Delving into the Latest Updates on Antimicrobial Peptides PL-18 with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

PL-18 polypeptide suppository, PL-18 suppository

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesUrogenital Diseases

Active Indication

ColpomycosisCandidiasis, VulvovaginalBacterial Infections and Mycoses+ [1]

Inactive Indication-

Originator Organization

Protelight Pharmaceuticals

Active Organization

Protelight PharmaceuticalsProtelight Pharmaceuticals Australia PTY LTD

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的：评估抗菌肽PL-18栓在健康成年女性志愿者中单次给药的安全性和耐受性。次要目的： 1）评估抗菌肽PL-18栓在健康成年女性志愿者中单次给药的药代动力学（PK）特征； 2) 评估抗菌肽PL-18栓对健康成年女性志愿者单次给药后阴道菌群的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of single-dose antimicrobial peptide PL-18 suppositories in healthy adult female volunteers. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of single-dose antimicrobial peptide PL-18 suppositories in healthy adult female volunteers; 2) To evaluate the effect of antimicrobial peptide PL-18 suppositories on vaginal flora in healthy adult female volunteers after single-dose administration.

Start Date-

Sponsor / Collaborator

Protelight Pharmaceuticals

CTR20232467

/ RecruitingPhase 1/2

一项评估抗菌肽PL-18栓在外阴阴道假丝酵母菌病患者中多次给药的安全耐受性、药代动力学特征及有效性的随机、双盲、安慰剂对照的Ⅰb/Ⅱ期临床研究

[Translation] A randomized, double-blind, placebo-controlled phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of multiple doses of the antimicrobial peptide PL-18 suppository in patients with vulvovaginal candidiasis

Ⅰb期试验主要目的：评估抗菌肽PL-18栓在VVC患者中多次给药的安全性和耐受性。次要目的： 1）评估抗菌肽PL-18栓在VVC患者中多次给药的药代动力学（PK）特征； 2）评估抗菌肽PL-18栓治疗VVC的有效性； 3）评估抗菌肽PL-18栓对VVC病患者中多次给药后阴道菌群的影响。探索性目的： 1）探索抗菌肽PL-18栓对VVC患者细胞因子水平的影响。 2）探索抗菌肽PL-18栓的免疫原性。 Ⅱ期试验主要目的：评价抗菌肽PL-18栓治疗VVC的有效性。次要目的：评价抗菌肽PL-18栓在VVC患者中的安全性和耐受性。

[Translation]

Phase Ib trial Main purpose: To evaluate the safety and tolerability of multiple administrations of antimicrobial peptide PL-18 suppositories in patients with VVC. Secondary purpose: 1) To evaluate the pharmacokinetic (PK) characteristics of multiple administrations of antimicrobial peptide PL-18 suppositories in patients with VVC; 2) To evaluate the effectiveness of antimicrobial peptide PL-18 suppositories in the treatment of VVC; 3) To evaluate the effect of antimicrobial peptide PL-18 suppositories on vaginal flora in patients with VVC after multiple administrations. Exploratory purpose: 1) To explore the effect of antimicrobial peptide PL-18 suppositories on cytokine levels in patients with VVC. 2) To explore the immunogenicity of antimicrobial peptide PL-18 suppositories. Phase II trial Main purpose: To evaluate the effectiveness of antimicrobial peptide PL-18 suppositories in the treatment of VVC. Secondary purpose: To evaluate the safety and tolerability of antimicrobial peptide PL-18 suppositories in patients with VVC.

Start Date16 Sep 2023

Sponsor / Collaborator

Protelight Pharmaceuticals

NCT05340790

/ RecruitingPhase 1

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories in Healthy Adult Subjects

This is a Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and PK Profiles of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories.

Start Date01 Aug 2022

Sponsor / Collaborator

Protelight Pharmaceuticals Australia PTY LTD

100 Clinical Results associated with Antimicrobial Peptides PL-18

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100 Translational Medicine associated with Antimicrobial Peptides PL-18

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100 Patents (Medical) associated with Antimicrobial Peptides PL-18

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2

Literatures (Medical) associated with Antimicrobial Peptides PL-18

01 Dec 2024·Biofilm

Pseudomonas aeruginosa quorum sensing and biofilm attenuation by a di-hydroxy derivative of piperlongumine (PL-18)

Article

Author: Schlichter Kadosh, Yael ; Shagan, Marilou ; Gopas, Jacob ; Mehlman, Tevie ; Ben-Zvi, Anat ; Saravana Kumar, Rajendran ; Brandis, Alexander ; Nisaa, Khairun ; Muthuraman, Subramani ; Karsagi Byron, Danit Lisa ; Kushmaro, Ariel

Bacterial communication, Quorum Sensing (QS), is a target against virulence and prevention of antibiotic-resistant infections. 16 derivatives of Piperlongumine (PL), an amide alkaloid from Piper longum L., were screened for QS inhibition. PL-18 had the best QSI activity. PL-18 inhibited the lasR-lasI, rhlR-rhlI, and pqs QS systems of Pseudomonas aeruginosa. PL-18 inhibited pyocyanin and rhamnolipids that are QS-controlled virulence elements. Iron is an essential element for pathogenicity, biofilm formation and resilience in harsh environments, its uptake was inhibited by PL-18. Pl-18 significantly reduced the biofilm biovolume including in established biofilms. PL-18-coated silicon tubes significantly inhibited biofilm formation. The transcriptome study of treated P. aeruginosa showed that PL-18 indeed reduced the expression of QS and iron homeostasis related genes, and up regulated sulfur metabolism related genes. Altogether, PL-18 inhibits QS, virulence, iron uptake, and biofilm formation. Thus, PL-18 should be further developed against bacterial infection, antibiotic resistance, and biofilm formation.

01 Jan 2015·European Journal of Clinical Microbiology & Infectious DiseasesQ3 · MEDICINE

Functional synergy of α-helical antimicrobial peptides and traditional antibiotics against Gram-negative and Gram-positive bacteria in vitro and in vivo

Q3 · MEDICINE

Article

Author: Li, G ; Huang, Y ; Feng, Q ; Chen, M ; Chen, Y

In this study, the antimicrobial activities based on the synergistic effects of traditional antibiotics (imipenem, cefepime, levofloxacin hydrochloride and vancomycin) and antimicrobial peptides (AMPs; PL-5, PL-31, PL-32, PL-18, PL-29 and PL-26), alone or in combination, against three Gram-positive bacteria (Staphylococcus aureus, Streptococcus pneumoniae and Staphylococcus epidermidis) and three Gram-negative bacteria (Pseudomonas aeruginosa, Escherichia coli and Klebsiella pneumoniae) were investigated. In addition, the antimicrobial activity that was based on the synergistic effects of levofloxacin hydrochloride and PL-5 against Staphylococcus aureus in vivo was explored in a mouse infection model. Traditional antibiotics and AMPs showed significant synergistic effects on the antibacterial activities against the different Gram-positive and Gram-negative bacteria in vitro. A strong synergistic effect in the PL-5 and levofloxacin hydrochloride combination against Staphylococcus aureus was observed in the mouse infection model in vivo. The mechanism of synergistic action was due to the different targets of AMPs and traditional antibiotics. The combination of AMPs and traditional antibiotics can dramatically enhance antimicrobial activity and may help prevent or delay the emergence of antibiotic resistance. Thus, this combination therapy could be a promising approach to treat bacterial infections, particularly mixed infections and multi-antibiotic-resistant infections, in the clinics.

100 Deals associated with Antimicrobial Peptides PL-18

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	Phase 2	China	Protelight Pharmaceuticals	16 Sep 2023
Colpomycosis	Phase 2	China	Protelight Pharmaceuticals	-
Colpomycosis	Phase 2	United States	Protelight Pharmaceuticals	-
Bacterial Infections and Mycoses	Phase 1	-	Protelight Pharmaceuticals	14 Jun 2023
Bacterial Vaginosis	Phase 1	Australia	Protelight Pharmaceuticals Australia PTY LTD	01 Aug 2022

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Biosimilar

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