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CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically
March 5, 2021, 5:47 PM EST
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CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and
Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19
Patients Treated with Leronlimab
VANCOUVER, Washington, March 05, 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, reported today the Phase 3
trial of leronlimab for the treatment of severe-to-critical patients with
COVID-19 demonstrated continued safety, substantial improvement in the
survival rate, and faster hospital discharge in critically ill COVID-19
patients. The trial’s data has been reported to the U.S. Food and Drug
Administration (“FDA”), the U.K.’s Medicines & Healthcare product Regulatory
Agency (“MHRA”) and Health Canada (“HC”), and the Company is in discussions
with each to determine the best path forward for approval of leronlimab for
treatment of COVID-19 in critically ill population. A manuscript of the
trial’s data is being prepared and will be submitted for publication in one or
more major medical journals.
Highlights from the trial’s data for this critically ill population include
the following:
1. Survival benefit: There was a 24% reduction in all-cause mortality
(primary endpoint of the study) in the leronlimab versus placebo.
2. Shortened time to recovery: The average length of hospital stay was
reduced by 6 days for patients who received leronlimab with ”commonly used
COVID-19 treatments,” also referred to as “Standard of Care” or “SoC,”
compared to placebo patients who received SoC only, with a statistically
significant p-value of 0.005.
3. Discharge alive: In addition, patients who received leronlimab
demonstrated an improved probability of "discharged alive" at Day 28 (28%
versus 11%), a 166% better rate than in the placebo group.
Given the size of this critically ill population relative to the trial’s size
(62 out of 384 patients), the Company has concurrently filed an additional
protocol with the FDA using the existing sites from its CD12 trial to quickly
enroll patients in this population during the pendency of these ongoing
regulatory discussions. The Company has continued to enroll patients (45)
through the open-label arm of the CD12 trial, and is working with regulators
here and abroad to expedite this process.
Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung
Transplantation Program, commented, “The CD12 trial results are very promising
and leronlimab may be the only safe medication to help critically ill
patients.”
Scott A. Kelly, M.D., Chairman and Chief Medical Officer, noted, “We believe
this further supports CCR5 as a therapeutic target for immunomodulation and
the importance of the disruption of the CCL5-CCR5 axis via leronlimab-mediated
CCR5 blockade of pro-inflammatory leukocytes and reversal of the cytokine
storm in critical COVID-19 patients.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn,
commented, “Today, there are no approved drugs to effectively address the
unmet medical need for critically ill COVID-19 patients. Our CD12 study
demonstrates leronlimab is particularly effective in treating this patient
population. We believe these results are the best results ever achieved for
this population in a Phase 3 clinical trial. A recently approved IL-6 blocker
used to treat severe to critical hospitalized COVID-19 patients requiring
mechanical ventilation, reduced mortality by 2% compared to the placebo group.
In contrast, leronlimab demonstrated a reduction of 24% in mortality compared
to the SoC treated group, which is 12 times better in reducing all-cause
mortality for critically ill COVID-19 patients. The Company is very excited
about these results and is concurrently working with regulators here and
abroad to expedite leronlimab’s approval to treat COVID-19.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential
indications of leronlimab for critical illnesses. The first indication is a
combination therapy with HAART for HIV-infected patients and the second is for
metastatic triple-negative breast cancer. Leronlimab is an investigational
humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in
HIV infection, tumor metastases, and other diseases, including
NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met
its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination
with standard antiretroviral therapies in HIV-infected treatment-experienced
patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks
CCR5, thus protecting healthy T cells from viral infection by blocking the
predominant HIV (R5) subtype from entering those cells. Leronlimab has been
the subject of nine clinical trials, each of which demonstrated that
leronlimab could significantly reduce or control HIV viral load in humans. The
leronlimab antibody appears to be a powerful antiviral agent leading to
potentially fewer side effects and less frequent dosing requirements compared
with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in
tumor invasion, metastases, and tumor microenvironment control. Increased CCR5
expression is an indicator of disease status in several cancers. Published
studies have shown that blocking CCR5 can reduce tumor metastases in
laboratory and animal models of aggressive breast and prostate cancer.
Leronlimab reduced human breast cancer metastasis by more than 98% in a murine
xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical
trial in metastatic triple-negative breast cancer and was granted Fast Track
designation by the FDA in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell
trafficking to sites of inflammation. It may be crucial in the development of
acute graft-versus-host disease (GvHD) and other inflammatory conditions.
Clinical studies by others further support the concept that blocking CCR5
using a chemical inhibitor can reduce the clinical impact of acute GvHD
without significantly affecting the engraftment of transplanted bone marrow
stem cells. CytoDyn was conducting a Phase 2 clinical study with leronlimab to
support further the concept that the CCR5 receptor on engrafted cells is
critical for the development of acute GvHD, blocking the CCR5 receptor from
recognizing specific immune signaling molecules is a viable approach to
mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab
for the prevention of GvHD. Due to the lack of patients during the COVID-19
pandemic, the Company suspended its Phase 2 trial for acute GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments
for multiple therapeutic indications based on leronlimab, a novel humanized
monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a
critical role in the ability of HIV to enter and infect healthy T-cells. The
CCR5 receptor also appears to be implicated in tumor metastasis and
immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in
combination with standard antiretroviral therapies in HIV-infected
treatment-experienced patients. CytoDyn has been working diligently to refile
its Biologics License Application ("BLA" for this HIV combination therapy
since receiving a Refusal to File in July 2020 and subsequently meeting with
the FDA telephonically to address their written guidance concerning the
filing. CytoDyn expects to refile its BLA in the first half of calendar year
2021.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a
once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a
registration-directed study of leronlimab monotherapy indication. If
successful, it could support a label extension. Clinical results to date from
multiple trials have shown that leronlimab can significantly reduce viral
burden in people infected with HIV. No drug-related serious site injection
reactions reported in about 800 patients treated with leronlimab and no
drug-related SAEs reported in patients treated with 700 mg dose of leronlimab.
Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy
can prevent viral escape in HIV-infected patients; some patients on leronlimab
monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in
metastatic triple-negative breast cancer. More information is at
www.cytodyn.com.
Business
CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically
March 5, 2021, 5:47 PM EST
SHARE THIS ARTICLE
Share
Tweet
Post
CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and
Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19
Patients Treated with Leronlimab
VANCOUVER, Washington, March 05, 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, reported today the Phase 3
trial of leronlimab for the treatment of severe-to-critical patients with
COVID-19 demonstrated continued safety, substantial improvement in the
survival rate, and faster hospital discharge in critically ill COVID-19
patients. The trial’s data has been reported to the U.S. Food and Drug
Administration (“FDA”), the U.K.’s Medicines & Healthcare product Regulatory
Agency (“MHRA”) and Health Canada (“HC”), and the Company is in discussions
with each to determine the best path forward for approval of leronlimab for
treatment of COVID-19 in critically ill population. A manuscript of the
trial’s data is being prepared and will be submitted for publication in one or
more major medical journals.
Highlights from the trial’s data for this critically ill population include
the following:
1. Survival benefit: There was a 24% reduction in all-cause mortality
(primary endpoint of the study) in the leronlimab versus placebo.
2. Shortened time to recovery: The average length of hospital stay was
reduced by 6 days for patients who received leronlimab with ”commonly used
COVID-19 treatments,” also referred to as “Standard of Care” or “SoC,”
compared to placebo patients who received SoC only, with a statistically
significant p-value of 0.005.
3. Discharge alive: In addition, patients who received leronlimab
demonstrated an improved probability of "discharged alive" at Day 28 (28%
versus 11%), a 166% better rate than in the placebo group.
Given the size of this critically ill population relative to the trial’s size
(62 out of 384 patients), the Company has concurrently filed an additional
protocol with the FDA using the existing sites from its CD12 trial to quickly
enroll patients in this population during the pendency of these ongoing
regulatory discussions. The Company has continued to enroll patients (45)
through the open-label arm of the CD12 trial, and is working with regulators
here and abroad to expedite this process.
Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung
Transplantation Program, commented, “The CD12 trial results are very promising
and leronlimab may be the only safe medication to help critically ill
patients.”
Scott A. Kelly, M.D., Chairman and Chief Medical Officer, noted, “We believe
this further supports CCR5 as a therapeutic target for immunomodulation and
the importance of the disruption of the CCL5-CCR5 axis via leronlimab-mediated
CCR5 blockade of pro-inflammatory leukocytes and reversal of the cytokine
storm in critical COVID-19 patients.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn,
commented, “Today, there are no approved drugs to effectively address the
unmet medical need for critically ill COVID-19 patients. Our CD12 study
demonstrates leronlimab is particularly effective in treating this patient
population. We believe these results are the best results ever achieved for
this population in a Phase 3 clinical trial. A recently approved IL-6 blocker
used to treat severe to critical hospitalized COVID-19 patients requiring
mechanical ventilation, reduced mortality by 2% compared to the placebo group.
In contrast, leronlimab demonstrated a reduction of 24% in mortality compared
to the SoC treated group, which is 12 times better in reducing all-cause
mortality for critically ill COVID-19 patients. The Company is very excited
about these results and is concurrently working with regulators here and
abroad to expedite leronlimab’s approval to treat COVID-19.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential
indications of leronlimab for critical illnesses. The first indication is a
combination therapy with HAART for HIV-infected patients and the second is for
metastatic triple-negative breast cancer. Leronlimab is an investigational
humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in
HIV infection, tumor metastases, and other diseases, including
NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met
its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination
with standard antiretroviral therapies in HIV-infected treatment-experienced
patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks
CCR5, thus protecting healthy T cells from viral infection by blocking the
predominant HIV (R5) subtype from entering those cells. Leronlimab has been
the subject of nine clinical trials, each of which demonstrated that
leronlimab could significantly reduce or control HIV viral load in humans. The
leronlimab antibody appears to be a powerful antiviral agent leading to
potentially fewer side effects and less frequent dosing requirements compared
with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in
tumor invasion, metastases, and tumor microenvironment control. Increased CCR5
expression is an indicator of disease status in several cancers. Published
studies have shown that blocking CCR5 can reduce tumor metastases in
laboratory and animal models of aggressive breast and prostate cancer.
Leronlimab reduced human breast cancer metastasis by more than 98% in a murine
xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical
trial in metastatic triple-negative breast cancer and was granted Fast Track
designation by the FDA in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell
trafficking to sites of inflammation. It may be crucial in the development of
acute graft-versus-host disease (GvHD) and other inflammatory conditions.
Clinical studies by others further support the concept that blocking CCR5
using a chemical inhibitor can reduce the clinical impact of acute GvHD
without significantly affecting the engraftment of transplanted bone marrow
stem cells. CytoDyn was conducting a Phase 2 clinical study with leronlimab to
support further the concept that the CCR5 receptor on engrafted cells is
critical for the development of acute GvHD, blocking the CCR5 receptor from
recognizing specific immune signaling molecules is a viable approach to
mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab
for the prevention of GvHD. Due to the lack of patients during the COVID-19
pandemic, the Company suspended its Phase 2 trial for acute GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments
for multiple therapeutic indications based on leronlimab, a novel humanized
monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a
critical role in the ability of HIV to enter and infect healthy T-cells. The
CCR5 receptor also appears to be implicated in tumor metastasis and
immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in
combination with standard antiretroviral therapies in HIV-infected
treatment-experienced patients. CytoDyn has been working diligently to refile
its Biologics License Application ("BLA"
for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with
the FDA telephonically to address their written guidance concerning the
filing. CytoDyn expects to refile its BLA in the first half of calendar year
2021.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a
once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a
registration-directed study of leronlimab monotherapy indication. If
successful, it could support a label extension. Clinical results to date from
multiple trials have shown that leronlimab can significantly reduce viral
burden in people infected with HIV. No drug-related serious site injection
reactions reported in about 800 patients treated with leronlimab and no
drug-related SAEs reported in patients treated with 700 mg dose of leronlimab.
Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy
can prevent viral escape in HIV-infected patients; some patients on leronlimab
monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in
metastatic triple-negative breast cancer. More information is at
www.cytodyn.com.
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