Kratom grows in several Asian countries and has been traditionally used by local communities as a natural home remedy for pain, depression and addiction. Now, several psychedelics companies are developing substances based on this plant and several US states have already enacted legislation that regulates its production, distribution and sale.
One of the companies working with kratom is atai Life Sciences (NASDAQ:ATAI), which has announced that its subsidiary and Columbia University spinout, Kures, obtained positive results on its Phase 1 clinical trial of proprietary KUR-101 for the treatment of Opioid Use Disorder (OUD) and acute pain.
KUR-101 is a deuterated derivative of mitragynine, the major alkaloid in kratom and a relatively low-potency mu-opioid receptor (MOR) agonist. The drug, semi-synthetically produced, is designed to improve the safety profile and potential effectiveness of mitragynine.
According to the CDC, the U.S. saw an approximate 30% increase in drug overdose deaths in 2020 with nearly 75% opioid-related. Of all patients undergoing OUD therapy with three FDA-approved therapeutics, there is 75% relapse within one year of treatment, said atai’s CEO Florian Brand.
Pharmaceutical medications approved for OUD such as buprenorphine, methadone and naltrexone have proven to have limited efficacy for many patients, in addition to inherent risks of abuse. By contrast, KUR-101’s pharmacological profile might be safer for chronic use, as mitragynine would help reduce dosing requirements.
Preclinical studies have already shown atai’s proprietary drug produces analgesic effects without significant respiratory depression. Clinical-stage initial results have shown that a single-ascending oral dose of the drug produces pain relief with virtually no effects on breathing.
Topline results of this clinical study, including the comparison of a single dose of KUR-101 to a single dose of oxycodone or placebo, are expected by the end of 2022.
Photo by Su San Lee on Unsplash
