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    Clinical Trial Results:
    A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients with Idiopathic Pulmonary Fibrosis

    Summary
    EudraCT number
    		 2022-000498-15
    Trial protocol
    		 IT   CZ   ES   HU   AT   PL  
    Global end of trial date
    09 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2025
    First version publication date
    25 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RXC007/0002
    Additional study identifiers
    ISRCTN number
    		 ISRCTN60385283
    US NCT number
    		 NCT05570058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Redx Pharma Ltd.
    Sponsor organisation address
    Block 33, Mereside, Alderley Park, Alderley Edge, Cheshire, United Kingdom, SK10 4TG
    Public contact
    Chief Medical Officer, Redx Pharma Ltd., +44 (0)1625 469900, h.timmis@redxpharma.com
    Scientific contact
    Chief Medical Officer, Redx Pharma Ltd., +44 (0)1625 469900, h.timmis@redxpharma.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
    05 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or pirfenidone.
    Protection of trial subjects
    The rights, safety and well-being of subjects were protected in accordance with the Declaration of Helsinki, ICH GCP and all applicable regulatory requirements. The protocol, informed consent form and related documents received prior approval from Independent Ethics Committees/Institutional Review Boards before study initiation. Written informed consent was obtained from each participant prior to screening or any protocol-specific procedure, ensuring subjects were fully informed of the study objectives, potential risks and benefits, and their right to withdraw at any time. A Dose Review Committee (DRC) oversaw subject safety, reviewing data after at least 28 days of dosing in each cohort before dose escalation. Enrolment was paused if two or more subjects experienced similar severe or serious adverse events until the DRC completed a review. Safety monitoring included scheduled physical examinations, vital signs, electrocardiograms, and laboratory assessments. Adverse events, serious adverse events, and adverse events of special interest were collected and reported in accordance with protocol-defined procedures and regulatory timelines. The protocol included predefined withdrawal and discontinuation criteria to protect participants from undue risk. Subjects who discontinued treatment remained under follow-up for safety evaluation. Data confidentiality was maintained by assigning each participant a unique trial number; no directly identifying information was used in study records. Insurance coverage was provided in line with regulatory requirements to ensure compensation in the event of trial-related injury. These measures, together with continuous monitoring and oversight, ensured that the rights and safety of all participants were appropriately safeguarded throughout the trial.
    Background therapy
    		 In this study, background therapy for idiopathic pulmonary fibrosis (IPF) was permitted in the form of either nintedanib or pirfenidone, provided the patient had been on a stable dose for at least 8 weeks prior to first administration of the investigational product. Patients could not receive both agents simultaneously, and initiation of background therapy during the study was not permitted; any new start of nintedanib or pirfenidone was considered disease progression and reported as a protocol deviation. Patients not receiving background IPF therapy at study entry continued without it. Randomisation to RXC007 or placebo occurred independently of background therapy, meaning patients could be randomised while on nintedanib, pirfenidone, or no antifibrotic therapy. Concomitant medications considered necessary for patient welfare were permitted if judged by the investigator not to interfere with study treatment, and all such medications were recorded in the eCRF. However, several restrictions were imposed. Systemic steroids (other than inhaled or topical) and anticoagulants (except antiplatelet agents) were prohibited throughout the trial In addition, herbal supplements and medications affecting relevant enzyme systems (e.g., CYP1A2, CYP2B6, CYP3A4) were restricted, and specific drug–drug interaction precautions applied to patients on pirfenidone or nintedanib. COVID-19 vaccination was permitted before or during study treatment, apart from live-attenuated or replication-competent vector vaccines, which were prohibited within 4 weeks of starting study therapy and during the treatment period Overall, background therapy was carefully managed to ensure consistency, minimise confounding effects, and maintain patient safety, with strict adherence to predefined restrictions.
    Evidence for comparator
    		 This study used placebo as the comparator. The reason for using placebo was to clearly see the effects of RXC007 on patients with idiopathic pulmonary fibrosis (IPF). By comparing RXC007 with placebo, any differences in safety or activity could be directly linked to the study drug, without interference from other treatments. The design reduced risk for patients on placebo. A 3:1 randomisation meant more patients received RXC007 than placebo, and the double-blind period lasted only 12 weeks, which is short compared to the slow progression of IPF. After this period, all patients had the option to continue in an open-label extension where they could receive RXC007. Patients could be enrolled whether they were already on a stable background antifibrotic therapy (nintedanib or pirfenidone) or not. Randomisation ensured balance between the groups so that comparisons would be justified. Placebo was chosen because they gave a clear comparison, reduced bias, and supported reliable measurement of RXC007’s effect. The short study period, 3:1 randomisation, and open-label extension ensured patients were not exposed to unnecessary risk while using a placebo in the study.
    Actual start date of recruitment
    21 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Czechia: 2
    Worldwide total number of subjects
    48
    EEA total number of subjects
    22
    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)
    11
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment began on 08 Nov 2022 and ended on 09 Jan 2025. Patients with IPF were enrolled across European centres and randomised 3:1 to RXC007 or placebo. A total of 49 patients were randomised; 48 received at least one dose of study treatment.

    Pre-assignment
    Screening details
    		 Screening included medical history, physical exam, pulmonary function tests, HRCT confirmation of IPF, vital signs, ECG, and laboratory assessments. Eligibility required stable background therapy if used, and all inclusion/exclusion criteria had to be met before randomisation.

    Pre-assignment period milestones
    Number of subjects started
    		 48
    Number of subjects completed
    		 48

    Period 1
    Period 1 title
    12 week period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RXC007 20 mg
    Arm description
    		 Subjects received RXC007 20 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable.”
    Arm type
    		 Experimental

    Investigational medicinal product name
    RXC007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RXC007 20 mg twice dailly. When administered twice daily, RXC007 must be taken approximately 12 hours apart between the morning and evening doses and patients must eat their meal as described above, 30 minutes prior to the evening dose of RXC00

    Arm title
    		 RXC007 50 mg
    Arm description
    		 Subjects received RXC007 50 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable
    Arm type
    		 Experimental

    Investigational medicinal product name
    RXC007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RXC007 was administered orally as capsules twice daily (BID) at fixed doses of 20 mg or 50 mg for 12 weeks during the double-blind treatment period.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    RXC007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules were administered orally twice daily (BID) for 12 weeks during the double-blind treatment period. The placebo was identical in appearance, packaging, and dosing schedule to the RXC007 capsules and was taken approximately 12 hours apart.

    Number of subjects in period 1
    		RXC007 20 mg RXC007 50 mg Placebo
    Started
    18
    18
    12
    Completed
    14
    16
    10
    Not completed
    4
    2
    2
         Consent withdrawn by subject
    2
    -
    1
         Adverse event, non-fatal
    2
    2
    1
    Period 2
    Period 2 title
    12 week period _OLE
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 RXC007 20 mg Open label extension
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    RXC007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RXC007 20 mg twice dailly. When administered twice daily, RXC007 must be taken approximately 12 hours apart between the morning and evening doses and patients must eat their meal as described above, 30 minutes prior to the evening dose of RXC00

    Arm title
    		 RXC007 50 mg Open label extension
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    RXC007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RXC007 was administered orally as capsules twice daily (BID) at fixed doses of 20 mg or 50 mg for 12 weeks during the double-blind treatment period.

    Number of subjects in period 2
    		RXC007 20 mg Open label extension RXC007 50 mg Open label extension
    Started
    10
    14
    Completed
    10
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RXC007 20 mg
    Reporting group description
    		 Subjects received RXC007 20 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable.”

    Reporting group title
    RXC007 50 mg
    Reporting group description
    		 Subjects received RXC007 50 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 RXC007 20 mg RXC007 50 mg Placebo Total
    Number of subjects
    		 18 18 12 48
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 5 4 2 11
        From 65-84 years
    		 13 14 10 37
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.4 ( 5.88 ) 69 ( 6.52 ) 70.8 ( 6.06 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 5 11
        Male
    		 15 15 7 37

    End points

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    End points reporting groups
    Reporting group title
    RXC007 20 mg
    Reporting group description
    		 Subjects received RXC007 20 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable.”

    Reporting group title
    RXC007 50 mg
    Reporting group description
    		 Subjects received RXC007 50 mg twice daily for 12 weeks during the double-blind period and could remain on stable background antifibrotic therapy (nintedanib or pirfenidone) if applicable

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    RXC007 20 mg Open label extension
    Reporting group description
    		 -

    Reporting group title
    RXC007 50 mg Open label extension
    Reporting group description
    		 -

    Primary: Incidence of adverse events and tolerability of RXC007 after 12 weeks of twice-daily oral dosing in subjects with idiopathic pulmonary fibrosis.

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    End point title
    		 Incidence of adverse events and tolerability of RXC007 after 12 weeks of twice-daily oral dosing in subjects with idiopathic pulmonary fibrosis.
    End point description
    Safety and tolerability assessed through incidence, severity, and relationship of TEAEs, SAEs, and discontinuations due to adverse events.
    End point type
    Primary
    End point timeframe
    Baseline to week 12.
    End point values
    		 RXC007 20 mg RXC007 50 mg Placebo
    Number of subjects analysed
    18
    18
    12
    Units: Number of subjects
    15
    15
    7
    Statistical analysis title
    		 TEAEs,SAE and AE
    Statistical analysis description
    Incidence of TEAEs and SAEs summarized as number (%) of subjects by treatment group
    Comparison groups
    RXC007 20 mg v RXC007 50 mg v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9999 [1]
    Method
    		 Descriptive summary statistics
    Confidence interval
    Notes
    [1] - Not applicable

    Secondary: Change from baseline in percent predicted and absolute forced vital capacity (FVC) at Week 12.

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    End point title
    		 Change from baseline in percent predicted and absolute forced vital capacity (FVC) at Week 12.
    End point description
    Spirometry was performed at baseline and Week 12 to assess change in FVC % predicted, a measure of pulmonary function. The LS Mean change from baseline was compared between RXC007 and placebo using ANCOVA.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12.
    End point values
    		 RXC007 20 mg RXC007 50 mg Placebo
    Number of subjects analysed
    17
    17
    12
    Units: percent
        least squares mean (standard error)
    -1.55 ( 0.86 )
    -3.00 ( 0.83 )
    -3.50 ( 0.90 )
    Statistical analysis title
    		 Primary Analysis of Efficacy analysis
    Comparison groups
    RXC007 20 mg v RXC007 50 mg v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1226
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Pharmacokinetic parameters of RXC007 (AUC₀–₁₂ h, Cmax, Tmax)_after multiple oral doses_C1D1

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    End point title
    		 Pharmacokinetic parameters of RXC007 (AUC₀–₁₂ h, Cmax, Tmax)_after multiple oral doses_C1D1
    End point description
    Plasma RXC007 concentrations were measured at predefined timepoints to calculate pharmacokinetic parameters (AUC₀–₁₂ h, Cmax, Tmax).
    End point type
    Secondary
    End point timeframe
    This was assessed at 2 time points: Cycle 1 Day 1 (Baseline) and Cycle 1 Day 8 (The plasma PK parameters derived for RXC007 are summarised in Table 15 in the CSR for C1D1 and C1D8)
    End point values
    		 RXC007 20 mg RXC007 50 mg Placebo
    Number of subjects analysed
    18
    18
    0 [2]
    Units: AUC₀–₁₂ h = ng·h/mL; Cmax = ng/mL; Tmax
        geometric mean (geometric coefficient of variation)
    241 ( 29 )
    564 ( 27.8 )
    ( )
    Notes
    [2] - PK not assessed for placebo. RXC007 is not given
    No statistical analyses for this end point

    Secondary: Pharmacokinetic parameters of RXC007 (AUC₀–₁₂ h, Cmax, Tmax)_after multiple oral doses_C1D8

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    End point title
    		 Pharmacokinetic parameters of RXC007 (AUC₀–₁₂ h, Cmax, Tmax)_after multiple oral doses_C1D8
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 8 ( C1D8)
    End point values
    		 RXC007 20 mg RXC007 50 mg Placebo
    Number of subjects analysed
    18
    18
    12
    Units: AUC₀–₁₂ h = ng·h/mL; Cmax = ng/mL; Tmax
        geometric mean (geometric coefficient of variation)
    332 ( 37 )
    791 ( 30.4 )
    0 ( 0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were summarised for events that occurred from the first dose of study drug up to 28 days after the last dose.
    Adverse event reporting additional description
    Adverse events were monitored from consent to end of follow-up. Investigators questioned subjects at each visit, reviewed vitals, labs, and ECGs, and recorded all TEAEs in the eCRF. Events were coded with MedDRA, graded by CTCAE guide , and reviewed by the Data Review Committee.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    RXC007 20 mg BID
    Reporting group description
    		 Subjects received RXC007 20 mg twice daily for 12 weeks during the double-blind treatment period.

    Reporting group title
    RXC007 50 mg BID
    Reporting group description
    		 Subjects received RXC007 50 mg twice daily for 12. weeks during the double-blind treatment period

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo tablets twice daily for 12 weeks during the double-blind treatment period.

    Serious adverse events
    		 RXC007 20 mg BID RXC007 50 mg BID Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Ischaemic attack
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral pneumonia and Dyspnoea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RXC007 20 mg BID RXC007 50 mg BID Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    Respiratory, thoracic and mediastinal disorders
    Cough,Dyspnoea
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2023
    • Summary of safety data from the Phase 1 study updated following completion of MAD cohorts • Update of inclusion criteria# 3 and 4 (and assessment of efficacy text) to clarify on use of histopathology to confirm UIP diagnosis in the case of indeterminate HRCT central read assessments • Clarification on Cohort 3 dosing in the event a lower dose was selected • Text added to state EOT visit in the translational science sub study should be Cycle 2 Day 1 if the patient did not continue past 28 days dosing. Further clarification on EOT visit for main study and first study visit for OLE • Plans for dose escalation/dose review amended: Dose review committee meeting text updated with respect assessment of safety data and ad hoc meetings; updated wording on dose escalation stopping criteria; clarification on causal relationship of events, and that exact preferred term match was not needed to be considered same events • Amended stopping rules so that they applied at any point in the treatment period, confirmed that treatment was to be discontinued in cases in Hy’s law, and provided clarification on causal relationship • Segregation of main study and OLE in the trial timetable for clarity, with new section added to explain OLE schedule of visits further, and new Appendix 3 added (separate SoA for OLE) • Correction of sampling timepoints for spirometry and DLCO. Correction of bronchoscopy sampling days in the translational sub study
    21 Jul 2023
    • Addition of PBMC collection at selected sites as exploratory objective/endpoint of the main study • Clarified that bronchial absorption samples in the translation sub study were to be collected at selected sites only • Clarified that the translation sub-study was no longer to run in parallel with the main study and that it may run in up to 2 cohorts (up to 16 patients • Plans for dose escalation/dose review amended, so information regarding progression to cohort 3b (translational sub study) removed. Clarified that additional patients could be randomised to lower doses

    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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