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Covid variant present in South Africa ‘might evade’ Eli Lilly’s antibody drug: CEO

Dave Ricks, chairman and CEO of Eli Lilly, told CNBC on Tuesday that he expected the company’s Covid-19 antibody drug to be effective against the variant of coronavirus found in the UK

However, he said the exposure observed in South Africa is likely to be more of a challenge.

“The South African variant … is cause for concern. It has more dramatic mutations to the spike protein that these antibody drugs target,” Ricks told Squawk Box. “In theory, it could evade our drugs.”

Eli Lilly’s antibody drug was approved for emergency use by the US Food and Drug Administration in November. The drug is aimed at people recently diagnosed with Covid-19 in hopes of preventing the need for hospitalization. Regeneron’s Covid-19 antibody treatment, which President Donald Trump received after contracting the disease, has also received limited approval from the FDA.

According to Ricks, Eli Lilly wants to work with the FDA to quickly test different versions of antibodies to see if they are against virus variants like the one in South Africa.

“We actually have a large library of these antibodies now that are pre-clinical,” said Ricks. “We could think of a very expedited way to study them in a month or two and then approve their use. That seems like a smart thing because this virus is mutating.”

Discovery of variants

Coronavirus variants originally found in the UK and South Africa have received significant attention in recent weeks. They are believed to be more transmissible – but not more deadly – than previous tribes. Even so, a more contagious virus that leads to more infections could continue to weigh on healthcare systems and lead to more deaths.

The discovery of these mutations also coincides with the introduction of Covid-19 vaccines from drug companies such as Pfizer and BioNTech, as well as Moderna. It has led to some questions about whether the vaccines – along with treatments for the disease – would keep their effectiveness.

In a CNBC interview on Monday, Dr. Ugur Sahin, CEO of BioNTech, confident that his vaccine, manufactured in partnership with Pfizer, will work against the strains of the virus found in the UK and South Africa.

Daniel O’Day, CEO of Gilead Sciences, told CNBC it was testing its remdesivir treatment against these new strains, but said Monday the antiviral drug would likely be effective. Antiviral drugs like remdesivir try to prevent the virus from replicating. In contrast, antibodies like Eli Lillys bind to the virus present in the body and try to neutralize it.

There have been no confirmed cases of the variant, which was first discovered in South Africa in America, but according to the Wall Street Journal, it was discovered in countries like Japan, South Korea, and Switzerland. According to the Centers for Disease Control and Prevention, there have been around 70 confirmed cases of the coronavirus variant in the US that were originally found in the UK.

“It seems clear that Lilly’s single antibody, and likely Regeneron’s cocktail, will stop this as well as the normal variant,” said Ricks of the UK-affiliated tribe. “We haven’t done a clinical study of this effect, but we do have pre-clinical data that strongly suggests that it won’t be a problem.”

Use of antibody therapies

After the FDA approved emergency use for their antibody therapies to Eli Lilly and later Regeneron, problems arose with actually delivering the drug, which requires an intravenous infusion, to Covid patients. In mid-December, CNBC reported that between 5% and 20% of the doses delivered had been administered.

That number is “climbing” now, Ricks said on Monday. He pointed to Alabama as a state where the antibodies are widespread. Alabama “basically runs out and refills every week,” he said.

“There are quite a few” from state to state, Ricks admitted. “We want all states to learn from these practices and really be able to use this medicine, as the benefit is that patients, especially seniors, are kept out of the hospital. We know if you are a senior and have Covid-19 and end up in a hospital hospital bed, the prospects are not good. “

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Health

Eli Lilly’s Alzheimer’s Drug Reveals Promise in Small Trial

In a small clinical trial, an experimental Alzheimer’s drug slowed the rate at which patients lost the ability to think and care for themselves, drug maker Eli Lilly announced on Monday.

The results have not been published in any form and have not been fully reviewed by other researchers. If exactly, it will be the first time a positive result has been found in a so-called phase 2 study, said Dr. Lon S. Schneider, Professor of Psychiatry, Neurology, and Gerontology at the University of Southern California.

Other experimental drugs for Alzheimer’s disease were never tested in phase 2 studies, went straight to larger phase 3 studies, or did not produce positive results. The Phase 3 trials themselves repeatedly had disappointing results.

The two-year study included 272 patients with brain scans that suggest Alzheimer’s disease. Her symptoms ranged from mild to moderate.

The drug donanemab, a monoclonal antibody, attaches to a small portion of the hard plaques in the brain, which are made up of a protein, amyloid, that is characteristic of Alzheimer’s disease. The patients received the drug by infusion every four weeks.

Participants who received the drug had a 32 percent slowdown in the rate of decline compared to those who received a placebo. In six to twelve months, plaques were gone and stayed gone, said Dr. Daniel Skovronsky, scientific director of the company. At this point, the patients were no longer receiving any medication for the duration of the study – they were given a placebo instead.

The small study needs to be replicated, noted Dr. Michael Weiner, a leading Alzheimer’s researcher at the University of California at San Francisco. Even so, “this is big news,” he said. “This gives hope to patients and their families.”

Eli Lilly has not released the relevant data needed for a thorough analysis, said Dr. Cutter. For example, the company only provided percentages describing functional decline among participants, not the actual numbers.

The company will provide this data at a subsequent meeting and in an article in a medical journal, said Dr. Skovronsky. Eli Lilly received the results on Friday and had to report them immediately, he said, as the results may affect Lilly’s stock.

Dr. Schneider, who served on an independent data protection and monitoring body for the study, said he was not allowed to disclose more data than the company provided.

The experiment served as a test for the so-called amyloid hypothesis. The idea is that Alzheimer’s is closely related to amyloid buildup in the brain; If amyloid accumulation can be prevented or reversed, the disease can be prevented or cured.

Drug companies have spent billions of dollars testing anti-amyloid drugs to no avail, leading many experts to believe the hypothesis is wrong – or that the only way to treat Alzheimer’s is to start very early, before clinical ones There are signs of illness.

The Eli Lilly study recruited patients who were not based on symptoms but rather on scans that showed significant buildups of amyloid in their brain. The researchers also looked at a protein, tau, that forms spaghetti-like tangles in the brain after the disease begins.

“We needed mild to moderate entanglement pathology, but not so many entanglements that the disease may no longer be hoped for,” said Dr. Skovronsky.

The primary endpoint or aim of the study was a measurement that combined performance on mental reasoning and memory tests with ratings of participants’ performance in activities of daily living such as dressing and meal preparation.

The main side effect has been seen regularly in patients given experimental monoclonal antibodies to treat Alzheimer’s disease: an accumulation of fluid in the brain. It occurred in nearly 30 percent of patients, said Dr. Skovronsky, but most of them had no symptoms. The effect was seen on brain scans.

During the study, Eli Lilly started a second phase 2 study, Trailblazer 2, in the hope that the initial efforts would produce results. These results are expected in 2023.

Dr. Skovronsky said Eli Lilly will speak to the Food and Drug Administration and regulators in other countries about giving patients access to the drug.

“Sure, the dates are exciting,” he said. “But we have to see what the regulators say.”

For 25 years he has hoped for definitive evidence that the amyloid hypothesis is correct.

“This is what we’ve been waiting for,” said Dr. Skovronsky.