COVID-19: AGC, manufacturing contract from CytoDyn: US FDA, ‘Leronlimab’ / Phase 3 trial
COVID-19:
AGC Biologics:
AGC Biologics (Headquarters: CDMO subsidiary of AGC, USA) has been contracted by CytoDyn to manufacture the drug substance of ‘Leronlimab’.
CytoDyn:
CytoDyn of the United States develops the therapeutic drug candidate “Leronlimab” for the new coronavirus.
The US FDA recently approved a Phase 2b / 3 clinical trial.
“Leron limab”:
“Leronlimab,” developed by CytoDyn, is a therapeutic drug developed for patients with HIV and breast cancer.
Administration of this therapeutic agent to patients with new coronavirus has the effect of suppressing cytokine storm * 2.
It has already been administered to severely ill patients with new coronavirus in the United States, and the effect has been confirmed.
* 1 CDMO:
A company that contracts and develops manufacturing methods in addition to contract manufacturing (Contract Development & Manufacturing Organization)
* 2 Cytokine storm:
A condition in which abnormal increase in blood cytokines occurs due to causes such as infectious diseases and progresses to multiple organ failure
News ｜ AGC
https://www.agc.com/news/detail/1200758_2148.html
CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir
VANCOUVER, Washington,
May 18, 2020 (GLOBE NEWSWIRE)
CytoDyn Inc. (OTC.QB: CYDY),
a late-stage biotechnology company
developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today
announced it will be submitting a protocol to the U.S.FDA for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.
Leronlimab
was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.
Preliminary results from this patient population led to CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio).
CytoDyn
has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.
CytoDyn plans to update the public regarding current eIND results later this week.
CytoDyn Inc. (CYDY)