CytoDyn Inc (OTCQB:CYDY) announced that it has executed an exclusive supply and distribution agreement with Chiral Pharma Corporation to supply up to 200,000 vials of leronlimab to critically ill coronavirus (COVID-19) patients in the Philippines.
“Chiral has been working diligently with the Philippine FDA to ensure the regulatory path is cleared so we can provide leronlimab to thousands of critically ill COVID-19 patients under CSP authorization,” CytoDyn CEO Nader Pourhassan said in a statement.
“Upon quick recovery of the first Filipino patient critically ill with COVID-19 treated with leronlimab, Chiral is continuously receiving CSP requests and is hoping to accelerate the availability of leronlimab under CSP to thousands of critically ill COVID-19 patients.”
READ: CytoDyn says its coronavirus long-haulers trial now fully enrolled faster than expected
Pourhassan added: “In parallel, we are using data generated from our CD12 open-label extension to pursue EUAs in multiple countries experiencing surges in critically ill COVID-19 patients. The Company will accelerate manufacturing of leronlimab at Samsung BioLogics upon such approval.”
After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn has initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers.
This trial will evaluate the effects of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term symptoms such as fatigue, cognitive impairment, sleep disorders, and shortness of breath.
If this trial is successful, CytoDyn said it plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Leronlimab blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (nonalcoholic steatohepatitis). The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation.
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