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Fast Track Designation highlights the potential of PP-01 to address a serious and unmet need for patients with Cannabis Use Disorder Phase 3 Preparations Underway PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder. "We are pleased that PP-01 has been granted Fast Track designation and are grateful to the FDA for recognizing the significance of cannabis withdrawal for the growing population with cannabis use disorder," said Ginger Constantine MD, CEO of PleoPharma. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier (FDA.gov). In addition, a drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling and priority reviews. About cannabis withdrawal/cannabis use disorder The US Government (SAMHSA) reported that in 2023, ~19.2 million Americans had cannabis use disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The reported number of individuals who received treatment for cannabis related health problems has grown by an average of 27% annually from 2018 to 2023 (samhsa.gov). People with cannabis use disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of either cannabis withdrawal syndrome or cannabis use disorder. "We recognize that many people do use cannabis without becoming dependent", said Ginger Constantine, "but as with alcohol, some may develop a dependence (use disorder) that may be sustained and worsened by withdrawal symptoms. Our mission is to provide a treatment option for those who want help discontinuing cannabis." About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering a Phase 3 clinical trial and has the potential to be the first-in-class treatment to mitigate the withdrawal syndrome experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended to be a once daily oral product with a rapid onset of action and an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis related health problems. 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 Inc., please visit 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pharmacodynamic Results from the CAN-001 Phase 1b Study of PP-01, an Investigational Product, intended to Mitigate Cannabis Withdrawal Syndrome PHOENIXVILLE, Pa., Nov. 18, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 1b Pharmacokinetic and Pharmacodynamic study of Cannabis Withdrawal Syndrome ("CWS") in participants with Cannabis Use Disorder ("CUD") at the annual meeting of the American Academy of Addiction Psychiatry (AAAP) in Naples, Fla. "We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01, a novel, 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. We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, 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. Participants in the CAN-001 Study reported using an average of 3.5 ± 2.2 grams/day of cannabis with a mean age of first use 14 years (range 6 to 22). By DSM-5 criteria, 64% had severe CUD and 36% had moderate CUD. Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). This effect was sustained through Day 5 (P values < 0.0009; all timepoints). Participants experienced fewer cravings, better sleep and were also less bothered by their withdrawal symptoms when treated with PP-01 than with placebo (P values < 0.007; all timepoints). PP-01 was well tolerated. There were no serious adverse events, and all adverse events in the PP-01 group were mild in severity. 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 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED