Several experimental therapies being tested as treatments for patients who are severely ill with COVID-19 aim to reduce reliance on mechanical ventilators, which are in short supply in some American hospitals.
Among major drugmakers, this includes an experimental Eli Lilly & Co.’s LLY, +1.65% drug, Gilead Sciences Inc.’s GILD, +9.73% remdesivir, Regeneron Pharmaceuticals REGN, +5.34% and Sanofi’s SNY, +3.51% Kevzara, and Roche Holding AG’s ROG, +1.85% Actemra, all of which have said that reducing the need for mechanical ventilation is a primary or secondary endpoint in current or coming clinical trials in the U.S. (Kevzara and Actemra were previously approved by the Food and Drug Administration (FDA) as treatments for rheumatoid arthritis, while the Lilly drug and remdesivir are still considered experimental therapies.)
“Removal from mechanical ventilation is an important indicator that the patient’s lungs have improved, and that their pneumonia is resolving,” said Dr. Mark Eisner, an executive at Roche subsidiary Genentech who is overseeing the Actemra trial, in an email to MarketWatch.
It is a common endpoint for clinical trials testing treatments for people with severe influenza, acute lung injury or acute respiratory distress syndrome (ARDS), disorders that can occur in patients infected with respiratory viruses including the coronavirus that can make it difficult to breath on their own.
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Some smaller preclinical life sciences companies including Bellerophon Therapeutics Inc. BLPH, +4.87%, Beyond Air Inc. XAIR, -3.94% and the privately held CalciMedica Inc. are also evaluating ventilator need as they design clinical trials for COVID-19 therapies.
In the most severe cases of the disease caused by the virus, which has sickened more than 600,000 Americans and killed at least 33,000 people in the U.S., many patients struggle with respiratory issues requiring ventilation. In Italy, between 10% and 25% of hospitalized patients needed ventilation, according to a March 23 perspective in The New England Journal of Medicine. “Unlike decisions regarding other forms of life-sustaining treatment, the decision about initiating or terminating mechanical ventilation is often truly a life-or-death choice,” the authors of the perspective wrote.
At the same time, there has been an increasingly politicized debate about access and availability of ventilators in the U.S. The FDA on March 27 issued an emergency use authorization allowing certain ventilators to be “hacked” and used for multiple patients instead of one in instances where the devices are in short supply.
It’s no surprise then that the life sciences companies testing therapies or medical devices for the treatment of severely ill COVID-19 patients would make reducing the need for mechanical ventilation an endpoint in their clinical studies.
Lilly, which announced April 10 that it plans to put LY3127804 into a Phase 2 clinical study, is testing whether the investigational therapy can reduce the need for mechanical ventilation in severely ill COVID-19 patients. It’s also examining whether that therapy can limit the progression to ARDS.
The closely watched study evaluating Gilead’s remdesivir in severely ill patients was updated this month to allow patients who are on mechanical ventilation to participate in the Phase 3 clinical trial. “Previously, this trial excluded patients who required mechanical ventilation,” Evercore ISI’s Umer Raffat wrote in a note on April 8. “Now, a ‘Part B’ has been added to investigate patients who do require a fair amount of mechanical ventilation.”
Bellerophon’s Inopulse drug-delivery system, which dispenses nitric oxide, is currently waiting on the FDA to move forward with a clinical trial testing its device in COVID-19 patients. Past studies showed that nitric oxide helped get patients with severe acute respiratory syndrome (SARS) off ventilators, back in 2004.
“It is very reasonable to treat Covid-19 patients early on, before them needing ventilation support, with the goal of improving the oxygenation and preventing them from progressing to more intensive therapy including mechanical ventilation,” Dr. Hunter Gillies, the company’s chief medical officer, said by email. “This is important as it would free up ICU beds and mechanical ventilators for the most sick patients.”
Maxim Group’s Jason McCarthy talked up the potential value of the device, telling investors in a March 30 note that the Inopulse “may be able to reduce the need for ventilation and reduce the progression of the disease to severe, which would substantially reduce the impact on health care resources.” The company’s stock has soared 136.9% year-to-date.
Since the start of 2020, the Health Care Select Sector SPDR Fund XLV, +2.07% is down 3.1%, while the SPDR S&P Biotech Exchange-Traded Fund XBI, +5.50% has dropped 8.8% and the S&P 500 index SPX, +2.67% has lost 12.1%.
Originally Published on MarketWatch
