Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

NCT04238676 | Completed Phase 1 Results

• 3 other identifiers: Persica 0022018-004488-30U1111-1257-2567
• Study Type: interventional
• Target: 43
• Locations: 4 countries
• Sites: 10

Brief Summary

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

Conditions

Chronic Low-back Pain

Keywords

Back pain; Low back pain; Lower back pain; Modic

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event

  0 to 12 months

• Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score

  Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." A lower score indicates less pain. The Low Back Pain Numerical Rating score throughout this protocol is defined as the average of the score of the three questions: 1. Low back pain intensity now 2. Worst low back pain intensity in the last 14 days 3. Average low back pain intensity over the last 14 days Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.

  12 months

Secondary Outcomes (3)

• Change From Baseline in Roland Morris Disability Questionnaire-23 Score

  12 months

• Clinically Relevant Improvement (≥30%) in RMDQ-23

  12 months

• Change From Baseline in Oswestry Disability Index

  12 months

Other Outcomes (1)

• Change From Baseline of Average Low Back Pain (LBP) Intensity Numerical Rating Scale (NRS) Daily Score Over a 7-day Period

  12 months

Study Arms (2)

PP353

EXPERIMENTAL

Drug: PP353

Sham injection

PLACEBO COMPARATOR

Other: Placebo

Interventions

PP353 DRUG

active administered by intradiscal injection

PP353

Placebo OTHER

Sham injection

Sham injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years, inclusive.
• Chronic low back pain in the area associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2) at a single lumbar level.
• Average LBP NRS score at screening and at Day 1 pre-randomisation ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication; it should be higher than the leg pain NRS score
• RMDQ-23 score ≥ 9 at screening and at Day 1 pre-randomisation.
• Current episode of chronic low back pain has lasted for ≥ 6 months at the time of randomisation.
• Bodyweight of ≥ 50 kg and ≤ 120 kg.
• Failure of standard of care therapies used by their treating physician

You may not qualify if:

• Any vertebra with Modic 2 only lesions which:
• in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or
• are present within 2 vertebrae from the target lumbar disc.
• The target lumbar disc has lost more than half its original anticipated height at the centre or it is \< 5mm in height over the central 15 mm portion
• A clear alternative cause for back pain
• Gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints
• Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening
• History of alcohol abuse or drugs of abuse in the past 2 years
• Any other significant illness
• Previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.

Sponsors & Collaborators

• Micron Research Ltd: collaborator
• Persica Pharmaceuticals Ltd: lead

Study Sites (10)

Gildhøj Privathospital København

Copenhagen, 2605 Brøndby, Denmark

Location

CGM Research Trust

Christchurch, 8083, New Zealand

Location

Hospital Vithas Granada

Granada, Spain

Location

Hospital Universitario LA PAZ

Madrid, Spain

Location

Royal Preston Hospital

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxford, OX3 9DU, United Kingdom

Location

University Hospital Of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

University Hospital Coventry & Warwickshire

Coventry, CV2 2DX, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

University Hospital Southampton Nhs Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Tripathi SS, Sneath R, Golash A, Desai P, McHale D, Guest S, Brindley C, Cummings P, Smith S, Stroud C, Scott G, Ruston S, Czaplewski L. Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study. JOR Spine. 2024 Nov 14;7(4):e70009. doi: 10.1002/jsp2.70009. eCollection 2024 Dec.

  RESULT

• Lassen MR, Scarborough M, Gilchrist N, Tripathi SS, Price C, Horcajadas A, DeAndres J, Baranidharan G, Ahuja S, Otte KS, Wood E, Guest S, Czaplewski LG, McHale D; Modic Trial (TMT) group. Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial. EClinicalMedicine. 2026 Feb 2;92:103764. doi: 10.1016/j.eclinm.2026.103764. eCollection 2026 Feb.

  PMID: 41768986 RESULT

Related Links

• Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial
• Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Duncan McHale
• Organization: Weatherden Ltd

info@persicapharmaceuticals.com

+44 1227 910152

Study Officials

• Duncan McHale, MBBS MRCP

  Weatherden Ltd

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open label In Part B the pharmacist and injector will not be blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is open label Part B is parallel placebo controlled

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 23, 2020
• Study Start: January 20, 2020
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6); ES (2); DK (1); NZ (1)