PLEOPHARMA, INC. REPORTS POSITIVE PHASE 2b CLINICAL TRIAL DATA FOR MITIGATION OF CANNABIS WITHDRAWAL: A POTENTIAL FIRST IN CLASS TREATMENT

Phase 2b Study for PP-01 Met Its Primary Endpoint

End of Phase 2 Meeting with FDA Completed

Phase 3 Preparations Underway

PHOENIXVILLE, Pa., Sept. 5, 2024 /PRNewswire/ — PleoPharma, Inc., a privately held company focused on cannabis related health issues, announced today Phase 2b study results for its lead drug candidate, PP-01, an investigational product intended for the mitigation of Cannabis Withdrawal Syndrome.

Phase 2b Study (CAN-002)

CAN-002 was a randomized, double-blind, placebo-controlled study with 234 participants between ages 18-55, seeking to discontinue cannabis, at 22 US addiction centers. Participants in the study demonstrated statistically significant reductions in cannabis withdrawal symptoms with PP-01 vs. Placebo. A dose response was observed with the highest dose providing mitigation of withdrawal symptoms with clinically meaningful results (primary endpoint p=0.02). PP-01 was well tolerated and without a safety signal.

Phase 3 planning continues in conjunction with FDA input following a recently completed End of Phase 2 FDA meeting.

About cannabis withdrawal/cannabis use disorder

The US Government reported that in 2023 (samhsa.gov), ~19.2 million Americans had Cannabis Use Disorder 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 Cannabis Use Disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder.

“The completed Phase 1 and Phase 2 studies demonstrate that PP-01 has the potential to help those who suffer from cannabis withdrawal when attempting to discontinue cannabis,” said Ginger Constantine, MD, CEO PleoPharma.” We recognize that many people do use cannabis responsibly but, as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis.”

About PP-01

PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway.

PP-01 is an investigational product entering Phase 3 that is being developed to mitigate symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile.

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 Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder.

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.

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