shutterstock 18223567Galleon Pharmaceuticals released outcomes in a clinical proof-of-concept study evaluating the ability of its lead investigational drug, GAL-021, to successfully regulate respiratory drive, a key requirement to prevent respiratory complications in high-risk surgical patients.

This is the first time a drug has been shown to regulate and protect respiratory drive from drug-induced respiratory depression, according to the company. In this study, intravenous GAL-021 was able to reverse respiratory depression under challenging conditions including high doses of opioids and elevated carbon dioxide levels, which can be particularly problematic for post-surgical and sleep apnea patients. The company is actively seeking funding to advance this promising candidate into a broad Phase II program.

“These findings are exciting and represent an important advance in the treatment of respiratory depression,” said Albert Dahan, MD, PhD, principal study investigator and professor of anesthesiology at the Leiden University Medical Center, Netherlands. “For the first time, we have shown that a drug can reverse opioid-induced respiratory depression without affecting analgesia. This has the potential to be a major advance for physicians and hospitals that care for high-risk surgical patients, such as those with sleep apnea, obesity, or recent opioid use.”

In the double-blinded, placebo-controlled crossover study, 12 people with both normal and elevated carbon dioxide levels were given alfentanil, a potent opioid analgesic drug commonly used during surgery. Then two dose-levels of alfentanil and two dose-levels of GAL-021 were administered. In this study, GAL-021 successfully protected against the opioid-induced respiratory depression while not affecting analgesia. The dose-dependent protective effect of GAL-021 was statistically and clinically significant at both low and high doses of alfentanil. GAL-021 was well-tolerated with side effects that did not differ from placebo.

“Impaired respiratory drive worsens sleep apnea and Galleon’s research into drug candidates to treat this condition is very exciting,” said Sigrid Veasey, MD, associate professor of medicine at the University of Pennsylvania’s Center for Sleep and Circadian Neurobiology. “The demonstration that Galleon’s first clinical candidate can regulate respiratory drive is an important milestone for the oral drug candidates that may have utility for sleep apnea patients seeking an alternative to mask-based positive-pressure machines.”

Galleon’s drugs work through a novel mechanism of action allowing creation of both oral and intravenous products for a variety of clinical uses including post-surgical care of high-risk patients, chronic pain patients using opioids, and sleep apnea.