Atai Life Sciences (Nasdaq:ATAI) announced inconclusive data regarding the effects of the kratom-derived compound KUR-101 on respiration in a Phase 1 study.
The company’s stock was down about 9% in mid-day trading, trading at $2.77.
The drug candidate yielded dose-dependent analgesic effects in Part 1 of the study, which assessed the safety and efficacy of various dose levels of KUR-101 (10, 20, 40, 60 and 90 mg).
Data from Part 2 of the Phase 1 study found that a 90 mg dose of KUR-101 yielded analgesic effects in the cold-pressor test and thermal testing, but oxycodone was superior at relieving pain. In that study, KUR-101 and oxycodone had a similar effect on respiration to placebo, preventing a definitive assessment of KUR-101’s impact on respiration.
“As the data comparing the respiratory effects of KUR-101 to both oxycodone and placebo are inconclusive at this stage, additional research will be needed to further characterize the therapeutic potential of KUR-101,” said Florian Brand, CEO and co-founder of Berlin-headquartered Atai, in a press release.
Opioids can be dangerous, given their potential to interfere with normal respiration and cardiovascular activity.
Mitragynine, a kratom derivative acting as a partial mu-opioid receptor agonist, is the inspiration for KUR-101. Prior animal studies indicate that mitragynine had limited respiratory depressant effects.
KUR-101, a deuterated form of mitragynine, did not have a clinically significant impact on respiration in Part 1 of the study at any of the five dose levels investigated.
In October, Atai Life Sciences (Nasdaq:ATAI) released positive initial results from the Phase 1 clinical study of KUR-101.
Atai subsidiary Kures is developing the drug candidate. We interviewed the subsidiary’s CEO in October.
The FDA has warned against using kratom, a popular supplement for pain management. In addition, the federal government has seized multiple shipments of raw kratom and related supplements since 2014.
In 2016, the DEA announced a plan to temporarily classify mitragynine and 7-HMG Schedule I drugs but eventually changed its mind.