As the obesity epidemic in America worsened throughout the years, many biotechs cropped up hoping to develop weight-loss drugs that would help stem this tide. But now, Novo Nordisk’s diabetes cash cow semaglutide is showing such startlingly effective results in obesity that it may have a head start in cornering the market.
In nearly a 2,000-person trial, participants injected themselves with either semaglutide or placebo for 68 weeks. Patients in the drug arm saw an average 15% weight loss, compared with just 2.4% on placebo, and almost a third lost more than 20% of their weight. Researchers published the data Wednesday in the New England Journal of Medicine, and all p-values came out to p<0.001.
Robert Kushner
Those results mark a “game-changer” in an obesity field that, to this point, has not seen results as effective as these, study leader Robert Kushner told the New York Times.
The data also mark an important milestone in regards to diabetes. There are no approved obesity medications in the US that also prevent or treat type 2 diabetes. But given that semaglutide is already OK’ed in that indication, the results suggest Novo could end up killing two birds with one stone here.
In an exploratory endpoint, clinicians looked at patients classified as “prediabetes” and saw numerical improvements in glycated hemoglobin levels. Among those in that group, 84.1% in the semaglutide arm saw improvements in these levels, compared with 47.8% in the placebo group. Researchers did not run a p-value in this endpoint.
Obesity has proved a challenging field to treat for years, and not just with drugs. Typical weight management strategies are often not enough to achieve full control, and those who follow with bariatric surgery to alter the digestive tract end up regaining weight more often than not.
That thesis appeared to be confirmed again in this trial, Kushner said, as everyone in the study participated in a diet and exercise program, regardless of whether they received semaglutide.
Some concerns remain over the drug’s safety, per a NEJM editorial published alongside the data. Though similar levels of side effects were seen in both groups, 89.7% in the drug arm and 86.4% in control, there was a higher rate of gastrointestinal events among those taking semaglutide — 74.2% vs. 47.9%.
Most of these fell into the mild or moderate categories, but serious gastrointestinal disorders accounted for the difference in total severe adverse event rates, the study authors said. Serious adverse events were reported in 9.8% and 6.4% of semaglutide and placebo participants, respectively, with 1.4% of participants on semaglutide reporting a severe GI event and 0% in the placebo group.
The trial population also did not prove representative of the US population as a whole, with most participants being women (74.1%) and White (75.1%). Overall, however, the results proved to be a significant step in the right direction, the author wrote.
The GLP-1 drug has already reaped billions for Novo Nordisk, taking in $1.64 billion in 2019 and $1.5 billion in the first half of 2020. In addition to diabetes, the company also has received breakthrough therapy designation for semaglutide in NASH, another area filled with speed bumps.
MOSCOW—Russia’s homegrown Sputnik V vaccine showed high levels of efficacy and safety in a peer-reviewed study released Tuesday, a potential boost for the Kremlin’s aim to promote the Covid-19 shot abroad and curb the pandemic at home.
The findings, from a preliminary analysis of a large-scale clinical trial published in the British medical journal the Lancet, demonstrated that the two-shot vaccine was 91.6% effective against symptomatic Covid-19 and offered complete protection against severe cases. There were no serious side effects, the paper said. The vaccine was also found to be similarly safe and effective in elderly people.
The study could be a significant milestone for Moscow in the global vaccination race, potentially offering President
Vladimir Putin’s
government geopolitical clout in the developing world and the chance to tap into the lucrative global vaccine market. Russia—the world’s fourth worst-hit country with nearly four million cases—has also banked on Sputnik V to avoid new costly lockdowns as authorities plan to vaccinate 60% of the domestic population by the end of the year.
The shot, which was approved by Russian authorities in August before undergoing large-scale clinical trials, has stirred questions in light of its fast-tracked development and lack of published trial data. So far, Sputnik V has been administered to more than two million people world-wide, including in Argentina, Serbia and Algeria, according to Russian authorities.
The Sputnik V Vaccine
Type: Two-dose viral vector vaccine
Efficacy: 91.6% (91.8% among people older than 60 years)
Price: Less than $10 a shot
Storage and transportation temperature: 36º-46ºF
Approved for use in: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Guinea, Tunisia and Armenia
Sources: The Lancet, Russian Direct Investment Fund
Tuesday’s results could help clear doubts surrounding the Russian shot.
“The development of the Sputnik V vaccine has been criticized for unseemly haste, corner cutting, and an absence of transparency,” virology professors Ian Jones at the U.K.’s University of Reading and Polly Roy at the London School of Hygiene & Tropical Medicine wrote in the Lancet. “But the outcome reported here is clear and the scientific principle of vaccination demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19.”
Alexander Gintsburg,
the head of the vaccine’s developer, the Moscow-based Gamaleya Institute, said that the data demonstrates Sputnik V’s safety and high efficacy against the virus.
This “is a great success in the global battle against the Covid-19 pandemic,” he said.
Sputnik V’s efficacy rate compares to vaccines developed by
Moderna Inc.
and
Pfizer Inc.
and its German partner
BioNTech SE,
which are around 95% effective.
The Lancet study didn’t address the shot’s usefulness against new variants of the virus, amid some early evidence suggesting strains may prove resistant to current vaccines. Russian officials said on Tuesday that they are continuously testing Sputnik V against new variants and they expect the shot to achieve the same level of efficacy. They also expect it to provide long-term immunity of as long as two years, based on early experimental evidence.
The results published on Tuesday were based on an interim analysis of a Phase 3 trial of nearly 20,000 participants, three-quarters of whom received the vaccine while the rest received a placebo. The analysis was based on a total of 78 confirmed Covid-19 cases, 62 of which were identified in the placebo group and 16 in the vaccine group. The clinical trial, totaling 40,000 volunteers, is ongoing.
Researchers found that the Covid-19 vaccine didn’t produce serious adverse reactions, the Lancet paper said. Most side effects included flulike symptoms, pain at the injection site and headaches.
Among the elderly, the vaccine was well tolerated and demonstrated an efficacy of 91.8%, based on a group of 2,144 volunteers older than 60, the paper said.
Like other Covid-19 vaccines, including ones developed by
Johnson & Johnson
and
AstraZeneca
PLC and Oxford University, Sputnik V uses a so-called viral vector approach. It introduces a genetically altered form of a harmless virus, known as the adenovirus, to serve as a vehicle—or vector—for a fragment of genetic material from the coronavirus.
As wealthier countries buy up supplies of Western drugmakers’ Covid-19 vaccines that are still in development, China and Russia are offering their fast-tracked shots to poorer nations. Here’s what they’re hoping to get in return. Illustration: Ksenia Shaikhutdinova
Each of the vaccine’s two shots is based on a different adenovirus vector, which Russian scientists say achieves a stronger immune response. Sputnik V has simpler logistics requirements compared with some of its peers, with a storage and transportation temperature of between 36 and 46 degrees Fahrenheit. The Pfizer vaccine must be kept at minus 94 degrees Fahrenheit before thawing.
With Sputnik V—a reference to the satellite the Soviet Union launched into orbit ahead of the U.S. in the Cold War space race—Russia could gain clout with some countries, analysts say, as well as participate in a global coronavirus vaccine market estimated by Russian officials at $100 billion annually.
Competing on price, Russia is selling the vaccine at less than $10 a dose, lower than Pfizer and Moderna, and is targeting up to 30% market share among Covid-19 shots in the countries buying Sputnik, according to Russian officials.
AstraZeneca has said that it would test whether a combination of its Covid-19 vaccine, which has shown to be between 62% and 90% effective depending on dosage, and Sputnik V can boost efficacy. Clinical trials for a combined shot are expected to start soon in Azerbaijan, the United Arab Emirates and other countries.
Some 15 countries outside Russia have already authorized Sputnik V, and Moscow has received orders or expressions of interest for 2.4 billion doses, including from Brazil, Mexico and India. In a bid to accelerate the global rollout, Russia will also offer a one-dose vaccine, dubbed Sputnik Light, which Russian authorities say would be between 73% and 85% effective.
To produce its vaccine, Russia relies on a global supply chain, including manufacturing hubs in Brazil, South Korea, India and China. Russia has also mounted an aggressive public-relations campaign abroad, including posting weekly video updates in English and maintaining a Twitter account for Sputnik V.
Sputnik V hasn’t been approved by Western health authorities or received authorization from the World Health Organization, which many developing countries rely on for vetting vaccines. Russia is in talks with the European Medicines Agency about approving the shot in the European Union and has applied for WHO authorization.
In Iran, health-care professionals and lawmakers criticized the government’s announcement that it would import Sputnik V, saying that the vaccine had not been approved by international bodies and that the purchase was politically motivated. Government officials said on Tuesday that Tehran would buy up to 1.5 million doses, with the first batch arriving as early as Saturday.
The domestic rollout has also faced challenges, including production delays and a skeptical populace.
Authorities have recently said that manufacturing is now being ramped up following initial equipment problems. They now expect to produce 11 million doses this month, up from seven million in January.
Around 46% of Russians said they would get a vaccine in a January survey by British polling firm Ipsos MORI, up 5 percentage points compared with December. Still, Russians were among the most reluctant to get inoculated globally, compared with 55% in France, 63% in the U.S. and 86% in the U.K.
Russia doesn’t publish daily vaccination rates, but regional data shows that at least 1.3 million Russians have received a dose so far.
Irina Levashova, a kindergarten teacher in Romodanovo, a small town some 400 miles southeast of Moscow, received her second shot last month along with her husband.
“I have many acquaintances who have been ill or even died from this disease, so I wanted to protect myself and my family,” Ms. Levashova, 58, said, adding that she didn’t experience any major side effects. “As soon as they started talking about vaccinations, I immediately told myself that me and my family would do it.”
—Valentina Ochirova contributed to this article
Write to Georgi Kantchev at georgi.kantchev@wsj.com
Scientists in California believe there is a homegrown coronavirus strain in the state that could be responsible for the dramatic rise in cases, a report said on Sunday.
Two separate research groups have discovered the apparent California strain while looking for the new variant that is believed to have come from the United Kingdom, according to the Los Angeles Times.
The supposed California strain is in the same “family tree” as the U.K. strain and could be behind the state’s spread over the past few months, the paper said.
One of the labs that discovered the strain, Cedars-Sinai Medical Center in Los Angeles said that it amounted to 24 percent of about 4,500 viral samples gathered throughout California in the last weeks of 2020.
Another analysis found that 25 percent of 332 samples taken in Northern California were of the new strain.
“There was a homegrown variant under our noses,” Dr. Charles Chiu, a laboratory medicine specialist at University of California, San Francisco, told the newspaper.
Chiu said that they only found the strain when searching for the UK variant.
Dr. Eric Vail, a pathologist at Cedars Sinai, said the strain could be responsible for doubling the state’s total death toll in the space of less than three months.
“It probably helped to accelerate the number of cases around the holiday season,” Vail said.
“But human behavior is the predominant factor in the spread of a virus, and the fact that it happened when the weather became colder and in the midst of the holidays when people gather is not an accident.”
Oregon officials on Saturday announced the state’s second known case of the contagious strain of the coronavirus that rapidly swept through the United Kingdom.
The Oregon Health Authority said it was notified Friday that someone in Yamhill County tested positive for the variant COVID-19 strain, which is known as B.1.1.7. The person has no known travel history, officials said.
Public health officials are investigating the person’s possible sources of infection.
A University of Portland employee last week became the first Oregonian identified with the new, more contagious strain of coronavirus.
Federal officials say the strain is far more transmissible than the standard coronavirus and will likely make up a bulk of U.S. infections by March.
Vaccines approved for the coronavirus are thought to work just as effectively against the new strain.
The Centers for Disease Control and Prevention reported 195 known cases of the variant strain nationwide Friday. That figure does not include Oregon’s second case.
— The Oregonian/OregonLive
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