Pleopharma Reports Positive Phase 2b Data for Cannabis Withdrawal Treatment

PleoPharma, Inc., a privately held company dedicated to tackling health issues related to cannabis use, has announced promising results from its Phase 2b study of PP-01, its leading drug candidate aimed at easing Cannabis Withdrawal Syndrome. The study's success has paved the way for Phase 3 preparations, following an End of Phase 2 meeting with the FDA.

The Phase 2b study, designated CAN-002, was a randomized, double-blind, placebo-controlled trial involving 234 participants aged 18-55, all of whom were seeking to quit cannabis use. Conducted across 22 addiction centers in the United States, the study revealed that PP-01 significantly reduced cannabis withdrawal symptoms compared to a placebo. Notably, the highest dose of PP-01 delivered clinically meaningful results, achieving the primary endpoint with a p-value of 0.02. Importantly, the drug was well-tolerated and did not raise any safety concerns.

The company is now gearing up for Phase 3 trials, which will proceed in consultation with the FDA, following the constructive feedback received during the recent End of Phase 2 meeting.

The issue of cannabis withdrawal and Cannabis Use Disorder is becoming increasingly significant. According to a 2023 report by the US Government, approximately 19.2 million Americans were diagnosed with Cannabis Use Disorder, with about 1.64 million receiving treatment, either inpatient or outpatient. From 2018 to 2023, the number of individuals seeking treatment for cannabis-related health problems rose by an average of 28% annually. Despite the growing need, there are currently no FDA-approved medications for treating cannabis withdrawal syndrome or Cannabis Use Disorder.

Ginger Constantine, MD, CEO of PleoPharma, emphasized the potential impact of PP-01, stating, "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. 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."

PP-01 operates through a dual mechanism of action, targeting suppressed CB1 receptors and neurotransmitter dysregulation within the mesolimbic reward pathway. Designed as a once-daily oral product taken before bedtime, PP-01 aims to offer rapid and sustained relief from withdrawal symptoms while maintaining a strong safety and tolerability profile.

PleoPharma, Inc. is a clinical-stage development company specializing in the neuropsych and addiction sectors. Its primary asset, PP-01, is on track to become the first FDA-approved treatment for Cannabis Withdrawal Syndrome in individuals with Cannabis Use Disorder. The company boasts a world-class management team and board of directors with extensive experience, having achieved multiple high-value exits and over 50 worldwide product approvals, along with more than 100 Investigational New Drug (IND) applications.

This announcement marks a significant milestone for PleoPharma as it continues to advance PP-01 through the clinical trial phases, with the ultimate goal of addressing a critical unmet need in the treatment of cannabis-related health issues.

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