PleoPharma’s CAN-002 Study of PP-01, a potential treatment for Cannabis Withdrawal Syndrome in Cannabis Use Disorder patients, shows encouraging Phase 2b results.

PHOENIXVILLE, Pa., June 19, 2025 — PleoPharma, Inc., a private company concentrating on health concerns linked to cannabis, has announced the presentation of data from its Phase 2b multi-center, randomized, double-blind, multi-dose, placebo-controlled clinical trial. The trial investigated PP-01, a treatment for Cannabis Withdrawal Syndrome (CWS) in individuals with Cannabis Use Disorder (CUD), using varying dosages. The presentation occurred at the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, LA.

PleoPharma, Inc. presented a poster titled “Predictors of Cannabis Abstinence in a Clinical Trial” on June 17, 2025, and an oral presentation titled “PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use” on June 18, 2025, using data from their Phase 2b study. This study assessed the safety and efficacy of PP-01, a once-daily oral investigational drug with a dual mechanism, containing tapering doses of nabilone and gabapentin, to alleviate cannabis withdrawal symptoms in participants with moderate to severe CUD. Adult participants in the CAN-002 Study seeking treatment reported using an average of 4.6 grams of cannabis per day at the start of the study, with an average age of first use of approximately 16.5 years (ranging from 7 to 46). Based on DSM-5 criteria, 84% had severe CUD and 16% had moderate CUD.

PP-01 significantly lowered Cannabis Withdrawal Scores compared to the placebo (P value < 0.02). A secondary outcome measure looked at cannabis abstinence, with PP-01 showing a 5-fold increase in abstinence two weeks after treatment compared to the placebo. The data also indicated that reducing cannabis withdrawal symptoms during the first week of treatment predicted abstinence. PP-01 was well-received. The most frequent side effects were minor and included headaches, sleepiness, tiredness, nausea, and dizziness. There were no significant negative effects.

“We are pleased to be developing PP-01, which has been granted Fast Track designation by the FDA, and could be the first FDA-approved drug to assist people with CWS and CUD, a rapidly growing patient group in need of therapy. We are currently getting PP-01 ready for Phase 3,” said Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research.

About cannabis withdrawal/cannabis use disorder
The US Government reported that in 2023, approximately 19.2 million Americans had CUD, with 1.64 million receiving treatment (about 500,000 inpatient, and about 1.1 million outpatient). The number of people seeking treatment for cannabis-related health issues has increased by an average of 28% per year from 2018 to 2023. Individuals with CUD frequently experience substantial withdrawal symptoms, known as CWS, which can make it very difficult to reduce or stop using cannabis. There are currently no FDA-approved drugs for treating CWS or CUD.

About PleoPharma, Inc.
PleoPharma, Inc. is a clinical-stage development company focused on neuropsychiatry and addiction, with its primary asset, PP-01, being developed as the first FDA-approved treatment for CWS in individuals with CUD.

The PleoPharma team is comprised of a top-tier management team and board of directors with a track record of numerous high-value exits, over 50 global product approvals, and more than 100 INDs.

For further details on PleoPharma, please visit or contact Dawn Halkuff, Head of Investor Relations, at .

This release contains ‘forward-looking statements’ regarding PleoPharma, Inc.’s operations. Actual results may differ from expectations, estimates, and projections, so you should not rely on these statements as predictions. All statements other than historical facts are forward-looking statements reflecting PleoPharma management’s current beliefs and expectations. These statements involve significant risks and uncertainties that could cause actual results to differ materially. PleoPharma disclaims any obligation to update or revise forward-looking statements to reflect changes in expectations, events, conditions, or circumstances.

SOURCE PleoPharma, Inc

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