POTENTIAL NEW COVID-19 TREATMENT LERONLIMAB BEING TESTED ON CORONAVIRUS PATIENTS
https://www.newsweek.com/potential-new-covid-19-treatment-leronlimab-first-coronavirus-patients-1497226
BY ARISTOS GEORGIOU ON 4/10/20 AT 6:00 AM EDT
Researchers are exploring a potential new treatment for COVID-19 known as leronlimab and have administered the drug for the first time to coronavirus patients in the past few days. Leronlimab is also being investigated for its usefulness against triple-negative breast cancer.
The first two coronavirus patients have been treated with the drug in a Phase II clinical trial, which has been specifically designed to asses the impact of leronlimab on patients with mild-to-moderate forms of the disease, the developer, biotechnology firm CytoDyn, said in a press release earlier this week.
The Phase II trial, which was given the go-ahead by the U.S. Food and Drug Administration (FDA) on March 31, will be used to determine what biological effects the drug has and how safe it is. But before a drug can be approved for use by regulatory bodies, it must pass further trials, which usually involve a higher number of participants and assess the effectiveness of the intervention more rigorously.
According to CytoDyn, the trial, which will be randomized, double-blinded and placebo-controlled, aims to enrol 75 patients. Randomization, the use of placebos and blinding—where one or more parties are kept unaware of which treatments patients received—are all used by researchers to prevent conscious or unconscious bias from affecting the results of the trial.
The company says that leronlimab has been administered recently to 15 severely ill COVID-19 patients—10 at a leading medical centre in New York and five at three other hospitals—all under an EIND, of emergency investigational new drug application, which was granted individually by the FDA.
CytoDyn also said that it is commencing another COVID-19 trial, which will treat more than 340 severely ill patients with leronlimab for two weeks.
"We are encouraged by the positive results demonstrated with leronlimab in the New York patients," Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, said in the press release.
"Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimab's mechanism of action," he said.
Researchers think that the drug may work by calming the aggressive immune response called the "cytokine storm" that occurs in severely ill COVID-19 patients, but further research is needed to determine how effective leronlimab is.
The FDA has already granted leronlimab "Fast Track" designation to explore its efficacy as a treatment for metastatic triple-negative breast cancer as well as HIV. In fact, nine clinical trials have been completed to date in which the drug has been administered to more than 800 people, including one Phase III trial involving HIV patients where leronlimab was combined with standard therapies.
These early trials indicate that potential side effects of the drug may include diarrhea, headache, swollen lymph nodes, high blood pressure, and injection site reactions.
As the COVID-19 pandemic spreads, scientists around the world are scrambling to test the effectiveness of various potential treatments, as well as develop a vaccine. But while efforts are being made to accelerate this process, with some drugs being tried outside of formal studies, randomized controlled trials are still required to truly asses whether or not a given treatment works and if it is safe.
