Here, I just sent this to beeandhc in a pm.
An Effective and Safe Covid-19 Treatment Waiting for FDA Approval
Cytodyn is seeking Emergency Use Authorization from the FDA for its monoclonal antibody, Leronlimab, for the treatment of COVID-19.
Cytodyn Inc, a biopharma located in Vancouver, Washington, submitted phase 2 trial results of leronlimab in patients with moderate to mild COVID-19 to the FDA. Based on the strong efficacy data and long-established safety profile of the drug, the company is seeking EUA for "unmet need" in COVID-19. They have also submitted and requested approval in the UK.
If granted, leronlimab would be the first drug authorized to treat mild-to-moderate COVID-19 patients and only the third COVID-19 treatment authorized overall.
It is difficult to prove efficacy in the mild/moderate patient population because many of these patients recover organically with minimal intervention.
However, this clinical trial clearly demonstrated:
• A statistically significant (p value .0223) or 2.5X improvement between treated patients versus placebo patients in NEWS2. (NEWS2 or National Early Warning Score2 is a standardized clinical scoring system developed to detect deterioration in acutely ill patients.)
• A clinically significant improvement at day 3 in total symptom score
• 64% fewer severe adverse events for leronlimab-treated patients versus those on placebo
Leronlimab has an excellent safety profile, already documented in trials with 800+ HIV patients.
It is cost-effective and available via subcutaneous injection, versus costly in-patient treatment.
Additionally, Leronlimab has shown anecdotal evidence of efficacy in reducing mortality in the severe/critical COVID-19 population in over 70 emergency use indication patients. A phase 3 trial is currently ongoing for this cohort, with an interim analysis of the data due in the coming weeks.
Leronlimab has also shown early indication of efficacy in a whole host of diseases (including HIV, Cancer, and NASH) and the company is actively running trials on several of them.
This is an important and timely development, as currently there are extremely limited options for the clinical treatment of COVID-19 patients, and leronlimab can begin saving lives immediately.
Please reach out to the company for more information.
www.cytodyn.com
Tel: 360-980-8524
Melissa Dodd, Communications Director: melissa@melissadodd.com
Cristina De Leon, Assistant: cdeleon@cytodyn.com
Nader Pourhassan PhD, CEO: npourhassan@cytodyn.com
Scott Kelly, MD, CMO: skelly@cytondyn.com
Helpful links:
https://www.cytodyn.com/newsroom/press-releas...ne-results
https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
https://www.cytodyn.com/newsroom/press-releas...dation-for
https://www.targetedonc.com/view/leronlimab-s...o-moderate
https://clinicaltrials.gov/ct2/results?cond=&...&dist=
https://www.youtube.com/watch?v=tPMHZiR_htQ
https://www.medrxiv.org/content/10.1101/2020....1.full.pdf
https://www.montefiore.org/body.cfm?id=1738&a...p;ref=1746
An Effective and Safe Covid-19 Treatment Waiting for FDA Approval
Cytodyn is seeking Emergency Use Authorization from the FDA for its monoclonal antibody, Leronlimab, for the treatment of COVID-19.
Cytodyn Inc, a biopharma located in Vancouver, Washington, submitted phase 2 trial results of leronlimab in patients with moderate to mild COVID-19 to the FDA. Based on the strong efficacy data and long-established safety profile of the drug, the company is seeking EUA for "unmet need" in COVID-19. They have also submitted and requested approval in the UK.
If granted, leronlimab would be the first drug authorized to treat mild-to-moderate COVID-19 patients and only the third COVID-19 treatment authorized overall.
It is difficult to prove efficacy in the mild/moderate patient population because many of these patients recover organically with minimal intervention.
However, this clinical trial clearly demonstrated:
• A statistically significant (p value .0223) or 2.5X improvement between treated patients versus placebo patients in NEWS2. (NEWS2 or National Early Warning Score2 is a standardized clinical scoring system developed to detect deterioration in acutely ill patients.)
• A clinically significant improvement at day 3 in total symptom score
• 64% fewer severe adverse events for leronlimab-treated patients versus those on placebo
Leronlimab has an excellent safety profile, already documented in trials with 800+ HIV patients.
It is cost-effective and available via subcutaneous injection, versus costly in-patient treatment.
Additionally, Leronlimab has shown anecdotal evidence of efficacy in reducing mortality in the severe/critical COVID-19 population in over 70 emergency use indication patients. A phase 3 trial is currently ongoing for this cohort, with an interim analysis of the data due in the coming weeks.
Leronlimab has also shown early indication of efficacy in a whole host of diseases (including HIV, Cancer, and NASH) and the company is actively running trials on several of them.
This is an important and timely development, as currently there are extremely limited options for the clinical treatment of COVID-19 patients, and leronlimab can begin saving lives immediately.
Please reach out to the company for more information.
www.cytodyn.com
Tel: 360-980-8524
Melissa Dodd, Communications Director: melissa@melissadodd.com
Cristina De Leon, Assistant: cdeleon@cytodyn.com
Nader Pourhassan PhD, CEO: npourhassan@cytodyn.com
Scott Kelly, MD, CMO: skelly@cytondyn.com
Helpful links:
https://www.cytodyn.com/newsroom/press-releas...ne-results
https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
https://www.cytodyn.com/newsroom/press-releas...dation-for
https://www.targetedonc.com/view/leronlimab-s...o-moderate
https://clinicaltrials.gov/ct2/results?cond=&...&dist=
https://www.youtube.com/watch?v=tPMHZiR_htQ
https://www.medrxiv.org/content/10.1101/2020....1.full.pdf
https://www.montefiore.org/body.cfm?id=1738&a...p;ref=1746
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