PHOENIXVILLE, PA — PleoPharma, Inc. has closed a $36 million Series B financing round to accelerate development of PP-01, its lead investigational therapy for Cannabis Withdrawal in patients with Cannabis Use Disorder (CUD). The company’s Phase 3 candidate is currently the only treatment in its class to receive Fast Track designation from the U.S. Food and Drug Administration.
The investment, led by SuperVision Partners LLC with participation from Castle Hill Capital Partners, will support PleoPharma’s late-stage clinical trials and regulatory initiatives.
“Cannabis addiction continues to accelerate, with over 20 million Americans affected and no FDA-approved treatment options available,” said Dr. Ginger Constantine, co-founder and CEO of PleoPharma. “We are grateful to partner with investors who share our mission to deliver first-in-class therapies for those struggling with cannabis addiction and withdrawal.”
According to 2024 data from the Substance Abuse and Mental Health Services Administration (SAMHSA), approximately 20.6 million Americans had cannabis use disorder, with treatment rates for cannabis-related issues rising by an average of 27% annually between 2018 and 2023.
PP-01 employs a dual mechanism of action designed to target suppressed CB1 receptors and correct neurotransmitter imbalances in the brain’s mesolimbic reward pathway. The once-daily oral medication aims to rapidly alleviate withdrawal symptoms while maintaining a strong safety and tolerability profile.
Dr. Constantine emphasized that while many people use cannabis without dependency, others face significant withdrawal challenges. “As with alcohol, some individuals develop dependence,” she said. “Our goal is to provide an effective treatment option for those who want help discontinuing cannabis.”
PleoPharma, a clinical-stage biotech firm specializing in neuropsychiatric and addiction therapies, is led by a team with more than 50 global product approvals, over 100 Investigational New Drug applications, and a track record of multiple high-value exits.
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