These trial results are currently being prepared t
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Posted On: 03/08/2021 6:12:41 AM
These trial results are currently being prepared to be submitted for publication
VANCOUVER, Washington, March 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it will release the CD12 clinical trial data via a Form 8-K after the investment community webcast on Monday, March 8, 2021. The Company’s recently completed CD12 Phase 3 trial evaluated leronlimab for the treatment of patients with severe-to-critical COVID-19.
A summary of the key findings from this CD12 Phase 3 trial with leronlimab as a treatment for severe-to-critically ill COVID-19 patients is as follows:
1. Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo for invasive mechanical ventilated critically ill patients.
2. Shortened time to recovery: The average length of hospital stay was lower in leronlimab group compared to placebo/SoC group in the critically ill population with a statistically significant p-value of 0.0050 using the Rank-ANCOVA model.
3. Discharge alive: In addition, the patients who received leronlimab in this group demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.
As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an “age adjustment” analysis was performed, which resulted in the following primary endpoint analysis:
4. Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
5. Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
6. Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.
With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.
After communications with MHRA, Health Canada, and U.S. FDA, CytoDyn has its path to approval by conducting another study of 140 patients in the critically ill population with the same sites as the CD12 and/or more sites added.
VANCOUVER, Washington, March 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it will release the CD12 clinical trial data via a Form 8-K after the investment community webcast on Monday, March 8, 2021. The Company’s recently completed CD12 Phase 3 trial evaluated leronlimab for the treatment of patients with severe-to-critical COVID-19. A summary of the key findings from this CD12 Phase 3 trial with leronlimab as a treatment for severe-to-critically ill COVID-19 patients is as follows:
1. Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo for invasive mechanical ventilated critically ill patients.
2. Shortened time to recovery: The average length of hospital stay was lower in leronlimab group compared to placebo/SoC group in the critically ill population with a statistically significant p-value of 0.0050 using the Rank-ANCOVA model.
3. Discharge alive: In addition, the patients who received leronlimab in this group demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.
As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an “age adjustment” analysis was performed, which resulted in the following primary endpoint analysis:
4. Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
5. Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
6. Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.
With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.
After communications with MHRA, Health Canada, and U.S. FDA, CytoDyn has its path to approval by conducting another study of 140 patients in the critically ill population with the same sites as the CD12 and/or more sites added.
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