linezolid suspension intradiscal (PP353) / Persica Pharma - LARVOL DELTA

Persica Pharmaceuticals announces positive Phase 1b clinical data for PP353, a novel, non-opioid intradiscal injection for the treatment of chronic Low Back Pain (GlobeNewswire) - P1b | N=44 | Modic 1 (NCT04238676) | Sponsor: Persica Pharmaceuticals Ltd | "Persica Pharmaceuticals Limited...today announces positive topline data from its Phase 1b Modic Trial, a randomised, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with cLBP associated with Modic Type 1 changes....The PP353 clinical trial met the primary endpoint and demonstrated statistically significant and clinically meaningful results in patients with chronic Low Back Pain with Modic Type 1 changes, with a 3.4-point (50%) within-group reduction in pain from baseline and a 1.4-point (30%) between-group reduction from placebo at 12 months in the Full Analysis Set of subjects."

P1 data • Back Pain • CNS Disorders

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1/2 | N=44 | Completed | Sponsor: Persica Pharmaceuticals Ltd | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Preclinical development and characterisation of PP353, a formulation of linezolid for intradiscal administration. (PubMed, JOR Spine) - "Linezolid can be formulated for image-guided percutaneous intradiscal administration. The formulation is now in a Phase 1b clinical trial to evaluate safety, pharmacokinetics, and efficacy in patients with CLBP and suspected bacterial infection."

Journal • Preclinical • Back Pain • Infectious Disease • Lumbar Back Pain • Musculoskeletal Pain • Pain

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. (PubMed, JOR Spine) - "Pharmacokinetic deconvolution estimated that a single dose of PP353 (150 mg linezolid) provided intradiscal bactericidal concentration of linezolid for 96 h and bacteriostatic exposure for up to 120 h after dosing. Intradiscal administration of 3 mL of PP353 is well-tolerated and based on the pharmacokinetics following a single injection, a two-dose regimen of PP353 (150 mg linezolid) on Day 1 and Day 5 ± 1 was selected to explore safety, tolerability, pharmacokinetics, and efficacy in Part B of the Persica 002 study."

Journal • P1 data • PK/PD data • Back Pain • Infectious Disease • Lumbar Back Pain • Musculoskeletal Pain • Pain

Persica Pharmaceuticals completes recruitment into Modic Trial assessing efficacy of PP353, to treat chronic lower back pain (GlobeNewswire) - "Persica Pharmaceuticals Ltd...today announces the completion of enrolment of participants into its Phase 1b Modic Trial. The trial is being conducted in the UK, Denmark, New Zealand and Spain....The Modic Trial is a placebo-controlled randomised clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with CLBP associated with Modic 1 changes. All 40 subjects have been enrolled and randomised 1:1 to placebo sham treatment or PP353 with no safety issues reported. The trial primary outcome measures include safety and patient-reported low back pain over 12-months. Other outcome measures include patient reported low back pain, disability, volume of vertebral bone oedema and pharmacokinetics at intermediate time points and at 12-months."

Enrollment closed • CNS Disorders • Lumbar Back Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1/2 | N=43 | Active, not recruiting | Sponsor: Persica Pharmaceuticals Ltd | Recruiting ➔ Active, not recruiting | Phase classification: P1b ➔ P1/2

Enrollment closed • Phase classification • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b | N=43 | Recruiting | Sponsor: Persica Pharmaceuticals Ltd | Trial completion date: Jul 2023 ➔ Oct 2024 | Trial primary completion date: Jul 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Peter Hamlyn, Founder and Director of Persica Pharmaceuticals will be presenting at the British Association of Spine Surgeons (BioSpace) - "Persica Pharmaceuticals Ltd...announces that Peter Hamlyn, founding member and Non-Executive Director of Persica will be presenting at the 2022 British Association of Spine Surgeons (BASS) meeting, taking place in Belfast on 23-25 March 2022....There is now substantial evidence that in patients with Modic 1, representing at least 20% of all CLBP populations, the underlying disease mechanism is localised chronic disc infection with anaerobic bacteria. Independent randomised controlled clinical trials have shown that high-dose, broad-spectrum oral antibiotics over a period of 90-100 days can be highly effective in the treatment of CLBP associated with Modic."

Clinical • CNS Disorders • Lumbar Back Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b | N=43 | Recruiting | Sponsor: Persica Pharmaceuticals Ltd | Trial completion date: Feb 2023 ➔ Jul 2023 | Trial primary completion date: Feb 2023 ➔ Jul 2023

Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b; N=43; Recruiting; Sponsor: Persica Pharmaceuticals Ltd; Trial completion date: May 2022 ➔ Feb 2023; Trial primary completion date: May 2022 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Persica Pharmaceuticals has completed the first stage of its clinical trial on unique injectable PP353, to treat chronic lower back pain (GlobeNewswire) - P1b, N=40; NCT04238676; Sponsor: Persica Pharmaceuticals Ltd; "Persica Pharmaceuticals...announces that it has successfully completed the first stage of a Phase Ib clinical trial to evaluate the safety, tolerability and pharmacokinetics of PP353....Three subjects received 3 mL intradiscal injections of PP353. The results were reviewed by the study Safety Review Committee which concluded that that PP353 was safe, well tolerated, the pharmacology was consistent and demonstrated prolonged exposure. The Committee recommended that efficacy of a two-dose regimen of PP353 be tested in the next stage of clinical evaluation....Efficacy of PP353 will now be evaluated in a placebo-controlled randomised clinical trial assessing patient reported low back pain and disability in the UK, mainland Europe and New Zealand."

DSMB • P1 data • PK/PD data • Trial completion • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Persica Pharmaceuticals Ltd; Trial completion date: Sep 2021 ➔ May 2022; Trial primary completion date: Sep 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Persica Pharmaceuticals Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain (clinicaltrials.gov) - P1b; N=40; Not yet recruiting; Sponsor: Persica Pharmaceuticals Ltd

Clinical • New P1 trial