https://www.cytodyn.com/newsroom/press-releas...ts-phase-2
CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval
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August 17, 2020 6:00am EDT
The Top-line Report has been sent to the regulatory authorities in Mexico, and will be provided to U.K. MHRA, and E.U. EMA, with requests for emergency use approval
CytoDyn is preparing a Phase 3 protocol for leronlimab use in long-hauler COVID-19 individuals
VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company announced today it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval.
In addition, CytoDyn has sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines.
Along with the above activities, CytoDyn has been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. The Company is preparing a Phase 3 protocol and will file it as soon as possible.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19. We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”
CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval
Download as PDF
August 17, 2020 6:00am EDT
The Top-line Report has been sent to the regulatory authorities in Mexico, and will be provided to U.K. MHRA, and E.U. EMA, with requests for emergency use approval
CytoDyn is preparing a Phase 3 protocol for leronlimab use in long-hauler COVID-19 individuals
VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company announced today it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn has sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines.
Along with the above activities, CytoDyn has been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. The Company is preparing a Phase 3 protocol and will file it as soon as possible.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19. We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”
