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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled study to investigate the safety and tolerability of EP395 in patients with chronic obstructive pulmonary disease (COPD)

    Summary
    EudraCT number
    		 2021-005787-22
    Trial protocol
    		 DE  
    Global end of trial date
    24 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2024
    First version publication date
    24 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP395-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05572333
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    EpiEndo Pharmaceuticals
    Sponsor organisation address
    Bjargargata 1, 102 Reykjavik, Iceland,
    Public contact
    Project Manager Kate Hanrott , EpiEndo Pharmaceuticals, +354 4540095, info@epiendo.com
    Scientific contact
    Project Manager Kate Hanrott , EpiEndo Pharmaceuticals, +354 4540095, info@epiendo.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
    23 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of repeat doses of EP395 in patients with COPD
    Protection of trial subjects
    This trial was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation Good Clinical Practice, and applicable regulatory requirements. The trial was conducted by investigators experienced in the treatment of patients with COPD.
    Background therapy
    		 Patients continued their COPD background therapy throughout the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2022
    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
    Germany: 47
    Country: Number of subjects enrolled
    United Kingdom: 14
    Worldwide total number of subjects
    61
    EEA total number of subjects
    47
    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)
    25
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 123 patients were screened. 59 patients were screening failures and 3 dropped out before randomisation. 61 patients were randomised, 42 to receive EP395 and 19 to receive placebo.

    Pre-assignment
    Screening details
    		 Patients who met all inclusion criteria and none of the exclusion criteria were eligible to participate in the trial.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    EP395 capsules and placebo capsules were identical in appearance, packaging and labelling.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EP395 375mg
    Arm description
    		 3 capsules of 125 mg EP395 each, administered once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EP395
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took 3 capsules once daily for 12 weeks (in the morning with a glass of water after an overnight fast).

    Arm title
    		 Placebo
    Arm description
    		 3 capsules of placebo, administered once daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took 3 capsules once daily for 12 weeks (in the morning with a glass of water after an overnight fast).

    Number of subjects in period 1
    		EP395 375mg Placebo
    Started
    42
    19
    Completed
    39
    18
    Not completed
    3
    1
         Adverse event, non-fatal
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EP395 375mg
    Reporting group description
    		 3 capsules of 125 mg EP395 each, administered once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 3 capsules of placebo, administered once daily for 12 weeks.

    Reporting group values
    		 EP395 375mg Placebo Total
    Number of subjects
    		 42 19 61
    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)
    		 17 8 25
        From 65-84 years
    		 25 11 36
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (46 to 82) 66 (50 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 15 9 24
        Male
    		 27 10 37
    Body mass index
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 27.20 ( 4.57 ) 26.60 ( 4.27 ) -

    End points

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    End points reporting groups
    Reporting group title
    EP395 375mg
    Reporting group description
    		 3 capsules of 125 mg EP395 each, administered once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 3 capsules of placebo, administered once daily for 12 weeks.

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    The safety and tolerability of repeat doses of EP395 in patients with COPD were evaluated by the assessment of adverse events, laboratory safety parameters, vital signs, 12-lead electrocardiograms, and physical examinations during the treatment period and follow-up.
    End point type
    Primary
    End point timeframe
    From first intake of investigational product (IP) until trial completion.
    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 primary endpoint was safety and tolerability and not associated with a hypothesis; therefore, no statistical analysis was performed.
    End point values
    		 EP395 375mg Placebo
    Number of subjects analysed
    42
    19
    Units: Subject(s)
        Any treatment-emergent adverse event (TEAE)
    27
    12
        Any TEAE related to IP
    9
    5
        Any TEAE related to any trial procedure
    2
    2
        Any TEAE leading to IP withdrawal
    3
    1
        Clinical laboratory abnormalities reported as TEAE
    2
    0
        Clinically significant (CS) changes in vital signs
    2
    0
        CS abnormalities in electrocardiogram
    0
    0
        CS findings in physical examination
    4
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs from first intake of IP until trial completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    EP395 375mg
    Reporting group description
    		 3 capsules of 125 mg EP395 each, administered once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 3 capsules of placebo, administered once daily for 12 weeks.

    Serious adverse events
    		 EP395 375mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 EP395 375mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 42 (59.52%)
    12 / 19 (63.16%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Dizziness postural
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Catheter site haematoma
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Barrett's oesophagus
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Duodenitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Toothache
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    6 / 42 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    6
    2
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Dyspnoea
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Sputum increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Wheezing
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Rash erythematous
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 42 (14.29%)
    4 / 19 (21.05%)
         occurrences all number
    7
    4
    Pulpitis dental
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2022
    Changes to v1.0: - Clarification regarding the contraception requirements for male participants - Clarification that participants lacking the capacity to understand the study would be excluded - Clarification that participants required a history of sputum production for at least 3 months (not consecutive) within the last year - Additional information confirming that flu vaccination was allowed during the trial - Additional information that participants who tested positive for Covid-19 would be allowed to remain in the trial and to continue treatment, with adjustment for remote visits, if required - New exploratory endpoints were added

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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