As the situation worsens, Gilead begins two, late-stage studies to test drug for coronavirus.
The coronavirus, or COVID-19, has infected more than 80,000 people in about three dozen countries since it was discovered in late December. More than 2,700 have died, most of them in mainland China. As of Friday (February 28, 2020), there were currently 60 confirmed cases in the US. Fears of a global pandemic are now widespread, but scientists at biotech and big pharma companies aren’t waiting for their governments to take the needed steps to contain and manage the worsening conditions.
Case in point: Gilead Sciences Inc. (Foster City CA) last week announced the initiation of two Phase 3 trials to evaluate the safety and efficacy of its experimental broad-spectrum antiviral remdesivir in adults diagnosed with COVID-19. According to the company, the studies will enroll roughly 1,000 patients at medical centers mainly across Asian countries, as well as other countries around the world with high numbers of diagnosed cases, beginning in March.
Specifically, one study will randomize approximately 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir administered intravenously, FirstWordPharma reports. The primary objective is to evaluate the effect of the drug, as measured by the normalization of fever and oxygen saturation, sustained for at least 24 hours through day 14. The second trial will randomize roughly 600 patients with moderate clinical manifestations of disease to receive five- or 10-day dosing regimens of remdesivir or standard-of-care alone. The main goal here will be to assess the drug’s effect as measured by the proportion of participants in each group discharged by day 14.
Gilead said initiation of the trials follows the FDA’s rapid review and acceptance of its investigational new drug filing for remdesivir. The news comes a day after the US National Institute of Allergy and Infectious Diseases said it launched a study evaluating remdesivir in hospitalized adults diagnosed as having COVID-19. The RNA polymerase inhibitor, which was initially developed for Ebola, is also being tested in two clinical trials in China, with results due in April.
Merdad Parsey, chief medical officer at Gilead, said the “primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time.”
Gilead closed the week off 34 cents at $69.36.
Medical Stock Spotlight
Fear over the economic fallout from the spreading coronavirus continued to rattle global markets Friday (February 28, 2020), sending US equities to a seventh straight loss and sparking demand for safe assets from Treasuries to the yen. The S&P 500 plunged more than 2% Friday and is now down almost 15% from its record. The index is headed for its worst week since 2008 and is mired in its longest slump in over three years. Federal Reserve Chairman Jerome Powell said the central bank is monitoring the virus and will act as appropriate, adding that the “fundamentals” of the economy remain strong. Bank of America strategists now expect the Fed to cut rates by 50 basis points at its March meeting.
Healthcare stocks saw their worst week in two decades. For insurers, a widespread coronavirus outbreak will almost certainly result in higher costs as Americans who get sick seek medical care. Last week’s market sell-off over coronavirus fears hit health insurance and hospital stocks especially hard. The S&P 500 Managed Health Care sector had its worst weekly loss since Feb. 2009, falling more than 15% for the week. For insurers, obviously, a widespread coronavirus outbreak will almost certainly result in higher costs as Americans who get sick seek medical care.
Shares of UnitedHealth Group Inc. snapped a six-session losing streak on Friday, but ended the week down nearly 17% from its historic high on Feb. 19. Shares of pharmacy and insurance giant CVS Health and Medicaid insurer Centene Corp. fell into bear market territory, down more than 23% from their highs, while hospital operator Tenet Healthcare fell 23% for the week.
But, as usual, there were a handful of really big gainers in the sector and a couple of massive clunkers. Here they are, starting with the upside group.
- Allied Healthcare Products Inc.(Nasdaq:AHPI) led advancing issues, skyrocketing 876% over the week to $24.00. That’s highly unusual since the spike for the St. Louis-based company doesn’t have a specific reason for the wild upward ride. In actuality, the company hasn’t issued any press releases or SEC filings as of late. Analysts say the gains have more to do with the company’s products in general. Allied makes several products, but what seems to have the market buzzing is its portfolio of respiratory health products. It may simply have to do with the Wuhan coronavirus (COVID-19), a form of upper respiratory illness. This means that in treating those with COVID-19, physicians will look for products that support positive respiratory health. Considering the respiratory health products created by Allied Healthcare Products, it only makes sense that as the coronavirus epidemic continues to spread, the company will see an increase in demand, ultimately generating increasing revenue and a push toward higher profits.
- Elsewhere, Co-Diagnostics Inc. (Nasdaq:CODX) soared 334% to $13.23 after announcing the completion of its technical submissions and receipt of European approval for its in vitro diagnostic test for the novel coronavirus, known as SARS-CoV-2. The Salt Lake City-based developer’s Logix Smart Coronavirus COVID-19 Test is now available to be exported from Utah to countries requiring the CE Mark, according to the company. “Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago,” CEO Dwight Egan said. The company also said it previously shipped research-use-only versions of the test to distributors in Italy and Germany to help familiarize local users with its functionality and sensitivity. The molecular diagnostic test searches for RNA linked to the coronavirus strain using a real-time RT-PCR kit aimed at conserved regions in the virus’s genome.
- And Vir Biotechnology Inc.(Nasdaq:VIR) more than doubled, surging 186% to $46.50 after the company announced a collaboration with WuXi Biologics. The pair will work together to develop antibodies to treat the novel coronavirus strain, SARS-CoV-2, that is spreading from China and causes the respiratory illness COVID-19. San Francisco-based Vir Biotechnology will be responsible for the design and development of antibodies that bind to spike proteins found on SARS-CoV-2. It will own commercial rights outside of China. WuXi will be responsible for developing cell lines that can manufacture the antibodies. It will own commercial rights in China. The company has previously announced the identification of two antibodies with activity against the novel strain of coronavirus. The idea is that the antibodies would bind to and neutralize the virus, disrupting replication and lessening the disease burden for those infected.
- But Aptorum Group Ltd. (Nasdaq:APM) plunged 58% to an historic low of $6.00 after the company announced the pricing of its $10 million direct offering. The Hong Kong-based biopharmaceutical company said that it is offering 1.35 million Class A ordinary shares and warrants at $7.40 each. Aptorum intends to use the proceeds from the offering towards the research and development of its therapeutic candidates, the expansion of its discovery and development pipeline of the Smart-ACTTM orphan diseases platform and general corporate purposes. Established in 2010, Aptorum develops and commercializes a variety of therapeutic and diagnostic technologies to treat unmet medical needs. The company focusses on therapeutic projects in orphan diseases, infectious diseases, metabolic diseases and other disease areas. Last month, Aptorum announced the commercialization of its dietary supplement for women undergoing menopause.
- And Menlo Therapeutics Inc.(Nasdaq:MNLO) plummeted 43% to $2.95 after the biopharmaceutical company said a mid-stage trial of a treatment for chronic pruritus, a form of skin itching, of unknown origin failed to meet its main goal. The trial involved 233 patients and sought to show a statistically significant reduction in pruritus in patients treated with the company’s serlopitant compared to placebo. “We conducted this trial in CPUO in the hope of offering the first-ever approved therapy for patients suffering from severe pruritus associated with this condition,” said Steve Basta, CEO of Menlo Therapeutics. “We were surprised to see a placebo response significantly larger than observed in our prior studies.” The Redwood City, CA-based company estimates that ~2 million Americans suffer from the condition. It is expecting Phase 3 trial results in March or April.
Drinking milk increases the risk of developing breast cancer?
After a review from top nutrition scientists that cautioned against drinking cow’s milk came another study with an additional warning: drinking milk increases the risk of developing breast cancer, say the researchers. But this finding comes from an observational study, and there may be confounders that are not accounted for, says an expert not involved with the study, according to Medscape.
The latest research was based on data from the long-running larger study called Adventist Health Study-2 (AHS-2), which is looking at diet and health among Seventh Day Adventists in North America. Past results from this study have suggested that Seventh Day Adventists have longer life spans and lower rates of some cancers, perhaps because of heathier lifestyles. The latest analysis suggests that milk raises breast cancer risk, and the more you drink the higher your risk may be.
“Consuming as little as 1/4 to 1/3 cup of dairy milk per day was associated with an increased risk of breast cancer of 30%,” first author Gary E. Fraser, MBChB, PhD, said in a press statement.
Fraser is affiliated with the School of Public Health at Loma Linda University, California.
“By drinking up to 1 cup per day, the associated risk went up to 50%, and for those drinking 2 to 3 cups per day, the risk increased further to 70% to 80%,” Fraser added.
The findings were published February 25 in the International Journal of Epidemiology.
“The AHS study is provocative, but it’s not enough to warrant a change in guidelines. The caution being espoused by the authors is not warranted given the observational nature of this study,” commented Don Dizon, MD, director of Women’s Cancers, Lifespan Cancer Institute at Brown University in Providence, RI.
He was not involved with the study and was approached by Medscape. Because of its observational design, the study cannot prove that cow’s milk causes breast cancer, Dizon emphasized.
“I’d want to see if the findings are replicated [by others]. Outside of a randomized trial of [cow’s] milk vs. no milk or even soy, and incident breast cancers, there will never be indisputable data,” he said.
“Probably the biggest point [about this study] is not to overinflate the data,” Dizon added.
He noted that the results were significant only for postmenopausal women and not for premenopausal women. Moreover, analyses showed significant associations only for hormone receptor-positive cancers.
In just four years, marijuana use grew by 75% among Americans aged 65 and older, according to a new study, and researchers expressed concern over a lack of information on the potential health implications. The increase was most pronounced in women, those with higher incomes and more education, according to a report published in JAMA Internal Medicine.
The findings continue a trend seen over the last decade, said the study’s lead author, Benjamin Han, an assistant professor of geriatric medicine and palliative care at the New York University School of Medicine.
“Consider that not even 10 years ago 0.4% of adults 65 and older said they had used marijuana in the past year, and now it’s 10 times that at 4%,” Han said.
The trend is concerning, Han said, because of the lack of research on the effects of cannabis on older people. Some prescription and even over-the-counter medicines, such as Benadryl, affect older people differently, he said. It was not known whether the trend is tied to marijuana becoming legally available in a growing number of US states, or if people had been using the drug for many years before turning 65.
Although researchers initially suspected medical issues might have driven the rise in marijuana use among seniors, most appeared to be in relatively good health, Han said. Researchers looked at four recent years of data from the National Survey on Drug Use and Health. Among 14,896 respondents to the nationally representative survey who were 65 or older, marijuana use increased from 2.4% to 4.2% from 2015 through 2018. In men, the percentage rose from 3.6% to 4.2%, while for women it jumped from 1.5% to 2.9%. Among college educated seniors, marijuana use over age 65 rose from 2.9% to 6.2%, and in those making $75,000 a year or more, from 2.4% to 5.5%.
The findings underscore the importance of monitoring marijuana use in this growing population, said Ziva Cooper, research director at the UCLA Cannabis Research Initiative, who was not involved with the study.
“Without these data, we wouldn’t know what was going on in this age group,” she said. “It’s the fastest growing one and it’s important to study.”
It also points to the need for additional research.