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    Clinical Trial Results:
    A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment.

    Summary
    EudraCT number
    		 2013-002202-31
    Trial protocol
    		 GB   ES   DE  
    Global end of trial date
    08 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2017
    First version publication date
    08 Jun 2017
    Other versions
    Summary report(s)
    		 Synopsis_CSR_2013-002202-31

    Trial information

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    Trial identification
    Sponsor protocol code
    POL7080-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02096315
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Polyphor Ltd
    Sponsor organisation address
    411 Tower Bridge Business Centre, 46-48 East Smithfield, London, United Kingdom, E1W 1AW
    Public contact
    Leon Hooftman, M.D., Polyphor Ltd, +41 615671600, Leon.Hooftman@polyphor.com
    Scientific contact
    Leon Hooftman, M.D., Polyphor Ltd, +41 615671600, Leon.Hooftman@polyphor.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of POL7080 administered for 10 to 14 days in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.
    Protection of trial subjects
    The patient health status was closely monitored throughout the study. If changes in their well-being or laboratory results or other findings develop during the course of the trial which indicated that their health had been impaired and was at risk, the Study Doctor was obliged to take all medically necessary measures to restore their previous state of health and to keep the changes under control until they had normalized again. As a precaution, male patients were to practice contraception during the treatment period and up to 75 days after the end of treatment. Currently, the effects of POL7080 on the embryo/foetal development of pregnant woman and fertility in man are not known. If the patient was a woman of child bearing potential (capable of becoming pregnant) she had to practice a reliable method of contraception (such as continuation of contraception pills, abstinence, double protection i.e. condom and diaphragm).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was planned to included 20 patients. FPFV: Feb 3, 2014, LPLV: Nov 26, 2014. Recruitment was temporarily halted in December 2014 due to discordance between clinical improvement and microbiological response, and terminated on October 8, 2015 due to futility in achieving a positive microbiological response in this particular study setting.

    Pre-assignment
    Screening details
    		 Inclusion criteria: adults ≥18 to <80 with non-cystic fibrosis bronchiectasis, with exacerbation with increased cough, sputum production or sputum purulence, current infection/chronically infected with Pseudomonas aeruginosa, and sputum sample collected for quantitative culture. All screened patients were enrolled, there were not screening failure.

    Pre-assignment period milestones
    Number of subjects started
    		 12
    Number of subjects completed
    		 12

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treated with POL7080
    Arm description
    		 All screened and enrolled patients received treatment with POL7080
    Arm type
    		 Experimental

    Investigational medicinal product name
    POL7080
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    POL7080 was administered as intravenous infusion at a dose of 2.5mg/kg, 2-hour infusion, three times daily for 10 to 14 days.

    Number of subjects in period 1
    		Treated with POL7080
    Started
    12
    Completed
    4
    Not completed
    8
         Absence of Pseudomonas aeruginosa infection
    3
         Abnormal laboratory value
    1
         Due to proteinuria
    1
         Low Pseudomonas aeruginosa count
    2
         Absence of symptom improvement
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.6 ± 11.05 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 1 1
    Race
    Units: Subjects
        Caucasian
    		 12 12
        Black
    		 0 0
        Asian/Oriental
    		 0 0
        Other
    		 0 0
    Weight (kg)
    Units: Subjects
        <60kg
    		 7 7
        60 to <80 kg
    		 5 5
        80 to <100 kg
    		 0 0
        >=100 kg
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled patients who received at least one dose of POL7080.

    Subject analysis set title
    PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients who received at least one dose of POL7080 and at least one valid post infusion pharmacokinetic assessment.

    Subject analysis set title
    mITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients with documented Pseudomonas aeruginosa infection (i.e., 105 cfu/mL) at baseline and who received at least one dose of POL7080.

    Subject analysis sets values
    		 Safety population PK population mITT population
    Number of subjects
    12
    12
    5
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    6
    6
    2
        From 65-84 years
    6
    6
    3
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.6 ± 11.05
    64.6 ± 11.05
    64.6 ± 15.87
    Gender categorical
    Units: Subjects
        Female
    11
    11
    5
        Male
    1
    1
    0
    Race
    Units: Subjects
        Caucasian
    12
    12
    5
        Black
    0
    0
    0
        Asian/Oriental
    0
    0
    0
        Other
    0
    0
    0
    Weight (kg)
    Units: Subjects
        <60kg
    7
    7
    4
        60 to <80 kg
    5
    5
    1
        80 to <100 kg
    0
    0
    0
        >=100 kg
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Treated with POL7080
    Reporting group description
    		 All screened and enrolled patients received treatment with POL7080

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled patients who received at least one dose of POL7080.

    Subject analysis set title
    PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients who received at least one dose of POL7080 and at least one valid post infusion pharmacokinetic assessment.

    Subject analysis set title
    mITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients with documented Pseudomonas aeruginosa infection (i.e., 105 cfu/mL) at baseline and who received at least one dose of POL7080.

    Primary: Sputum Bacterial clearance of Pseudomonas aeruginosa

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    End point title
    		 Sputum Bacterial clearance of Pseudomonas aeruginosa [1]
    End point description
    The primary efficacy variable is the Sputum Bacterial clearance [reduction in the daily quantitative viable counts (cfu/mL) of Pseudomonas aeruginosa by at least 1-log] in subjects with baseline P. aeruginosa ≥ 100,000 cfu/mL.
    End point type
    Primary
    End point timeframe
    Test of Cure (TOC) was the time of the primary endpoint assessment at 4±1 day after EOT (end of treatment).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The number and percentage (plus 95% CI) of patients in the mITT analysis set with reduction in the quantitative viable counts (cfu/mL) of Pseudomonas aeruginosa by at least 1-log at TOC was presented. Evolution of bacterial viable counts was summarised for the absolute and change from baseline values by visit. Confidence intervals for point estimates where appropriate were 95% (i.e. using a 5% significance level). No adjustment for multiple comparisons or corrections for multiplicity was planned
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: number of patients
        Patients with 1-log reduction
    1
        Patients with no 1-log reduction
    4
    No statistical analyses for this end point

    Secondary: Time to 1-log reduction of Pseudomonas aeruginosa as compared to baseline

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    End point title
    		 Time to 1-log reduction of Pseudomonas aeruginosa as compared to baseline
    End point description
    Time to 1 log reduction of Pseudomonas aeruginosa as compared to baseline: In patients who had at least 1X100,000 P. aeruginosa grown in the baseline quantitative culture of the sputum, the time difference between the baseline culture and the first of the 2 consecutive samples with 1-log reduction will be calculated as the time to log reduction.
    End point type
    Secondary
    End point timeframe
    Any time (to 1 log reduction) compared to baseline
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: days
        arithmetic mean (standard deviation)
    3.5 ± 2.12
    No statistical analyses for this end point

    Secondary: Clinical status assessment

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    End point title
    		 Clinical status assessment
    End point description
    Clinical status assessment was based on the clinical signs and symptoms of the patient and was assessed at treatment visits 4 and 10, EOT, and TOC. During the earlier treatment visit 4 there was no documented change in clinical status whereas at treatment visit 10 and EOT there were two (40.0%) subjects who exhibited improved status (three [60.0%] subjects had missing status. At TOC, two (40.0%) subjects exhibited improved clinical status, while the remaining three (60.0%) subjects had an unchanged status. No subject in the mITT group showed a worsening of clinical status.
    End point type
    Secondary
    End point timeframe
    It was assessed at visit 4 (day 4), visit 10 (day 10), end of treatment (EOT), and test of cure (TOC).
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: number of patients
        Visit 4 - returned to preexacerbation state
    0
        Visit 4 - Improved
    0
        Visit 4 - Unchanged
    4
        Visit 4 - Worsened
    0
        Visit 4 - Missing
    1
        Visit 10 - returned to preexacerbation state
    0
        Visit 10 - Improved
    2
        Visit 10 - Unchanged
    0
        Visit 10 - Worsened
    0
        Visit 10 - Missing
    3
        EOT - Returned to preexacerbation state
    0
        EOT - Improved
    2
        EOT - Unchanged
    0
        EOT - Worsened
    0
        EOT - Missing
    3
        TOC - Returned to preexacerbation state
    0
        TOC - Improved
    2
        TOC - Unchanged
    3
        TOC - Worsened
    0
    No statistical analyses for this end point

    Secondary: 24-hour sputum volume

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    End point title
    		 24-hour sputum volume
    End point description
    End point type
    Secondary
    End point timeframe
    This was assessed at visits 4, 10, EOT and TOC.
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: mL
    arithmetic mean (standard deviation)
        Screening visit
    18.8 ± 11.09
        Treatment visit 4
    20.8 ± 19.43
        Treatment visit 10
    5.5 ± 6.36
        Treatment visit EOT
    5.5 ± 6.36
        Treatment visit TOC
    20.8 ± 13.83
    No statistical analyses for this end point

    Secondary: Sputum purulence score

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    End point title
    		 Sputum purulence score
    End point description
    Sputum purulence score is calculated as 3 for purulent sputum, 2 for muco-purulent sputum and 1 for mucoid sputum. At EOT visit only one patient had sputum purulence score, a zero (0) had added in the SD box due to the inability to leave the value box empty. When SD=0, it has been indicated as 0.0
    End point type
    Secondary
    End point timeframe
    This was assessed at visits 4, 10, EOT and TOC
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: Score
    arithmetic mean (standard deviation)
        Screening visit
    3 ± 0
        Treatment visit 4
    2.8 ± 0.5
        Treatment visit 10
    2.5 ± 0.71
        Treatment visit EOT
    3 ± 0
        Treatment visit TOC
    3 ± 0
    No statistical analyses for this end point

    Secondary: Change in lung function - FEV1

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    End point title
    		 Change in lung function - FEV1
    End point description
    End point type
    Secondary
    End point timeframe
    It was assessed at screening visit, visit 7, EOT and TOC.
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: % predicted
    arithmetic mean (standard deviation)
        Screening visit (baseline)
    72 ± 7.53
        Visit 7 - change from baseline
    2 ± 18.38
        EOT - change from baseline
    15 ± 9.9
        TOC - change from baseline
    -1.3 ± 22.28
    No statistical analyses for this end point

    Secondary: Patient reported outcome - St George's Respiratory questionnaire (SGRQ)

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    End point title
    		 Patient reported outcome - St George's Respiratory questionnaire (SGRQ)
    End point description
    End point type
    Secondary
    End point timeframe
    The questionnaire was administered at screening and TOC visits.
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: Score
    arithmetic mean (standard deviation)
        Total score - screening visit
    60.3 ± 19.44
        Total score - TOC
    70.3 ± 15.23
        Total score - change from baseline (screening)
    2.7 ± 3.84
        Symtoms score - screening visit
    76 ± 14.98
        Symptoms score - TOC
    69.8 ± 19.4
        Symptoms score - change from baseline (screening)
    -6.2 ± 10.35
        Activity score - screening visit
    63.4 ± 31.53
        Activity score - TOC
    65 ± 33.92
        Activity score - change from baseline
    1.6 ± 4.98
        Impacts score - screening visit
    54.2 ± 18.11
        Impacts score - TOC
    63.8 ± 20.13
        Impacts score - change from baseline (sceening)
    3.9 ± 6.68
    No statistical analyses for this end point

    Secondary: Pharmacokinetic analysis

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    End point title
    		 Pharmacokinetic analysis
    End point description
    The following pharmacokinetic parameters were assessed for POL7080: maximum plasma concentration (Cmax), the area under the plasma concentration versus time curve during a dosing interval (AUC [0-8h]), terminal elimination half-life (t½), systemic plasma clearance (CL), volume of distribution at steady state (Vss), volume of distribution based on the terminal phase following intravenous administration (Vz), and mean residence time (MRT).
    End point type
    Secondary
    End point timeframe
    Pharmacokinetic parameters were assessed for POL7080 on day 3.
    End point values
    		 PK population
    Number of subjects analysed
    12
    Units: Several units
    arithmetic mean (standard deviation)
        Cmax (ng/mL)
    7417 ± 1577.57
        Tmax (h)
    1.87 ± 0.35
        AUC(0-8h) (h*ng/L)
    34418.7 ± 6521.93
        Mean residence time (min)
    357.52 ± 84.57
        Clearance (L/h)
    4.0181 ± 0.6
        Volume, steady-state (L)
    23.602 ± 5.43
    No statistical analyses for this end point

    Secondary: Assessment of clinical signs and symptoms at TOC

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    End point title
    		 Assessment of clinical signs and symptoms at TOC
    End point description
    In each category, it has been indicated the number of patients (from mITT population) for this category. Only data of changed/unchanged status at TOC visit is specified.
    End point type
    Secondary
    End point timeframe
    Clinical status assessment was based on the clinical signs and symptoms of the patient and was assessed at treatment visits 4 and 10, EOT, and TOC.
    End point values
    		 mITT population
    Number of subjects analysed
    5
    Units: number of patients
        Cough - TOC (N=5) - Improved
    2
        Cough - TOC (N=5) - Unchanged
    3
        Sputum production - TOC (N=5) - Improved
    2
        Sputum production - TOC (N=5) - Unchanged
    3
        Sputum colour (purulent) - TOC (N=3) - Improved
    1
        Sputum colour (purulent) - TOC (N=3) - Unchanged
    2
        Dyspnea - TOC (N=5) - Improved
    2
        Dyspnea - TOC (N=5) - Unchanged
    3
        Fatigue (Yes) - TOC (N=5) - Improved
    2
        Fatigue (Yes) - TOC (N=5) - Unchanged
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event were collected during all the study (screening period, treatment period, EOT and TOC)
    Adverse event reporting additional description
    AEs were collected from the time of signing the informed consent to the TOC. Patients were carefully monitored for the occurrence of AEs. All AEs must be recorded in the CRF and should include: brief description of the event, start date, stop date, severity, action taken regarding study drug, opinion on causality, seriousness, and outcome.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 All screened and enrolled patients that received at least one dose of POL7080

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Infusion site phlebitis
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Infusion site pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    4
    Infusion site pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Paraesthesia oral
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2014
    This substantial amendment (submitted to regulatory authorities in all participating countries) was made in order to allow a total treatment duration of 10 to 14 days for POL7080 instead of a fixed duration of 14 days. The justification for this amendment was that it aligned the study with the current practice of using 10 to 14 days of treatment with co-administered SoC anti-pseudomonas antibiotic(s). Furthermore, it provided greater flexibility to the treating physician whereby the investigator could decide when to stop POL7080 treatment after 10 days at his own discretion and based on the patient’s condition.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Oct 2015
    Temporary interruption: Investigator notification of temporary hold on enrolment (18 December 2014): The letter from the chief medical officer, Dr. Leon Hooftman, informing all investigators of the study’s enrolment being placed on a temporary hold. Regulatory authority notification of study temporarily on hold (December 2014): Notification was submitted in Spain on 19 December 2014. The submission to the UK and Germany was delivered on the 22 December 2014 as a substantial amendment, as per the request of the MHRA and BfArM, respectively. Permanent interruption: Investigator notification of study termination (08 October 2015): The letter from the chief medical officer, Dr. Leon Hooftman, informing all investigators of the decision to terminate the study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was early terminated (not initiated in Germany/Netherlands) due to the lack of reduction in CFU (primary end-point), possibly influenced by routine inhalational antibiotics. The majority of patients showed benefits in clinical assessments.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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