Positive Phase 2b Results from the CAN-002 Study of PP-01, an investigational product intended to mitigate Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder

PHOENIXVILLE, Pa., June 19, 2025 /PRNewswire/ — PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 2b multicenter, randomized, double-blind, multi-dose, placebo-controlled clinical trial of titrating doses of PP-01 for the mitigation of Cannabis Withdrawal Syndrome (CWS) in participants with Cannabis Use Disorder (CUD) at the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, LA.

PleoPharma, Inc. presented both a poster presentation “Predictors of Cannabis Abstinence in a Clinical Trial” on June 17, 2025 and an oral presentation “PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use” on June 18, 2025 from their Phase 2b study data.  This study evaluated the safety and effectiveness of PP-01, a novel once daily, oral, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. Adult treatment-seeking participants in the CAN-002 Study reported average baseline cannabis use of 4.6 grams/day and mean age of first use ~16.5 years (range 7 to 46). By DSM-5 criteria, 84% had severe CUD and 16% had moderate CUD.

PP-01 significantly reduced Cannabis Withdrawal Scores compared to placebo (P value < 0.02). A secondary endpoint evaluated cannabis abstinence and PP-01 demonstrated 5-fold greater abstinence two weeks post-treatment compared to placebo.  Data also showed that reduction of cannabis withdrawal symptoms during the first week of treatment was predictive of abstinence. PP-01 was well tolerated. The most common adverse events were mild and included headache, somnolence, fatigue, nausea, and dizziness. There were no serious adverse events.

“We are excited to be developing PP-01, which was granted Fast Track designation by the FDA, and has the potential to be the first FDA approved product to help people suffering from CWS with CUD, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3”, stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research.

About cannabis withdrawal/cannabis use disorder
The US Government reported that in 2023 (samhsa.gov), ~19.2 million Americans had CUD 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 CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD.

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 CWS in people with CUD.

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.

For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at [email protected].

This release includes ‘forward-looking statements’ regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE PleoPharma, Inc