A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms

This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).

开始日期2022-10-27

申办/合作机构

Pleopharma LLC

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项与 Gabapentin/Nabilone 相关的文献（医药）

2019-02-01·FEMS Microbiology Letters

Modification of T2 phage infectivity towardEscherichia coliO157:H7 via using CRISPR/Cas9

Article

作者: Tanji, Yasunori ; Yoshizaki, Kyohei ; Takao, Nobumasa ; Miyanaga, Kazuhiko ; Hoshiga, Fumiya

Phage therapy is getting considerable attention as a method for prophylaxis of food poisoning caused by Escherichia coli O157:H7, an important pathogen causing life-threatening bloody diarrhea. Despite previous studies have shown the feasibility of phage therapy to E. coli O157:H7, promising results have not been obtained in vivo yet. A major drawback of phage therapy is that bacteriophages have high specificity and cannot infect all the sub-strains of a particular pathogenic strain. To overcome this hurdle, we thought to establish a way to artificially expand the host-range of E. coli O157:H7-specific phages. To develop a proof-of-concept for this method, we focused on T2 phage, which cannot infect E. coli O157:H7 strains, and PP01 phage, which displays broad infectivity to them, and attempted to make T2 phage able to infect E. coli O157:H7 as efficiently as PP01. We report the trials of T2 genome editing using the CRISPR/Cas9 system and the modification of both long and short tail fibers of this phage based on comparison with PP01. The resultant recombinant showed the adsorption rate comparable to PP01. Thus, we provided the evidence that the short tail fiber of PP01 plays an important role in adsorption to E. coli O157:H7.

2005-01-01·Journal of Biotechnology3区 · 工程技术

Alteration of tail fiber protein gp38 enables T2 phage to infect Escherichia coli O157:H7

3区 · 工程技术

Article

作者: Michiharu Abe ; Yasunori Tanji ; Masatoshi Yoichi ; Kazuhiko Miyanaga ; Hajime Unno

Artificial control of phage specificity may contribute to practical applications, such as the therapeutic use of phages and the detection of bacteria by their specific phages. To change the specificity of phage infection, gene products (gp) 37 and 38, expressed at the tip of the long tail fiber of T2 phage, were exchanged with those of PP01 phage, an Escherichia coli O157:H7 specific phage. Homologous recombination between the T2 phage genome and a plasmid encoding the region around genes 37-38 of PP01 occurred in transformant E. coli K12 cells. The recombinant T2 phage, named T2ppD1, carried PP01 gp37 and 38 and infected the heterogeneous host cell E. coli O157:H7 and related species. On the other hand, T2ppD1 could not infect E. coli K12, the original host of T2, or its derivatives. The host range of T2ppD1 was the same as that of PP01. Infection of T2ppD1 produced turbid plaques on a lawn of E. coli O157:H7 cells. The binding affinity of T2ppD1 to E. coli O157:H7 was weaker than that of PP01. The adsorption rate constant (ka) of T2ppD1 (0.17 x 10(-9)(ml CFU(-1) min(-1)) was almost 1/6 that of PP01 (1.10 x 10(-9)(ml CFU(-1) min(-1))). In addition to the tip of the long tail fiber, exchange of gene products expressed in the short tail fiber may be necessary for tight binding of recombinant phage.

2004-12-01·FEMS Microbiology Letters4区 · 生物学

The coexistence ofEscherichia coliserotype O157:H7 and its specific bacteriophage in continuous culture

4区 · 生物学

Article

作者: Hajime Unno ; Masatoshi Yoichi ; Yasunori Tanji ; Curt R. Fischer

For the development of phage therapy, systematic understanding mechanisms of bacteriophage resistance will be required. We describe a new strain of Escherichia coli O157:H7, named Mu(L), which stably co-exists with the O157:H7-specific lytic bacteriophage PP01. Chemostat cultures of E. coli O157:H7 infected with PP01 showed unchanging cell concentration, but phage concentrations which increased by approximately 10(8) PFU mL(-1). However, the latent period, burst size, and growth rate of Mu(L) were the same as in a PP01-susceptible strain. The binding rate of PP01 to the cell surface was diminished 8.5-fold in Mu(L). By observation of the binding of fluorescently labeled O157:H7-specific phage to individual Mu(L) cells, we found that clonal Mu(L) cultures were heterogeneous in their ability to bind bacteriophage. 15% of the Mu(L) population was completely resistant to PP01 infection. Mu(L) also co-existed with bacteriophages unrelated to PP01. Broad-range phage resistance by clonal heterogeneity represents a new class of bacteria-phage interactions.

项与 Gabapentin/Nabilone 相关的新闻（医药）

2024-11-18

·PRNewswire

PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at AAAP Annual Meeting

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

临床1期临床结果上市批准临床2期

2024-10-07

·PRNewswire

PLEOPHARMA, INC. Strengthens Patent Portfolio with Issuance of Two U.S. Patents

2nd Patent issued in September 2024 Patent Protection to March 2041 PHOENIXVILLE, Pa., Oct. 7, 2024 /PRNewswire/ -- PleoPharma, Inc. ("PleoPharma" or the "Company), a privately held company focused on Cannabis-related health issues, announced today that it has been issued two U.S. patents with broad claims relating to methods of treating cannabis withdrawal syndrome ("CWS"). "We are pleased to have received the issuance of our second patent following up on the success of our Phase 2b trial. These U.S. patent issuances underscore the scientific achievements of PleoPharma and directly support the commercial value of our programs" said Ginger Constantine, CEO of PleoPharma. "We are excited to be developing PP-01 with the goal of being the first approved product to help people suffering from CWS, a rapidly growing patient population". U.S. Patent 11,197,846 and U.S. Patent 11,931,334, both entitled "Methods and Compositions for Treating Cannabis Use Disorder and Mitigating Cannabinoid Withdrawal," contain method of use claims for mitigating CWS drawn to specific dose ranges and detailed dosing schedules corresponding to what the Company believes will be the dosing for PP-01. The Company notes that additional patent applications are pending in the US and globally in which it is pursuing further IP development. 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, known as Cannabis Withdrawal Syndrome, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma recognizes 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 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 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

临床2期上市批准

2024-09-19

·PRNewswire

PLEOPHARMA, INC. PARTICIPATES IN THE LIFE SCIENCES PA'S LIFE SCIENCE FUTURE CONFERENCE

PHOENIXVILLE, Pa., Sept. 19, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis related health issues, announced today that their CEO, Ginger Constantine, MD, presented at the Life Sciences PA's Life Sciences Future Conference. Dr. Constantine presented data from PleoPharma's Phase 1 and Phase 2b studies of PP-01, their lead drug candidate intended for the mitigation of Cannabis Withdrawal Syndrome. 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 have received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with regular and dependent cannabis use commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. 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 in development for the mitigation of 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 that is being developed as the first FDA approved treatment for mitigation 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 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. CONTACT: [email protected] 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

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适应症	最高研发状态	国家/地区	公司	日期
大麻戒断	临床2期	美国	Pleopharma LLC	2022-10-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CAN-001 (PRNewswire) 人工标引	临床1期	大麻戒断	-	PP-01	(獵顧壓齋醖醖遞積鏇簾) = 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). 鬱觸窪艱窪願網構壓壓 (憲醖醖積簾夢窪憲構製 ) 更多	积极	2024-11-18
				Placebo