to 29% (4/14) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of critically ill population. This is approximately a 73% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the £ 65 years age group of critically ill population. (Table 4-14).
£ 65 years: Among participants in £ 65 years age group who received dexamethasone as prior or concomitant SoC treatment for COVID-19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as SoC therapy [6% (6/101) vs 13% (7/56)] in the overall mITT population. This is approximately a 53% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone in £ 65 years age group of the overall mITT population.
> 65 years: A numerically higher proportion of patients were discharged from hospital alive in the leronlimab + SoC (32%) vs placebo + SoC (21%) in >65 years age group. (Table 4-20A). This is approximately a 54% relative improvement or higher probability of discharged alive from hospital with leronlimab group compared to placebo (SoC alone) group. The results of an additional analysis using multiple imputation for missing data is presented in Table 4-20B.
28% (12/43) of the critically-ill population (i.e., on invasive mechanical ventilation/intubated at baseline) who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 11% (2/19) patients in the placebo + SoC group (Table 4-22), a relative improvement of approximately 166% in the proportion of patients discharged within 28 days in leronlimab group compared to SoC alone (P-value of 0.0824).
£ 65 years: 31% (9/29) of the critically-ill population in £ 65 years age group who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 13% (2/15) of the patients in the placebo + SoC group (Table4 -24). This is a relative improvement of approximately 133% in participants who received leronlimab compared to the placebo group.
The average length of hospital stay was lower in leronlimab + SoC group (33 days) compared to the placebo + SoC group (39 days) in the critically ill population. This was statistically significant with p value of 0.0050 using the Rank-ANCOVA model. (Table 4-34).
Here is a summary of the best results directly quoted from the 8k
https://www.cytodyn.com/investors/sec-filings...ngs?page=1
£ 65 years: All-cause mortality among £ 65 years age group was 10% (17 out of 171 subjects died) within 28 days of treatment initiation in leronlimab + SoC group compared to 15% (14 out of 96 subjects died) in placebo + SoC group (Table 4-5). This is approximately a 32% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone.
£ 65 years: All-cause mortality among £ 65 years age group was 10% (3/29) within 28 days of treatment initiation in leronlimab + SoC group compared to 27% (4/15) in placebo + SoC group (Table 4-
. This is approximately a 61% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in £ 65 years age group in the critically ill population. Leronlimab, when added on these “commonly used treatment”, seems to provide additional survival benefit at Day 28. Mortality rate was 17% (34/205) in subjects receiving leronlimab + “commonly used treatment” compared to 23% (24/104) in subjects who received “commonly used treatments” alone in the placebo group in the overall mITT population, a relative reduction in mortality by approximately 28%. This was statistically significant with p value of 0.0319 using the logit model. (Table 4-9).
£ 65 years: All-cause mortality rate was 6% (9/143) in subjects receiving leronlimab + “commonly used treatment” compared to1 5% (12/78) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of overall mITT population, a relative reduction of approximately 59%. (Table 4-11).
Majority of the critically ill patients received these medications (54/62). Mortality rate was 25% (9/36) in subjects receiving leronlimab + “commonly used treatment” compared to 39% (7/18) in subjects who received “commonly used treatments” alone in the placebo group in the critically ill population. This is approximately a 36% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the critically ill population. (Table 4-12).
£ 65 years: All-cause mortality rate was 8% (2/26) in subjects receiving leronlimab + “commonly used treatment” compared to 29% (4/14) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of critically ill population. This is approximately a 73% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the £ 65 years age group of critically ill population. (Table 4-14).
£ 65 years: Among participants in £ 65 years age group who received dexamethasone as prior or concomitant SoC treatment for COVID-19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as SoC therapy [6% (6/101) vs 13% (7/56)] in the overall mITT population. This is approximately a 53% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone in £ 65 years age group of the overall mITT population.
> 65 years: A numerically higher proportion of patients were discharged from hospital alive in the leronlimab + SoC (32%) vs placebo + SoC (21%) in >65 years age group. (Table 4-20A). This is approximately a 54% relative improvement or higher probability of discharged alive from hospital with leronlimab group compared to placebo (SoC alone) group. The results of an additional analysis using multiple imputation for missing data is presented in Table 4-20B.
28% (12/43) of the critically-ill population (i.e., on invasive mechanical ventilation/intubated at baseline) who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 11% (2/19) patients in the placebo + SoC group (Table 4-22), a relative improvement of approximately 166% in the proportion of patients discharged within 28 days in leronlimab group compared to SoC alone (P-value of 0.0824).
£ 65 years: 31% (9/29) of the critically-ill population in £ 65 years age group who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 13% (2/15) of the patients in the placebo + SoC group (Table4 -24). This is a relative improvement of approximately 133% in participants who received leronlimab compared to the placebo group.
The average length of hospital stay was lower in leronlimab + SoC group (33 days) compared to the placebo + SoC group (39 days) in the critically ill population. This was statistically significant with p value of 0.0050 using the Rank-ANCOVA model. (Table 4-34).
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