CytoDyn Inc. a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced it intends to submit the results of its newly completed topline report of its CD12 Phase 3 clinical trial data for severe to critically ill COVID-19 patients to various regulatory agencies including but not limited to agencies in India and the Philippines.
A summary of the new key findings from the data of the CD12 Phase 3 clinical trial results, included in the newly completed topline report, consists of the following:
| Efficacy | Safety | |||
| Leronlimab mortality better than placebo | No safety issues in CD12 or CD10 clinical trials | |||
| CD12: Critically ill population (7-day) | 78 | % | CD12: LL arm 21% less AE/patients (AE/all patients) | |
| CD12: Critically ill population (14-day) | 82 | % | CD12: LL arm 3% less SAE/patients (SAE/all patients) | |
| CD12: Critically ill population (21-day) | 50 | % | CD10: LL arm 59% less AE/patients (AE/all patients) | |
| CD12: Critically ill population (28-day) | 31 | % | CD10: LL arm 64% less SAE/patients (SAE/all patients) | |
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 in the table above 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, we 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)
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very thankful for the opportunity to be able to conduct two very crucial clinical trials in Brazil for severe and critically ill COVID-19 patients, which we believe could result in a statistically significant p-value of our primary endpoint leading the way to a potential approval. Although we did not meet our primary endpoint in our CD12 clinical trial in the mITT population, we were still very pleased that we did meet almost all of our secondary endpoints in the critically ill subpopulation of COVID-19 patients. To the best of our knowledge, we are unaware of another drug or therapeutic which has reported results in the critically ill population, in a randomized controlled trial, remotely close to what we reported for the CD12 trial. We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab. We are very confident this approval will happen this year.”