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    Clinical Trial Results:
    Randomised, double-blind, placebo-controlled study of the, efficacy, safety and tolerability of EPA-FFA gastro-resistant capsules, in patients with familial adenomatous polyposis (FAP)

    Summary
    EudraCT number
    		 2017-002809-34
    Trial protocol
    		 CZ   NL   DE   IT   DK   PL   BE  
    Global end of trial date
    25 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2026
    First version publication date
    09 Aug 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EPA-POL-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SLA Pharma Ltd.
    Sponsor organisation address
    3a Chestnut House, Farm Close, Shenley, United Kingdom, WD7 9AD
    Public contact
    Justin Slagel, SLA Pharma (UK) Ltd., jslagel@slapharma.com
    Scientific contact
    Justin Slagel, SLA Pharma (UK) Ltd., jslagel@slapharma.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 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of eicosapentaenoic acid free fatty acid (EPA-FFA) gastro-resistant capsules in patients with FAP in reducing polypectomy.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and the principles of ICH Good Clinical Practice, and was approved by the competent regulatory authorities and independent ethics committees in each participating country. Written informed consent was obtained from every subject before any trial-specific procedure. The trial was categorised as risk Type B; the IMP (EPA-FFA) is an omega-3 free fatty acid generally regarded as safe when given orally, with adverse events in prior experience being predominantly minor gastrointestinal effects. Subject safety was monitored through scheduled physical examinations and haematology/biochemistry testing, a telephone contact in week 1 and every other month thereafter to assess IMP tolerability, and a subject diary for adverse events; subjects with persistent clinically significant adverse events were seen at an additional unscheduled visit. SUSAR reporting and Development Safety Update Reports were maintained by Pharmacovigilance/the Medical Monitor. To minimise pain and distress, sigmoidoscopy procedures were performed after bowel preparation with sedation according to local standard of care, and blood samples were taken by venepuncture; rectal polyps ≤5 mm were left in place unless clinically indicated, avoiding unnecessary intervention. Women of childbearing potential were required to use contraception and underwent urine pregnancy testing at visits, with defined pregnancy-reporting and withdrawal procedures, and subjects were free to withdraw at any time. Clinical trial insurance/indemnity was in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2018
    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
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 68
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Israel: 4
    Worldwide total number of subjects
    120
    EEA total number of subjects
    116
    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)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects with FAP were recruited at specialist gastroenterology sites in Belgium, Czech Republic, Denmark, France, Germany, Israel, Italy, Netherlands, Poland and Spain (a Swedish site was initiated but recruited none). Recruitment ran 05 Dec 2018 (first consent) to 17 Jul 2023 (last randomised).

    Pre-assignment
    Screening details
    		 Subjects were screened at Visit 1 (Day −14±7) for FAP eligibility (APC mutation, prior colectomy, IPSS stage 1–3). No run-in; fish-oil required a 2-month wash-out and NSAIDs stopped ≥3 months pre-entry (low-dose aspirin allowed).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Double-blind. Randomisation, labelling and packaging were done by an independent contractor, so subjects, investigators and the Sponsor stayed blinded. Active and placebo capsules were identical in appearance and packs, assigned 1:1 via IWRS. Emergency code-breaks were available 24h via the e-CRF, only for medical emergencies or SUSAR reporting.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EPA-FFA
    Arm description
    		 EPA-FFA 500 mg gastro-resistant capsules, 2 g/day taken as two capsules twice daily, orally, for up to 24 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eicosapentaenoic acid free fatty acid (EPA-FFA) gastro-resistant capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Each capsule contains 500 mg EPA-FFA. Dose 2 g/day, taken as two 500 mg capsules twice daily (4 capsules/day), for up to 24 months. Capsule shell: gelatin, glycerol, sorbitol, titanium dioxide, FD&C Blue No. 1, hypromellose phthalate, dibutyl sebacate.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo gastro-resistant capsules (identical in appearance), two capsules twice daily, orally, for up to 24 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Each capsule contains 500 mg mixed-chain triglycerides (placebo). Regimen matched to active: two capsules twice daily (4 capsules/day), for up to 24 months. Identical in appearance to the active IMP. Capsule shell: gelatin, glycerol, sorbitol, titanium dioxide, FD&C Blue No. 1, hypromellose phthalate, dibutyl sebacate.

    Number of subjects in period 1
    		EPA-FFA Placebo
    Started
    61
    59
    Completed
    41
    38
    Not completed
    20
    21
         Consent withdrawn by subject
    6
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    4
    3
         Other
    1
    7
         Pregnancy
    -
    1
         Non-compliance with study drug
    1
    2
         Use of prohibited medication
    1
    -
         Lost to follow-up
    3
    2
         Study ended (sponsor close-out)
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 120 120
    Age categorical
    Age was recorded in years and categorised into the standard age bands. All subjects were adults (≥18 years) with familial adenomatous polyposis (FAP); no subjects under 18 were enrolled. Values are reported for all randomised subjects.
    Units: Subjects
        Adults (18-64 years)
    		 120 120
    Age continuous
    Age was recorded in years and categorised into the standard age bands. All subjects were adults (≥18 years) with familial adenomatous polyposis (FAP); no subjects under 18 were enrolled. Values are reported for all randomised subjects.
    Units: years
        arithmetic mean (standard deviation)
    		 41.5 ( 12.9 ) -
    Gender categorical
    Gender was recorded at baseline as reported by the subject/investigator and categorised as female or male. All subjects were adults with familial adenomatous polyposis (FAP). Values are reported for all randomised subjects.
    Units: Subjects
        Female
    		 52 52
        Male
    		 68 68
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat (ITT) analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) analysis set is defined as all randomised subjects. Subjects are analysed according to their planned (randomised) treatment. The ITT set comprises 120 subjects (61 EPA-FFA, 59 placebo) and was the primary analysis set for efficacy.

    Subject analysis sets values
    		 Intention-to-treat (ITT) analysis set
    Number of subjects
    120
    Age categorical
    Age was recorded in years and categorised into the standard age bands. All subjects were adults (≥18 years) with familial adenomatous polyposis (FAP); no subjects under 18 were enrolled. Values are reported for all randomised subjects.
    Units: Subjects
        Adults (18-64 years)
    120
    Age continuous
    Age was recorded in years and categorised into the standard age bands. All subjects were adults (≥18 years) with familial adenomatous polyposis (FAP); no subjects under 18 were enrolled. Values are reported for all randomised subjects.
    Units: years
        arithmetic mean (standard deviation)
    41.5 ( 12.9 )
    Gender categorical
    Gender was recorded at baseline as reported by the subject/investigator and categorised as female or male. All subjects were adults with familial adenomatous polyposis (FAP). Values are reported for all randomised subjects.
    Units: Subjects
        Female
    52
        Male
    68

    End points

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    End points reporting groups
    Reporting group title
    EPA-FFA
    Reporting group description
    		 EPA-FFA 500 mg gastro-resistant capsules, 2 g/day taken as two capsules twice daily, orally, for up to 24 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo gastro-resistant capsules (identical in appearance), two capsules twice daily, orally, for up to 24 months.

    Subject analysis set title
    Intention-to-treat (ITT) analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to-treat (ITT) analysis set is defined as all randomised subjects. Subjects are analysed according to their planned (randomised) treatment. The ITT set comprises 120 subjects (61 EPA-FFA, 59 placebo) and was the primary analysis set for efficacy.

    Primary: Total number of polypectomies (polyps >5 mm in the rectum) over the 24-month study period

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    End point title
    		 Total number of polypectomies (polyps >5 mm in the rectum) over the 24-month study period
    End point description
    End point type
    Primary
    End point timeframe
    From start of treatment to the Month-24 visit (cumulative)
    End point values
    		 EPA-FFA Placebo
    Number of subjects analysed
    56
    52
    Units: Polypectomy
        number (confidence interval 95%)
    3.06 (2.14 to 4.38)
    4.54 (2.80 to 7.37)
    Statistical analysis title
    		 EPA-FFA vs Placebo (arms) ITT
    Comparison groups
    EPA-FFA v Placebo
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1825
    Method
    		 GEE negative binomial
    Parameter type
    		 Mean ratio
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.2

    Secondary: Change in polyp number from baseline to Month 24 (blinded video review)

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    End point title
    		 Change in polyp number from baseline to Month 24 (blinded video review)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 24
    End point values
    		 EPA-FFA Placebo
    Number of subjects analysed
    54
    52
    Units: Polyps
        least squares mean (confidence interval 95%)
    6.45 (-1.25 to 14.15)
    10.33 (2.60 to 18.06)
    Statistical analysis title
    		 EPA-FFA vs Placebo (arm) ITT
    Comparison groups
    EPA-FFA v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4794
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.73
         upper limit
    		 6.98

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent: first dose to the Month-24 visit (or early withdrawal +1 day)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    EPA-FFA
    Reporting group description
    		 EPA-FFA 500 mg gastro-resistant capsules, 2 g/day taken as two capsules twice daily, orally, for up to 24 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo gastro-resistant capsules (identical in appearance), two capsules twice daily, orally, for up to 24 months.

    Serious adverse events
    		 EPA-FFA Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 60 (8.33%)
    6 / 58 (10.34%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal neoplasm
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Vascular occlusion
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EPA-FFA Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 60 (71.67%)
    43 / 58 (74.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 60 (15.00%)
    10 / 58 (17.24%)
         occurrences all number
    21
    37
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 60 (3.33%)
    4 / 58 (6.90%)
         occurrences all number
    2
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 60 (20.00%)
    16 / 58 (27.59%)
         occurrences all number
    20
    36
    Abdominal pain
         subjects affected / exposed
    6 / 60 (10.00%)
    6 / 58 (10.34%)
         occurrences all number
    8
    14
    Toothache
         subjects affected / exposed
    5 / 60 (8.33%)
    6 / 58 (10.34%)
         occurrences all number
    6
    6
    Abdominal pain upper
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 58 (5.17%)
         occurrences all number
    6
    4
    Dyspepsia
         subjects affected / exposed
    3 / 60 (5.00%)
    4 / 58 (6.90%)
         occurrences all number
    4
    4
    Nausea
         subjects affected / exposed
    5 / 60 (8.33%)
    1 / 58 (1.72%)
         occurrences all number
    5
    1
    Abdominal distension
         subjects affected / exposed
    0 / 60 (0.00%)
    5 / 58 (8.62%)
         occurrences all number
    0
    6
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
         occurrences all number
    1
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 60 (3.33%)
    6 / 58 (10.34%)
         occurrences all number
    2
    8
    Influenza
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 58 (3.45%)
         occurrences all number
    7
    4
    COVID-19
         subjects affected / exposed
    5 / 60 (8.33%)
    7 / 58 (12.07%)
         occurrences all number
    5
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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