By Nancy Lapid
Hello Health Rounds readers! Today we report on a promising new drug that may help treat a serious lung condition considered one of the great unmet medical needs. We also report on an experimental triple threat respiratory disease vaccine in early development, and a potential addition to the pain management portfolio.
New drug shows promise in often-fatal lung condition
Doctors may soon have a better option for managing an often-fatal lung condition called acute respiratory distress syndrome, a small trial of an experimental antibody drug suggests.
In ARDS, injuries or infections trigger an inflammatory cascade that results in fluid leaking into the lungs, causing oxygen levels in the blood to plummet.
An estimated 500,000 people a year are diagnosed with ARDS in the United States, and 40% of them die, the researchers who conducted the trial said in a statement.
“There are no FDA-approved therapies to give these patients, and given the unacceptable mortality and pervasiveness of the disease, ARDS treatment remains one of the greatest unmet needs in medicine,” study leader Dr. Joe G.N. Garcia of the University of Florida Scripps Research Institute said in a statement.
In the proof-of-concept U.S. study, 15 patients were randomly assigned to receive the monoclonal antibody called ALT-100 being developed by Aqualung Therapeutics with help from National Institutes of Health grants, or a placebo.
ALT-100 targets an important regulator of inflammation called NAMPT.
Over a period of 28 days, the ALT-100 group needed mechanical ventilation to help with breathing an average of seven days, compared to 14 days for the placebo group.
The ALT-100 group also had lower levels of inflammatory markers in their blood and fewer cases of organ failure, which is the main cause of ARDS fatalities, according to the report published in the American Journal of Respiratory and Critical Care Medicine.
Safety issues were similar in the two groups, the researchers said.
“Even though we were only able to enroll 15 patients, the data we are getting is simply incredible,” said Garcia, Aqualung's founder and CEO.
Garcia said he is seeking funding for a larger clinical trial and has a green light from the U.S. Food and Drug Administration to study ALT-100 in patients with progressive pulmonary fibrosis, a buildup of scar tissue in the lungs.
Preventing three respiratory diseases with one shot
An experimental vaccine may be able to protect against a “tripledemic” of seasonal influenza, COVID-19 and respiratory syncytial virus, researchers say.
The three-in-one vaccine triggered protective immunity against all three respiratory diseases in mice, ferrets and cotton rats, they reported in Science Advances.
“The antibody responses were comparable to those produced by vaccines that target just a single virus, suggesting that combining the three vaccines into one shot did not weaken their effectiveness,” study leader Jonathan Lovell of the University of New York at Buffalo said in a statement.
The single-shot vaccine consists of tiny spherical nanoparticles made of cobalt and porphyrin with an outer shell of phospholipid, a combination known as CoPoP. Viral proteins attached to the nanoparticles help train the immune system to recognize and defend against the viruses.
Because it uses viral proteins rather than genetic instructions, the CoPoP approach differs from the most widely used COVID-19 vaccines, which rely on mRNA technology, the researchers pointed out.
They stress that additional studies are needed to determine whether subtle interactions among the different vaccine components could affect immune responses under different dosing conditions.
“We are hopeful that this platform could be expanded further to protect against an even wider range of respiratory viruses in the future,” Lovell said.
Melatonin may help ease chronic pain
Melatonin, commonly used for insomnia, may also help in managing chronic musculoskeletal pain, an analysis of past studies suggests.
The findings do not suggest melatonin should replace conventional painkillers. Instead, melatonin “may offer a safer additional option within a broader pain management plan,” study leader Kangchao Wu of the University of Sydney in Australia said in a statement.
Wu’s team analyzed 23 previously published randomized trials from around the world testing melatonin for reducing pain in more than 2,000 patients. On average, melatonin reduced pain by around nine points on a 0-100 scale, with the most rigorous trials showing reductions closer to 10 points, a similar magnitude to what is often achieved with widely used pain medications such as non-steroidal anti-inflammatory drugs like ibuprofen and aspirin or with acetaminophen.
The benefit was seen in patients with low back pain, osteoarthritis and fibromyalgia, but not in those recovering from painful surgeries, according to a report of the analysis in the journal Pain.
The researchers did not find evidence of a clear dose-response relationship, meaning no single “best” dose can be recommended from the current evidence.
"After consultation with a doctor," Wu said, melatonin "may be used as an adjunct to existing treatments, particularly for people who also experience sleep problems.”