Linezolid

Persica Pharmaceuticals said it has promising Phase 1b results that support its approach of using a two-dose antibiotic to treat a subset of patients with chronic back pain. Chronic low back pain in some people seems to be caused by so-called indolent infections in the lumbar disc, the London-based drugmaker said. These infections don’t behave like typical infections because they are persistent and there are none of the usual symptoms like fever, CEO Steve Ruston told Endpoints News in an interview. Bacteria in the disc can cause inflammation and bone degradation over time, which then triggers pain, Ruston added. The infection leads to changes — known as Modic changes — in the bone marrow that can be detected on an MRI scan. There are four different types of Modic changes, with type 1 signifying bone marrow swelling and inflammation. In a Phase 1b study of people with chronic low back pain and Modic type 1 changes, Persica’s antibiotic, dubbed PP353, achieved a 50% reduction in pain scores from baseline. This worked out to a roughly 30% reduction in pain scores compared with placebo, according to a Wednesday press release. The trial enrolled 44 patients who hadn’t benefited from non-surgical standard of care, such as physiotherapy and painkillers. The patients given the antibiotic experienced an average 63% reduction in their disability scores. Their pain and disability scores were still improving at 12 months, suggesting the treatment’s effect improves over time, the company said. PP353 contains a combination of the antibiotic linezolid, contrast agent iohexol and a thermosensitive gel. It is injected into the lumbar disc in two doses given four days apart in an effort to eliminate the infection. Persica’s antibiotic approach is markedly different from other non-opioid drugs in clinical development for acute or chronic pain. Many other companies are advancing voltage-gated sodium channel blockers. Vertex’s Journavx became the first drug from this class to secure FDA approval for acute pain back in January. Other targets being explored for pain include AAK1 and NMDA. Persica is preparing for regulatory discussions to advance PP353 into registrational development. While the asset is unique, its components have been used in other drug products, which makes a stronger case for faster development, Ruston said. Chronic low back pain patients with Modic type 1 changes are a “common” subgroup, with more than two million of them in the US alone, according to Persica. Besides non-surgical options, the only other treatment is nerve ablation surgery, which doesn’t address the root cause of the condition.

Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued progression as planned MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in patients with diabetic foot infections (DFI), meeting expectations SHANGHAI, Feb. 25, 2025 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced significant progress in its global multicenter Phase III clinical trial evaluating MRX-4 Injection followed by Contezolid Tablets for the treatment of DFI. The DMC has completed its first safety and efficacy assessment, confirming that the drug's safety and efficacy profiles meet favorable expectations and recommending the trial proceed as planned. DMC Endorsement: Safety and Efficacy Meet Favorable Expectations This evaluation was conducted in accordance with the DMC charter, analyzing the safety and efficacy data of the first 33% of enrolled subjects (285 cases) who completed the study. The results showed that MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in treating moderate-to-severe DFI patients, meeting expectations. Based on this, the DMC unanimously recommended no adjustments to the trial, injecting confidence into subsequent clinical advancement. Addressing Unmet Needs and Targeting Global Markets DFI is one of the severe complications of diabetes. In China, the number of DFI patients was 4.76 million in 2018, growing to 5.2 million by 2024 at a compound annual growth rate (CAGR) of 1.5%. It is projected to reach 5.36 million by 2030 and 5.42 million by 2035. In the United States, 3.65 million patients suffered from DFI in 2018, increasing to 3.76 million by 2024 at a CAGR of 0.5%. The number is expected to rise to 3.84 million by 2030 and 3.89 million by 2035. Antibiotic therapy is the cornerstone of DFI treatment. MRX-4 Injection and Contezolid Tablets, as a new generation of oxazolidinone antibiotics, reduce risks such as myelosuppression—common with traditional therapies—through structural optimization, making them particularly suitable for patients requiring long-term treatment. Contezolid Tablets, approved in China in 2021 for complicated skin and soft tissue infections (cSSTI), have already demonstrated robust clinical safety. MRX-4, a water-soluble prodrug of Contezolid, converts into Contezolid in vivo to exert therapeutic effects. In 2023, both Contezolid Tablets and MRX-4 received U.S. FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating moderate-to-severe DFI without concurrent osteomyelitis. This global Phase III trial is an international multicenter, randomized, double-blind, controlled study comparing MRX-4 Injection followed by Contezolid Tablets with linezolid in treating moderate-to-severe DFI patients. The trial plans to enroll 865 patients, with a treatment duration of 14 to 28 days. Mr. Jerry Li, CFO and President of MicuRx U.S., stated, "The DMC's positive evaluation underscores the promising efficacy and safety of MRX-4 Injection and Contezolid Tablets, marking a critical milestone toward global market entry. We anticipate this therapy will offer DFI patients a safer treatment option while addressing antibiotic resistance challenges." Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, emphasized, "The development of MRX-4 and Contezolid has always focused on unmet clinical needs. DFI patients urgently require better-tolerated innovative therapies suitable for long-term use, and the current data further validate their potential." Forward-Looking Statements This press release contains certain forward-looking statements. These statements are not historical facts but are based on the Company's current predictions or expectations regarding future events based on available data and information. Words such as "anticipate," "believe," "continue," "may," "estimate," "expect," "intend," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, though not all such statements include these specific terms. These forward-looking statements involve known and unknown uncertainties and other significant factors that may cause actual results to differ materially from those expressed or implied due to risks associated with policy, R&D, market conditions, regulatory uncertainties, and other variables. Existing and potential investors are cautioned to carefully evaluate these risks and not to rely unduly on the forward-looking statements herein. Any forward-looking statements contained in this press release are made only as of the date of this press release. Unless required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED