Persica002 Phase1B PP353 vs Placebo in the treatment of low back pain

• Research type

  Research Study

• Full title

  A PHASE 1B STUDY INVESTIGATING THE SAFETY, TOLERABILITY AND EFFICACY OF PP353 IN THE TREATMENT OF PATIENTS WITH CHRONIC LOW BACK PAIN ASSOCIATED WITH VERTEBRAL BODY ENDPLATE BONE OEDEMA (MODIC 1)

• IRAS ID

  255324

• Contact name

  Steve Ruston

• Contact email

  steve.ruston@persicapharmaceuticals.com

• Sponsor organisation

  Persica Pharmaceuticals Limited

• Eudract number

  2018-004488-30

• Duration of Study in the UK

  3 years, 1 months, 1 days

• Research summary

  Research Summary:

  This is a two-part study, each of 12 months’ duration, in subjects with chronic low back pain (CLBP) associated with vertebral body endplate bone oedema (Modic 1), as detected by MRI. In both parts of the study, the subject population will not have been previously treated with antibiotic agents for their back pain. Subjects will be treated with up to 3 intradiscal injections of the study drug PP353. PP353 contains an antibiotic (linezolid) and has been specially designed to treat infections in the infected disc.

  Part A of the study is open label to evaluate the safety, tolerability and pharmacokinetics (PK) of PP353 in up to 6 subjects. Each subject will receive 1 injection of PP353. Information from Part A will be used to choose the number of injections needed for Part B.

  Part B of the study is a randomised, placebo-controlled, investigator- and subject-blinded, third-party unblinded and will evaluate the safety, tolerability and efficacy of a maximum of three administrations of PP353 or Placebo in 34 subjects.

  Summary of results:

  This is a summary of the main results from a clinical study with the investigational drug PP353. Persica Pharmaceuticals is the sponsor of the study and would like to share the results with the patients who participated in the study, and with the public.

  Thank you!
  Persica Pharmaceuticals would like to thank all the patients who participated in this study. All the patients and care givers helped the researchers to learn more about using PP353 in patients with chronic Low Back Pain.
  Researchers look at the results of many studies to understand which drugs work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary only shows the results from this one study.
  This is the first study to be conducted with the investigational drug (PP353). Other studies may find different results.
  If you were a patient in this study and have questions about the results, please ask the doctor at the study site.
  If you need medical advice about your chronic Low Back Pain, please contact your doctor. Changes to medication for chronic Low Back Pain should not be made based on the results of this single trial.

  Clinical trial identification
  Study name: A phase 1b study investigating the safety, tolerability and efficacy of PP353 in the treatment of patients with chronic low back pain associated with vertebral body endplate bone oedema (Modic 1) Protocol number: Persica 002 Other identifiers:
  EU Trial number: 2018-004488-30
  Universal Trial Number: U1111-1257-2567
  Clinicaltrials.gov number: NCT04238676

  Abstract
  Purpose of the study: To see if PP353 helps to improve the symptoms of chronic Low Back Pain.
  What was tested: PP353 was compared to placebo in a Phase 1b trial.
  People taking part: 40 patients with chronic Low Back Pain which may have been caused by an infection took part in this trial in 4 countries
  Results: PP353 was better than placebo in improving the symptoms of chronic Low Back Pain. In this small study, researchers found that PP353 had a similar number of side effects as placebo.

  Who sponsored this study?
  Persica Pharmaceuticals Ltd
  Contact: info@persicapharmaceuticals.com

  General information about the clinical trial This trial took place in the following countries:
  • UK
  • Denmark
  • Spain
  • New Zealand
  This trial started in January 2020 and ended in December 2024 In this study, researchers looked at what happens to the drug once we inject it into the body and whether it helps people with chronic back pain. Patients with chronic Low Back Pain were included in the study. The researchers wanted to know if there were:
  • Any unwanted side effects of the drug
  • How long the drug stays in the body
  • Any improvements in chronic Low Back Pain symptoms
  The study was in 2 parts. In Part A, 3 patients received one injection of PP353 into a spinal disc. In Part B, 20 patients received 2 injections of PP353 into a spinal disc. Another 20 patients received placebo (a “sham/dummy” injection).
  Patients with chronic Low Back Pain were put into 2 groups randomly (by chance). One group received PP353 and the other group got placebo. Putting people into groups by chance helps to make the 2 groups equal. Reducing differences between the groups in this way, makes the comparison between the groups fairer.
  This trial was also “double-blinded”. This means that neither patients nor doctors knew who was given PP353 and who was given placebo. This was done to make sure that the trial results were not influenced in any way.

  Which patients were included in this study?
  This trial included patients in the following countries:
  • 18 patients in the UK
  • 11 patients in Denmark
  • 8 patients in New Zealand
  • 3 patients in Spain
  Belgium and France also screened patients for the study; however, no patients joined the study from these countries.

  Inclusion criteria
  • Aged between 18 and 70 years, inclusive.
  • Chronic low back pain in the area associated with Magnetic Resonance Imaging (MRI) changes know as Modic Type 1 changes
  • Moderate to severe low back pain
  • Moderate to severe disability due to low back pain
  • Low back pain that has lasted at least 6 months
  • Bodyweight of ≥ 50 kg and ≤ 120 kg.
  • The current standard therapies for back pain did not work

  Exclusion criteria
  • Any other condition or previous treatment that might also be causing back pain
  • Any other significant illness
  • Previously been treated with antimicrobial agents for low back pain or previously received any antimicrobial intradiscal injection.

  Which medicines were studied?
  PP353 is an investigational drug which contains an antibiotic called linezolid. PP353 has been designed to be injected into a spinal disc.
  Placebo was also used in this study. Patients who received placebo received dummy injections, where a needle was placed into their back, close to their disc. However, nothing was injected.

  What were the side effects?
  Side effects are unwanted medical events {such as a headache) that happen during the study and are reported because the trial doctor investigator believes the side effects were related to the treatments in the trial. Not all the people patients in this trial had side effects.

  Serious and common side effects are listed here:
  • No patients had any serious side effects that were considered related to PP353
  • In Part B of the study:
  • 7 out of 20 patients (35%) who received PP353 had side effects
  • 8 out of 20 patients (40%) who received placebo had side effects
  • Side effects for PP353 in Part B 2 injections of PP353) included:
  • Injection site pain in 2 out of 20 patients (10%)
  • Injection site reaction in 2 out of 20 patients (10%)
  • Back pain in 2 out of 20 patients (10%)
  • Side effects for placebo in Part B (2 “dummy” injections) included:
  • Injection site pain in 3 out of 20 patients (15%)
  • Sciatica in 2 out of 20 patients (10%)
  The side effects seen with PP353 were similar overall to the side effects seen with placebo.

  What were the overall results of the study?
  In the study, patients had to score their pain on a scale which ranged from zero (no pain) to 10 (the worst pain you can imagine). Patients had to score at least 6 on this scale to enter the study.
  Patients who received PP353 had an average reduction of 3.4 points in on the pain scale 12 months after the injections. Patients on placebo had an average reduction of 2.0 points on the pain scale 12 months after the injections.
  This result showed that PP353 was better at reducing pain than placebo in this group of patients with chronic Low Back Pain.

  How has this study helped patients and researchers?
  • This first small study with PP353 has demonstrated that antibiotics might help some patients with chronic Low Back Pain.
  • This is a single, small study and has limitations. Findings from this trial will be used in other larger studies to learn whether patients are helped by PP353.
  • Larger trials might show something different to this study.

  Are there plans for further studies?
  Further clinical trials with PP353 are planned but have not yet started.

  Where can I find more information about this study?
  To learn more about this study, you can find more detailed information on this website, where the results will be posted by the end of December 2025: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04238676%2FNBTI%2FF22_AQ%2FAQ%2F76cc3d73-9c26-4a76-b5d1-9831fe26371c%2F2%2FPvyXBf3S5Z&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Cbf1f423004634f5c1c1708ddba0ab58d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638871277330544738%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wt3Sevgqu6PACxyvEj7yyVsBzz4jjH7xijN9IZbqYOc%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  19/YH/0096

• Date of REC Opinion

  24 May 2019

• REC opinion

  Further Information Favourable Opinion