Linezolid

Persica Pharmaceuticals’ research published in Journal of Orthopaedic Research Spine ahead of anticipated clinical data in 2025 Persica is developing PP353, a potentially curative, opioid-sparing treatment for patients with chronic Low Back PainPersica’s work builds on substantial evidence that chronic Low Back Pain with Modic changes can be caused by a bacterial infection of the vertebral discPP353 is a novel, patented antibiotic preparation for intradiscal injection to treat the infection and provide long-term pain reliefTwo papers published in Journal of Orthopaedic Research Spine show the promise of PP353 through preclinical development and the First-in-Human data, laying the groundwork for safety and efficacy results from The Modic Trial, expected in Q1 2025 London, UK, 19 November 2024 - Persica Pharmaceuticals Limited (Persica), a clinical stage pharmaceutical company developing an antibiotic formulation for intradiscal injection to treat chronic Low Back Pain (cLBP), today announces the publication of two papers describing the preclinical development and First-in-Human pharmacokinetics of Persica’s asset, PP353, in the peer-reviewed Journal of Orthopaedic Research (JOR) Spine. Dr Steve Ruston, Chief Executive Officer of Persica, said: “Chronic Low Back Pain is a debilitating condition that significantly affects quality of life for millions of people, many of whom are not helped by existing treatments, often resulting in long-term reliance on analgesics such as opioids to manage pain. The papers published today in JOR Spine summarise our journey so far in the development of PP353, a ground-breaking therapy which could positively transform the lives of cLBP patients with Modic changes. We are looking forward to seeing the results from our Phase 1b Modic Trial which will be available in Q1 2025.” Some cLBP patients have pathological changes in the vertebrae of the spine, described as Modic changes, which are visible on MRI scans. These Modic changes can be caused by a localised and chronic bacterial infection in the spinal discs between the vertebrae, which leads to prolonged and debilitating pain. Persica’s work stems from the breakthrough findings from its founders who conducted a randomised, double-blind, placebo-controlled clinical trial1 which demonstrated that an oral antibiotic delivered over 100 days offered significant clinical benefit for a number of patients by treating the bacterial infection. Prolonged oral antibiotic therapy is poorly tolerated, however, and requires diligent compliance; moreover, its widespread use is precluded by the anticipated antibiotic resistance its adoption would bring. The research published in JOR Spine describes the development of PP353, designed for intradiscal injection under image guidance to provide substantial antibiotic exposure at the infected site, thereby minimising side-effects and microbial resistance. The first paper, “Preclinical development and characterisation of PP353, a formulation of linezoid for intradiscal administration”, details the preclinical development of the assetThe second paper, “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”, gives results from Part A of Persica’s Phase Ib Modic Trial, showing that PP353 was well tolerated with no serious adverse events in this open-label single-dose phase of the study Results from Part B of the Phase Ib 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 changes, are expected in Q1 2025. Ends For further information:ICR Healthcare:Tracy Cheung, Chris Welsh, Emily Johnsonpersica@icrhealthcare.com The papers published in JOR Spine Preclinical development and characterisation of PP353, a formulation of linezolid for intradiscal administration. Graham Hagger, Sarah Guest, Stephen Birchall, Alys Bradley, Charlie Brindley, David Corbett, Paul J. Cummings, Cristina Freire, James Harris, Andrew Wise, Melanie Wood, Lloyd G. Czaplewski JOR Spine https://doi.org/10.1002/jsp2.70010 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. Shiva S Tripathi, Robert Sneath, Aprajay Golash, Parag Desai, Duncan McHale, Sarah Guest, Charlie Brindley, Paul Cummings, Shane Smith, Conrad Stroud, Graham Scott, Steve Ruston, Lloyd Czaplewski. JOR Spine JOR Spine https://doi.org/10.1002/jsp2.70009 About Persica Pharmaceuticals Persica Pharmaceuticals is a clinical stage pharmaceutical company developing PP353, a novel, patented intradiscal antibiotic injection to treat chronic Low Back Pain with vertebral body endplate bone oedema (Modic 1). The Company was founded by Mr Peter Hamlyn, Dr Alan Jordan, Professor Claus Manniche, Professor Hanne Albert, Dr Eliot Forster and Christopher Welch in 2013. www.persicapharmaceuticals.com 1 Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13. PMID: 23404353; PMCID: PMC3631045.

MANILA (September 3, 2024) – A delegation of experts from Brazil’s National TB Program visited Manila recently to collaborate with the Philippines to accelerate implementation of the new drug-resistant TB (DR-TB) treatment, BPaL/M. Through the Manila-based PeerLINC Knowledge Hub, Brazilian officials had in-depth scientific exchange with their peers in the Philippines – one of the first countries in the world to successfully roll out BPaL/M treatment. PeerLINC is supported by TB Alliance and offers countries like Brazil first-in-class peer support, capacity building, and technical assistance to implement the life-saving regimen in their own countries. BPaL/M – a combination of the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M) – are six-month DR-TB treatments with a success rate of 90% or greater. BPaL/M is recommended by the World Health Organization (WHO) for the treatment of most forms of DR-TB. Prior to the introduction of these regimens, DR-TB treatment typically consisted of 9-24 months of treatment, with a treatment success rate of approximately 60%. New regimens have the potential to improve DR-TB treatment outcomes and experiences in Brazil, while reducing costs to both health systems and individuals who seek treatment. “Brazil has decided to fast track implementation of BPaL/M,” says Dr. Fernanda Dockhorn. “We had valuable interactions with the PeerLINC team and Philippines Department of Health Disease Prevention and Control Bureau (DPCB) experts to utilize their experience as we deploy this new standard of care in our country. We are thankful to TB Alliance for supporting this interaction and DPCB for their help.” The intensive week-long programme included didactic and hands-on training with experts from PeerLINC, the Philippines Department of Health, the Lung Center of the Philippines, and the National TB Reference Laboratory (NTRL). The PeerLINC team also provides ongoing support and technical assistance as Brazil implements the new treatment regimens. “It is truly heartening and exciting to see this initiative working so well,” said Sandeep Juneja, Senior Vice President of Access at TB Alliance. “We’re seeing countries with substantial TB burdens working with the PeerLINC team and returning home with deeper knowledge, strengthened commitment, and tangible plans to expand and accelerate access to new TB cures that will benefit their people and health systems.” PeerLINC Knowledge Hub operates as a partnership between TB Alliance and the Tropical Disease Foundation, Inc. (TDF), and in close collaboration with the Department of Health (DOH), Philippines, to help countries implement best practices in the treatment of drug-resistant tuberculosis (DR-TB) and speed the worldwide programmatic implementation of innovative, more effective treatments for the disease. The initiative is funded by the Australian Government through the Partnerships for a Healthy Region initiative. Since launching in March 2024, PeerLINC has helped numerous counties define and operationalize plans to expand availability of the BPaL/M, including Brazil, Peru, Nigeria, Rwanda, and Democratic Republic of Congo. About BPaL The BPaL regimen – which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L) – was designed and clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019, for use against highly drug-resistant strains of TB. Prior to the initial BPaL clinical trial, less than one-third of drug-resistant TB patients were being successfully treated. Treatment options were limited, expensive, toxic, and lengthy, requiring patients to take more than 20 pills per day for 9-20 months. About PeerLINC The PeerLINC Knowledge Hub provides practical training and technical support to help speed programmatic implementation of innovative, effective TB treatments globally. PeerLINC follows a peer-to-peer model for sharing best practices, experience, tools, and materials by connecting experts from early adopter countries with countries interested in implementing the latest TB treatments. PeerLINC, operates in partnership between the Tropical Disease Foundation, Inc. (TDF) and TB Alliance in close collaboration with the Department of Health, Philippines. PeerLINC Knowledge Hub New PeerLINC Knowledge Hub will Leverage Local Expertise and Experience to Accelerate New, More Effective TB Cures Around the World Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB