PleoPharma Raises $36M Series B to Advance First-in-Class Cannabis Withdrawal Treatment to Phase 3
核心洞察
PleoPharma (搜索) secured $36 million in Series B funding to advance PP-01, its investigational treatment for cannabis use disorder (搜索) and withdrawal syndrome, into Phase 3 trials.
The once-daily oral therapy targets over 20 million Americans with cannabis use disorder (搜索), representing the first potential FDA-approved treatment for this indication.
PP-01 demonstrated statistically significant reductions in cannabis withdrawal scores (P < 0.02) and five-fold greater abstinence rates in Phase 2b trials.
Phoenixville-based PleoPharma (搜索) has closed a $36 million Series B financing round to advance PP-01, its lead investigational therapy for cannabis use disorder (搜索) (CUD) and cannabis withdrawal syndrome (搜索) (CWS), into Phase 3 trials. The funding round was led by SuperVision Partners LLC (搜索) with participation from Castle Hill Capital Partners (搜索) and existing Series A investors.
The investment addresses a significant unmet medical need, as more than 20 million Americans are estimated to have cannabis use disorder (搜索) with no FDA-approved treatment options currently available. According to 2024 data from the Substance Abuse and Mental Health Services Administration (SAMHSA (搜索)), 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.
Dual Mechanism Approach Shows Promise
PP-01 is a once-daily oral medication designed with a dual mechanism of action that targets suppressed CB1 receptors (搜索) and addresses neurotransmitter dysregulation in the mesolimbic reward pathway (搜索). The therapy aims to reduce withdrawal symptoms and support abstinence in patients seeking to discontinue cannabis use while maintaining a strong safety and tolerability profile.
The investigational treatment demonstrated encouraging results in earlier clinical studies. In the Phase 2b CAN-002 trial, PleoPharma (搜索) reported statistically significant reductions in cannabis-withdrawal scores (P < 0.02) and a five-fold greater abstinence rate two weeks post-treatment compared with placebo. The asset was well-tolerated, with no serious adverse events reported.
FDA Recognition and Regulatory Progress
The FDA granted Fast Track designation to PP-01 in February 2025, helping expedite development and review processes. This designation signals recognition of the unmet need and potential clinical value of the therapy. PleoPharma (搜索) has also strengthened its intellectual property position with U.S. patents related to treatment methods for cannabis withdrawal syndrome (搜索).
"Recent government data from SAMHSA (搜索) reported that cannabis addiction continues to accelerate with over 20 million people reported to have Cannabis Use Disorder (搜索) in the US, an underserved population with no effective or FDA approved solution," said co-founder and CEO Dr. Ginger Constantine. "We are grateful to have the partnership of this incredible group of new and existing investors who share our commitment to deliver first in class treatments for those with cannabis addiction and withdrawal."
Clinical Development Strategy
The Series B proceeds will specifically support PleoPharma (搜索)'s Phase 3 program for patients diagnosed with CUD. The company's Phase 3 candidate is currently the only treatment in its class to receive Fast Track designation from the FDA, positioning it as a potential first-in-class therapy for cannabis withdrawal.
Dr. Constantine emphasized the therapeutic need, noting 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 (搜索) is led by a management team with more than 50 global product approvals, over 100 Investigational New Drug applications, and a track record of multiple high-value exits in the neuropsychiatric and addiction therapy space.