PHOENIXVILLE, Pa. — PleoPharma Inc., a privately held company focused on cannabis related health issues, announced Phase 2b study results for its lead drug candidate, PP-01, an investigational product intended for the mitigation of Cannabis Withdrawal Syndrome.
Phase 2b Study (CAN-002)
CAN-002 was a randomized, double-blind, placebo-controlled study with 234 participants between ages 18-55, seeking to discontinue cannabis, at 22 US addiction centers. Participants in the study demonstrated statistically significant reductions in cannabis withdrawal symptoms with PP-01 vs. Placebo. A dose response was observed with the highest dose providing mitigation of withdrawal symptoms with clinically meaningful results (primary endpoint p=0.02). PP-01 was well tolerated and without a safety signal.
Phase 3 planning continues in conjunction with FDA input following a recently completed End of Phase 2 FDA meeting.
About cannabis withdrawal/cannabis use disorder
The US Government reported that in 2023, ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder.
“The completed Phase 1 and Phase 2 studies demonstrate that PP-01 has the potential to help those who suffer from cannabis withdrawal when attempting to discontinue cannabis,” said Ginger Constantine, MD, CEO PleoPharma.” We recognize that many people do use cannabis responsibly but, as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis.”
About PP-01
PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway.
PP-01 is an investigational product entering Phase 3 that is being developed to mitigate symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile.
About PleoPharma Inc.
PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder.
The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs.
